Navepegritide is a C-type natriuretic peptide analog used in children with achondroplasia to increase linear growth. It is administered by subcutaneous injection. In the United States it was approved for medical use in March 2026.
The FDA approved navepegritide, a once-weekly injectable therapy for achondroplasia, while phase 3 data showed infigratinib, an investigational oral medication, achieved the highest growth velocity reported in randomized trials for the condition.
The FDA has granted accelerated approval for YUVIWEL (navepegritide), the first once-weekly treatment for children with achondroplasia. Commercial availability is expected in early Q2 2026, with a Rare Pediatric Disease Priority Review Voucher granted.
BridgeBio Pharma reported positive Phase 3 results for oral infigratinib in children with achondroplasia, meeting primary and secondary endpoints with superior growth velocity and the first statistically significant improvement in body proportionality. The company plans regulatory submissions in the second half of 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06732895 |
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia. |
RECRUITING | PHASE2 |
| NCT06079398 |
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia |
RECRUITING | PHASE2 |
