navepegritide
navepegritide: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.
navepegritide evidence translation
What we can confirm
1 FDA record · 3 tracked trials
What it means
What to watch
Prepared research question
How could navepegritide → ASND affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Ascendis Pharma A/S (ASND) Reported 2026-02-27 · Current development: unknownSource | Phase 2/Phase 3 |
Clinical Trial Registry Records (3)
A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of Navepegritide Administered Once Weekly for 52 Weeks in Adolescents (12-18 Years of Age) With Achondroplasia.
Primary endpoint: Annualized Growth Velocity
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial, Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Infants (0 to <2 Years of Age) With Achondroplasia Followed by an Open Label Extension (OLE) Period
Primary endpoint: To evaluate the safety and tolerability of Navepegritide
A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children With Achondroplasia Followed by an Open Label Extension Period
Primary endpoint: Annualized Growth Velocity (AGV) at Week 52
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with navepegritide?
navepegritide has dated SEC/FDA relationship records for Ascendis Pharma A/S.
How many clinical trials involve navepegritide?
BioSniper tracks 3 clinical trials involving navepegritide.
What is navepegritide's latest FDA decision?
The most recent tracked FDA decision for navepegritide is Approval for 1 INDICATIONS AND USAGE YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velocity . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 ), dated February 27, 2026.