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  1. pharmadog
  2. ›drugs
  3. ›Yuviwel
drug
save

navepegritide

Marketedupdated 5mo ago
by Ascendis Pharma AS
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • drugYUVIWEL4 co-mentions · 1 sources
  • tagApproval4 co-mentions · 1 sources

all catalysts(1)

approval · 1
Feb 27, 2026
approval
7mo ago
YUVIWEL (NAVEPEGRITIDE) — FDA approval
navepegritide
→

Trials studying navepegritide

  • phase3A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasiacompletedn=84
  • phase2A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.recruitingn=24
  • phase2A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasiarecruitingn=72
  • phase2A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasiaactive not recruitingn=22

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 30, 2031
~4.6 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (36)

  • Nov 12, 2042formulationUS 12377133
  • Nov 12, 2042formulationUS 12377133
  • Nov 12, 2042formulationUS 12377133
  • Jan 5, 2037compositionUS 10835578
  • Jan 5, 2037compositionUS 10835578
  • Jan 5, 2037compositionUS 10835578
  • Jan 5, 2037compositionUS 11154593
  • Jan 5, 2037compositionUS 11154593
  • Jan 5, 2037compositionUS 11154593
  • Jan 5, 2037compositionUS 11224661
  • Jan 5, 2037compositionUS 11224661
  • Jan 5, 2037compositionUS 11224661
  • Jan 5, 2037compositionUS 11311604
  • Jan 5, 2037compositionUS 11311604
  • Jan 5, 2037compositionUS 11311604
  • Jan 5, 2037compositionUS 11389510
  • Jan 5, 2037compositionUS 11389510
  • Jan 5, 2037compositionUS 11389510
  • Jan 5, 2037formulationUS 11389511
  • Jan 5, 2037formulationUS 11389511
  • Jan 5, 2037formulationUS 11389511
  • Jan 5, 2037compositionUS 11413351
  • Jan 5, 2037compositionUS 11413351
  • Jan 5, 2037compositionUS 11413351
  • Jan 5, 2037method-of-use (U-4425)US 12083182
  • Jan 5, 2037method-of-use (U-4425)US 12083182
  • Jan 5, 2037method-of-use (U-4425)US 12083182
  • Jan 5, 2037method-of-use (U-4425)US 12156917
  • Jan 5, 2037method-of-use (U-4425)US 12156917
  • Jan 5, 2037method-of-use (U-4425)US 12156917
  • Jan 5, 2037method-of-use (U-4425)US 12239689
  • Jan 5, 2037method-of-use (U-4425)US 12239689
  • Jan 5, 2037method-of-use (U-4425)US 12239689
  • Apr 30, 2031compositionUS 89068474.6y
  • Apr 30, 2031compositionUS 89068474.6y
  • Apr 30, 2031compositionUS 89068474.6y

FDA exclusivities (3)

  • Feb 27, 2033ODE-516Orphan Drug (7y)
  • Feb 27, 2033ODE-516Orphan Drug (7y)
  • Feb 27, 2033ODE-516Orphan Drug (7y)

News(5)

  • 5 biotechs braving the commercial waters with product launches
    A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
    biospace · 17d ago
  • Novo walks away from $285M pact to develop monthly GLP-1 obesity drug with Ascendis
    Novo’s attempted rebrand got off to a shaky start this week with the news that the pharma had walked away from a $285 million biobucks pact to develop a monthly weight loss drug after less than two…
    fiercebiotech · 18d ago
  • Teva claims success in celiac study; BioMarin, Ascendis settle patent dispute
    Teva believes the therapy has “pipeline-in-a-product” potential. Elsewhere, a high-stakes trial was paused and GSK advanced a competitor to Moderna’s flu shot.
    biopharma_dive · 1mo ago
  • Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
    Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 1…
    biospace · 1mo ago
  • BioMarin axes asset from $270M Inozyme takeover, ending run in rare metabolic indication
    BioMarin’s discontinued drug showed biomarker benefits in a Phase 3 study for ENPP1 deficiency but these failed to translate to clinical improvements.
    biospace · 1mo ago
brand
Yuviwel
generic
navepegritide
indication
Achondroplasia
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 16m ago
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