Onureg Patent Expiration

Onureg is a drug owned by Bristol Myers Squibb Co. It is protected by 3 US drug patents filed from 2020 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 03, 2030. Details of Onureg's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8846628 Oral formulations of cytidine analogs and methods of use thereof
Jun, 2030

(3 years from now)

Active
US12053482 Oral formulations of cytidine analogs and methods of use thereof
May, 2029

(2 years from now)

Active
US11571436 Oral formulations of cytidine analogs and methods of use thereof
May, 2029

(2 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Onureg's patents.

Given below is the list of recent legal activities going on the following patents of Onureg.

Activity Date Patent Number
Patent litigations
Patent eGrant Notification 06 Aug, 2024 US12053482
Mail Patent eGrant Notification 06 Aug, 2024 US12053482
Patent Issue Date Used in PTA Calculation 06 Aug, 2024 US12053482
Email Notification 06 Aug, 2024 US12053482
Recordation of Patent eGrant 06 Aug, 2024 US12053482
Recordation of Patent Grant Mailed 06 Aug, 2024 US12053482
Email Notification 18 Jul, 2024 US12053482
Issue Notification Mailed 17 Jul, 2024 US12053482
Dispatch to FDC 09 Jul, 2024 US12053482
Application Is Considered Ready for Issue 09 Jul, 2024 US12053482


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Onureg and ongoing litigations to help you estimate the early arrival of Onureg generic.

Onureg's Litigations

Onureg been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 10, 2023, against patent number US8846628. The petitioner Apotex Inc. et al., challenged the validity of this patent, with CELGENE CORPORATION et al. as the respondent. Click below to track the latest information on how companies are challenging Onureg's patents.

Last updated on October 20, 2026
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8846628 February, 2023 Terminated-Settled
(05 Jan, 2024)
CELGENE CORPORATION et al. Apotex Inc. et al.


FDA has granted some exclusivities to Onureg. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onureg, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Onureg.

Exclusivity Information

Onureg holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Onureg's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 01, 2023
Orphan Drug Exclusivity(ODE-320) Sep 01, 2027

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Several oppositions have been filed on Onureg's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Onureg's generic, the next section provides detailed information on ongoing and past EP oppositions related to Onureg patents.

Onureg's Oppositions Filed in EPO

Onureg has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 27, 2019, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP09746975A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP20201105A Apr, 2023 STADA Arzneimittel AG Granted and Under Opposition
EP20201105A Apr, 2023 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP20201105A Mar, 2023 Synthon BV Granted and Under Opposition
EP20201105A Mar, 2023 Hamm&Wittkopp Patentanwälte PartmbB Granted and Under Opposition
EP20201105A Mar, 2023 SANDOZ AG Granted and Under Opposition
EP19213148A May, 2022 STADA Arzneimittel AG Granted and Under Opposition
EP19213148A May, 2022 Generics [UK] Limited Granted and Under Opposition
EP19213148A May, 2022 TEVA PHARMACEUTICAL INDUSTRIES, LTD. Granted and Under Opposition
EP19213148A May, 2022 Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB Granted and Under Opposition
EP19213148A May, 2022 SANDOZ AG Granted and Under Opposition
EP19213148A Apr, 2022 Lotus Pharmaceutical Co., Ltd. Granted and Under Opposition
EP13182721A Sep, 2020 SANDOZ AG Granted and Under Opposition
EP13182721A Sep, 2020 Hoffmann Eitle Granted and Under Opposition
EP13182721A Sep, 2020 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP13182721A Aug, 2020 Generics (U.K.) Limited Granted and Under Opposition
EP09746975A Aug, 2019 Generics (UK) Ltd Granted and Under Opposition
EP09746975A Aug, 2019 Teva Pharmaceutical Industries Ltd Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Onureg is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Onureg's family patents as well as insights into ongoing legal events on those patents.

Onureg's Family Patents

Onureg has patent protection in a total of 34 countries. It's US patent count contributes only to 17.5% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Onureg.

