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Recent FDA approvals and tentative approvals for Ascend

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


Generic drugs

Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.

Drug Name Submission class (FDA) Submission Category Submission Date
Eluxadoline ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 17 Dec, 2021


Clinical Trials

Recent Clinical Trials by Ascend:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia Ascendis Pharma Growth Disorders A/S NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE2, PHASE3
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism Ascendis Pharma Bone Diseases A/S NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism Ascendis Pharma A/S NA RECRUITING
(Jul 1, 2026)
PHASE3
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia Ascendis Pharma A/S NA COMPLETED
(Jun 1, 2026)
PHASE2
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia Ascendis Pharma Growth Disorders A/S NA COMPLETED
(Jun 1, 2026)
PHASE2, PHASE3
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia Ascendis Pharma A/S NA RECRUITING
(Apr 1, 2026)
PHASE2
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia. Ascendis Pharma A/S NA RECRUITING
(Apr 1, 2026)
PHASE2


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