NDASUBCUTANEOUSPOWDERPriority Review
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
YUVIWEL (navepegritide) by Ascendis Pharma is cnp. First approved in 2026.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YUVIWEL (navepegritide) is a C-type natriuretic peptide (CNP) analog administered subcutaneously as a powder for reconstitution. It treats achondroplasia, the most common form of dwarfism, by inhibiting overactive FGFR3 signaling through NPR-B binding and cGMP pathway activation. The drug promotes chondrocyte differentiation and proliferation to stimulate skeletal bone growth in achondroplasia patients.
Growth16.4 years to LOE
As a newly launched first-in-class therapy for a rare genetic disorder, YUVIWEL will require a highly specialized commercial team focused on rare disease pediatric networks and genetic counselors.
Mechanism of Action
CNP. CNP binds to natriuretic peptide receptor-B (NPR-B), which inhibits the mitogen activated protein kinase signaling (MAPK) pathway. Achondroplasia is caused by a gain-of-function variant in the fibroblast growth factor receptor 3 (FGFR3) leading to overactive downstream signaling. The overly…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.
Started Dec 2024
24 enrolled
Achondroplasia
A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia
Started Jul 2024
22 enrolled
Achondroplasia
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia
Started Jan 2024
72 enrolled
Achondroplasia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.