Family Patents

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Clinical Trials

Recent Clinical Trials on Onureg:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia Beat AML, LLC NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine Groupe Francophone des Myelodysplasies NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Jennifer Saultz NA RECRUITING
(Sep 1, 2026)
PHASE1
Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML GWT-TUD GmbH NA COMPLETED
(Sep 1, 2026)
PHASE2
Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies Seagen, a wholly owned subsidiary of Pfizer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study of BGB-11417 in Participants With Myeloid Malignancies BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE2
Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia Astellas Pharma Global Development, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML Guangzhou Lupeng Pharmaceutical Company LTD. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia St. Jude Children's Research Hospital NA RECRUITING
(Sep 1, 2026)
PHASE2
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML Stichting Hemato-Oncologie voor Volwassenen Nederland NA RECRUITING
(Sep 1, 2026)
PHASE2
Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine (DEC3-VEN) vs. Venetoclax in Combination With Azacitidine (VIALE-A) in the Treatment of Elderly Patients or Unfit, New-diagnosis Acute Myeloid Leukemia Patients The Second Affiliated Hospital of Kunming Medical University NA COMPLETED
(Sep 1, 2026)
PHASE3
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation Institut de Recherches Internationales Servier NA RECRUITING
(Sep 1, 2026)
PHASE3
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML OHSU Knight Cancer Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm M.D. Anderson Cancer Center NA WITHDRAWN
(Sep 1, 2026)
PHASE2
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome) M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia Sichuan Baili Pharmaceutical Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax Timothy Pardee NA RECRUITING
(Sep 1, 2026)
PHASE2
Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML UNC Lineberger Comprehensive Cancer Center NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy Ipsen NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Metronomic Decitabine-Cedazuridine and Venetoclax in R/R AML, HR-MDS, HR/AP MPN Virginia Commonwealth University NA RECRUITING
(Sep 1, 2026)
PHASE2
Homoharringtonine, Lisaftoclax, and Azacitidine for AML After Venetoclax-Based Therapy Failure Guangdong Second Provincial General Hospital NA ENROLLING BY INVITATION
(Sep 1, 2026)
PHASE2
Hydrochloroquinine & Decitabine With Venetoclax in AML Rutgers, The State University of New Jersey NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma National Cancer Institute (NCI) NA SUSPENDED
(Aug 24, 2026)
PHASE1
Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome Groupe Francophone des Myelodysplasies NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome Groupe Francophone des Myelodysplasies NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT University of Birmingham NA COMPLETED
(Aug 1, 2026)
PHASE3
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Takeda NA COMPLETED
(Aug 1, 2026)
PHASE2
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome Taiho Pharmaceutical Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) PedAL BCU, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) National Cancer Institute (NCI) NA RECRUITING
(Aug 1, 2026)
PHASE2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial) National Cancer Institute (NCI) NA RECRUITING
(Aug 1, 2026)
PHASE2
Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes Groupe Francophone des Myelodysplasies NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia Therapeutic Advances in Childhood Leukemia Consortium NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML Technische Universität Dresden NA RECRUITING
(Aug 1, 2026)
PHASE2
Pacritinib in CMML Douglas Tremblay NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Cladribine Venetoclax in Monocytic AML University of Colorado, Denver NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) National Cancer Institute (NCI) NA RECRUITING
(Aug 1, 2026)
PHASE2
Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML The First Affiliated Hospital of Soochow University NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy Stemline Therapeutics, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML National Cancer Institute (NCI) NA SUSPENDED
(Aug 1, 2026)
PHASE1
Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia Uma Borate NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML Stichting Hemato-Oncologie voor Volwassenen Nederland NA RECRUITING
(Aug 1, 2026)
PHASE3
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia Memorial Sloan Kettering Cancer Center NA WITHDRAWN
(Aug 1, 2026)
PHASE2
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML Kura Oncology, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE3
Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms University of Washington NA RECRUITING
(Aug 1, 2026)
PHASE2
Pilot Study of Reduced Venetoclax Exposure Northwell Health NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML) Kittika Poonsombudlert NA RECRUITING
(Aug 1, 2026)
PHASE1
Pacritinib With Aza for Upfront Myelodysplastic Syndrome Thomas Jefferson University NA WITHDRAWN
(Aug 1, 2026)
PHASE1, PHASE2
FH-WT1-E50 TCR T Cells With Azacitidine for the Treatment of Minimal Residual Disease Positive Acute Myeloid Leukemia Fred Hutchinson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations M.D. Anderson Cancer Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Gilteritinib-Azacitidine-Venetoclax Combination Therapy in Patients With Relapsed/Refractory Leukemia Florian Kuchenbauer NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS Chaser Therapeutics, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Umbilical Cord Blood Consolidation for Older Adults With Intermediate- and High-Risk AML Shanghai Jiao Tong University School of Medicine NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia BeOne Medicines NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Liposomal Mitoxantrone Plus Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit AML Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer Celgene NA TERMINATED
(Jul 1, 2026)
PHASE2
Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia University of Colorado, Denver NA COMPLETED
(Jul 1, 2026)
PHASE2
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation Johns Hopkins All Children's Hospital NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies National Cancer Institute (NCI) NA COMPLETED
(Jul 1, 2026)
PHASE1
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms University Health Network, Toronto NA RECRUITING
(Jul 1, 2026)
PHASE2
Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia Jonathan Brammer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents Joshua Zeidner NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia St. Jude Children's Research Hospital NA RECRUITING
(Jul 1, 2026)
PHASE1
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant City of Hope Medical Center NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of SA+X in the Treatment of Newly Diagnosed AML Ruijin Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation OHSU Knight Cancer Institute NA RECRUITING
(Jul 1, 2026)
PHASE1
Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms Roswell Park Cancer Institute NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma City of Hope Medical Center NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
New Genotype-guided Treatment in Newly Diagnosed PTCL Ruijin Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML The Second Affiliated Hospital of Kunming Medical University NA RECRUITING
(Jul 1, 2026)
PHASE3
A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients Cullinan Therapeutics Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia Maxinovel Pty., Ltd. NA RECRUITING
(Jul 1, 2026)
PHASE2
The Efficacy of CAPCT in Patients With PTCL The First Affiliated Hospital with Nanjing Medical University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy Astellas Pharma Global Development, Inc. NA COMPLETED
(Jun 1, 2026)
PHASE3
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Dana-Farber Cancer Institute NA RECRUITING
(Jun 1, 2026)
PHASE1
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Institut de Recherches Internationales Servier NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma Celgene NA COMPLETED
(Jun 1, 2026)
PHASE3
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies CellCentric Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy PETHEMA Foundation NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML) AbbVie NA TERMINATED
(Jun 1, 2026)
PHASE3
Study to Evaluate the Safety and Tolerability of EP0042 Ellipses Pharma NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer University of Illinois at Chicago NA RECRUITING
(Jun 1, 2026)
PHASE2
CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) Alice Mims NA RECRUITING
(Jun 1, 2026)
PHASE2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) National Cancer Institute (NCI) NA RECRUITING
(Jun 1, 2026)
PHASE2
Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome Molecular Partners AG NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML) M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1
Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT) Antonio M Jimenez Jimenez NA TERMINATED
(Jun 1, 2026)
PHASE1
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent University of California, Davis NA RECRUITING
(Jun 1, 2026)
PHASE2
VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia. Hematology department of the 920th hospital NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML Dongguan People's Hospital NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations Shen yang NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
VA Consolidation in Intermediate-Risk AML The First Affiliated Hospital of Soochow University NA RECRUITING
(Jun 1, 2026)
PHASE2
Lisaftoclax Plus Azacitidine Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
A Single-Arm, Open Phase I Clinical Study of Selinexor in Combination With Azacitidine for the Treatment of High-Risk AML/MDS Patients After Allo-HSCT Liping Dou NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy AbbVie NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Jacqueline Garcia, MD NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia OncoVerity, Inc. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome AbbVie NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old PETHEMA Foundation NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia Institut de Recherches Internationales Servier NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome Uma Borate NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. Servier Affaires Médicales NA RECRUITING
(May 1, 2026)
PHASE3
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS Apollo Therapeutics Ltd NA RECRUITING
(May 1, 2026)
PHASE1
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy OncoVerity, Inc. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation Institute of Hematology & Blood Diseases Hospital, China NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML Institute of Hematology & Blood Diseases Hospital, China NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML Institute of Hematology & Blood Diseases Hospital, China NA RECRUITING
(May 1, 2026)
PHASE2
HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML Institute of Hematology & Blood Diseases Hospital, China NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS University of Virginia NA RECRUITING
(May 1, 2026)
PHASE1
5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors Mohammed Milhem NA RECRUITING
(May 1, 2026)
PHASE1
tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy Shirley Ryan AbilityLab NA RECRUITING
(May 1, 2026)
PHASE2
Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy Shirley Ryan AbilityLab NA RECRUITING
(May 1, 2026)
PHASE2
A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia The First Affiliated Hospital of Soochow University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
VABu Conditioning in Elderly AML HSCT The First Affiliated Hospital of Soochow University NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy First Affiliated Hospital of Zhejiang University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy First Affiliated Hospital of Zhejiang University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia University Hospital, Bordeaux NA NOT YET RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma M.D. Anderson Cancer Center NA COMPLETED
(Apr 1, 2026)
PHASE2
A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML) BioLite, Inc. NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia St. Jude Children's Research Hospital NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML University of Colorado, Denver NA COMPLETED
(Apr 1, 2026)
PHASE2
Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL The Lymphoma Academic Research Organisation NA COMPLETED
(Apr 1, 2026)
PHASE3
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) Taiho Oncology, Inc. NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia M.D. Anderson Cancer Center NA TERMINATED
(Apr 1, 2026)
PHASE1, PHASE2
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients University of Florence NA COMPLETED
(Apr 1, 2026)
PHASE2
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy. Novartis Pharmaceuticals NA COMPLETED
(Apr 1, 2026)
PHASE1
Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma The First Affiliated Hospital of Soochow University NA RECRUITING
(Apr 1, 2026)
PHASE2
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission Bristol-Myers Squibb NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies Faron Pharmaceuticals Ltd NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy University of Leipzig NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Bristol-Myers Squibb NA RECRUITING
(Apr 1, 2026)
PHASE1
Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia Shanghai Jiao Tong University School of Medicine NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy Justin Watts, MD NA RECRUITING
(Apr 1, 2026)
PHASE2
Imetelstat Combinations in Relapsed AML Douglas Tremblay NA RECRUITING
(Apr 1, 2026)
PHASE1
VAH vs VA in Newly Diagnosed Elderly AML Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL Ruijin Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL). Guangdong Second Provincial General Hospital NA ENROLLING BY INVITATION
(Apr 1, 2026)
PHASE2
Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
SHR2554/AZA + Overlapped TBF for High-risk/Relapsed Leukemia/MDS The First Affiliated Hospital of Soochow University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
SHR2554/AZA + Overlapped Modified BUCY for High-risk/Relapsed Leukemia/MDS The First Affiliated Hospital of Soochow University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary/Elderly AML Ruijin Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders Celgene NA COMPLETED
(Mar 1, 2026)
PHASE2
Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Curis, Inc. NA SUSPENDED
(Mar 1, 2026)
PHASE1, PHASE2
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML Sellas Life Sciences Group NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) Sumitomo Pharma America, Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Venetoclax Basket Trial for High Risk Hematologic Malignancies Andrew E. Place, MD NA RECRUITING
(Mar 1, 2026)
PHASE1
Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients The First Affiliated Hospital of Soochow University NA RECRUITING
(Mar 1, 2026)
PHASE2
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients The First Affiliated Hospital of Soochow University NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome Medical College of Wisconsin NA RECRUITING
(Mar 1, 2026)
PHASE1
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) M.D. Anderson Cancer Center NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients Institut Paoli-Calmettes NA RECRUITING
(Mar 1, 2026)
PHASE2
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients Chinese PLA General Hospital NA RECRUITING
(Mar 1, 2026)
PHASE2
Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker The Methodist Hospital Research Institute NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. French Innovative Leukemia Organisation NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML The First Affiliated Hospital of Soochow University NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3
Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia Shanghai Jiao Tong University School of Medicine NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML M.D. Anderson Cancer Center NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia Chinese PLA General Hospital NA RECRUITING
(Mar 1, 2026)
PHASE2
VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial Beijing 302 Hospital NA RECRUITING
(Mar 1, 2026)
PHASE2
Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia Chinese PLA General Hospital NA RECRUITING
(Mar 1, 2026)
PHASE3




Generic Launch

Generic Release Date:

Onureg's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 03, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Onureg Generic API suppliers:

Azacitidine is the generic name for the brand Onureg. 15 different companies have already filed for the generic of Onureg, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onureg's generic

How can I launch a generic of Onureg before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Onureg's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Onureg's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Onureg -

Strength Submission Date Expiration Date of Last Qualifying Patent 180-Day Status First Applicant Approval Generic Competition Status
25 mg / 5 mL
🔒 Unlock
30 Sep, 2021 03 Jun, 2030 Less






About Onureg

Onureg is a drug owned by Bristol Myers Squibb Co. It is used for continued treatment of adults with acute myeloid leukemia who achieved first complete remission following intensive chemotherapy. Onureg uses Azacitidine as an active ingredient. Onureg was launched by Bristol in 2020.

Approval Date:

Onureg was approved by FDA for market use on 01 September, 2020.

Active Ingredient:

Onureg uses Azacitidine as the active ingredient. Check out other Drugs and Companies using Azacitidine ingredient

Treatment:

Onureg is used for continued treatment of adults with acute myeloid leukemia who achieved first complete remission following intensive chemotherapy.

Dosage:

Onureg is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG TABLET Prescription ORAL
300MG TABLET Prescription ORAL