Drugs / Navepegritide
Navepegritide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed achondroplasia 2 milestones | |||||
| Filed | US (FDA) | — | achondroplasia | 2025-03-31 | “officially submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Navepegritide” visenpharma.com ↗ |
| Filed | EU (EMA) | — | achondroplasia | — | “TransCon CNP (navepegritide, FDA NDA and EMA MAA filed)” ascendispharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | YUVIWEL | — | 2026-02-27 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT06732895 | Dec 2024 → Aug 2027 expected | achondroplasia | Ascendis Pharma A/S | Recruiting | No outcome recorded |
| Phase 2 | NCT06433557 | Jul 2024 → Nov 2025 overdue | achondroplasia | Ascendis Pharma Growth Disorders A/S | Active not recruiting | Met primary |
| Phase 2 | NCT06079398 | Jan 2024 → Dec 2027 expected | achondroplasia | Ascendis Pharma A/S | Recruiting | No outcome recorded |
| Phase 2 | NCT05246033 | Jan 2022 → Mar 2023 | achondroplasia | Ascendis Pharma A/S | Unknown | No outcome recorded |
| Phase 2 | NCT04085523 | Jun 2020 → Sep 2022 | achondroplasia | Ascendis Pharma A/S | Completed | Met primary |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05929807 | Jun 2023 → Jan 2039 expected | achondroplasia | Ascendis Pharma Growth Disorders A/S | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT05598320 | Mar 2023 → Aug 2024 | achondroplasia | Ascendis Pharma Growth Disorders A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | Ascendis Pharma A/S | Results Ascendis to Share Latest Advances in Hypoparathyroidism and Achondroplasia Programs at ASBMR 2026 ascendispharma.com ↗
Continued Improvements in Lower Extremity Alignment in Navepegritide-Treated Children With Achondroplasia: Week 104 Results from the ApproaCH Trial |
| 2026-09-09 | Ascendis Pharma A/S | Results First Infant Data from Ascendis Trial of Once-Weekly TransCon CNP (Navepegritide) Presented at ESPE 2026 ascendispharma.com ↗
Ascendis Pharma A/S (Nasdaq: ASND) today announced Week 52 data from the open -label sentinel cohort portion of the reACHin Trial (which preceded the now fully enrolled double -blinded portion of the trial ) showing that treatment with once-weekly TransCon CNP (navepegritide) provided stabilization or improvement in foramen magnum stenosis (a skull bone narrowing that can lead to dangerous brain stem and spinal cord compression), as well as linear growth benefits, in infants with achondroplasia aged 0 to <2 years. |
| 2026-08-06 | Ascendis Pharma A/S | Results Ascendis Announces COACH Week 78 Results and Provides Update on Achondroplasia Programs and YUVIWEL® Uptake in the U.S. ascendispharma.com ↗
TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body proportionality, and lower-limb alignment |
| 2026-06-30 | Ascendis Pharma A/S | Results Children with Achondroplasia Treated with TransCon CNP Showed Continued Improvements in Lower Extremity Alignment at Week 104 of the Pivotal ApproaCH Trial ascendispharma.com ↗
In the trial, TransCon CNP-treated children demonstrated continued improvements in lower extremity alignment through up to two years of treatment, including improvements in tibial-femoral angle (TFA). |
| 2026-06-25 | Ascendis Pharma A/S | Results Ascendis to Showcase Advances in Treatment of Achondroplasia at ICCBH 2026 ascendispharma.com ↗
Continued Improvements in Lower Extremity Alignment |
| 2026-05-06 | Ascendis Pharma A/S | Results New 2-Year Data from Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) Show Pronounced Gains in Growth Outcomes in Children with Achondroplasia Aged ≥5 Years ascendispharma.com ↗
New 2-Year Data from Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) Show Pronounced Gains in Growth Outcomes in Children with Achondroplasia Aged ≥5 Years |
| 2026-04-08 | Ascendis Pharma A/S | Results New Data from Week 52 of the Ongoing COACH Trial Showed that TransCon® hGH Accelerated TransCon® CNP’s Benefits Beyond Linear Growth in Children with Achondroplasia ascendispharma.com ↗
Ascendis Pharma A/S (Nasdaq: ASND) today announced new data demonstrating TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth with substantial improvements in arm span, spinal canal dimensions, and lower limb alignment. |
| 2026-04-06 | Ascendis Pharma A/S | Regulatory Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States ascendispharma.com ↗
Ascendis Pharma A/S (Nasdaq: ASND) today announced that YUVIWEL (navepegritide; developed as TransCon® CNP) was granted orphan drug exclusivity by the U.S. Food & Drug Administration (FDA) and that YUVIWEL is now commercially available in the United States. |
| 2026-03-16 | Ascendis Pharma A/S | Results New Two-Year Data from Pivotal ApproaCH Trial Showing Durable Benefits of TransCon® CNP (Navepegritide) in Children with Achondroplasia Shared at ACMG 2026 ascendispharma.com ↗
Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from its pivotal ApproaCH Trial showing that children with achondroplasia treated with once-weekly TransCon CNP (navepegritide) maintained consistent improvements in growth through Week 104, with further improvement in body proportionality during the second year of treatment. |
| 2026-02-27 | Ascendis Pharma A/S | Regulatory FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older ascendispharma.com ↗
FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older |
| 2026-01-08 | Ascendis Pharma A/S | Results Week 52 COACH Trial Topline Results Confirm Consistent and Durable Treatment Benefits in Children with Achondroplasia (ACH) ascendispharma.com ↗
At Week 52, combination therapy showed durable growth without compromising safety or tolerability. |
| 2025-08-15 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results Navepegritide Achieved Primary Efficacy Endpoint with Sustained Clinical Benefits in Chinese Children with Achondroplasia: 104 Weeks Topline Results in ACcomplisH China Phase 2 Trial visenpharma.com ↗
In the trial, children treated with 100μg CNP/kg/week demonstrated significantly higher annualized growth velocity (AGV). |
| 2025-06-03 | Teijin America, Inc. | Regulatory Navepegritide Designated as an Orphan Drug by Japan’s Ministry of Health, Labor and Welfare[Teijin Pharma] teijin.com ↗
Navepegritide Designated as an Orphan Drug by Japan’s Ministry of Health, Labor and Welfare |
| 2025-06-03 | Teijin Pharma Limited | Regulatory 国内臨床試験準備中の「軟骨無形成症」治療薬「TransCon CNP」が厚生労働省より希少疾患用医薬品に指定 teijin-pharma.co.jp ↗ |
| 2025-05-12 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results VISEN Pharmaceuticals Announces the Successful Completion of China Phase 2 Trial of Navepegritide (TransCon CNP) visenpharma.com ↗
Results from the double-blind phase showed that patients dosed with TransCon CNP at the 100 μg CNP/kg/week showed significantly higher annualized growth velocity (AGV) than placebo (1.180 cm/year, P=0.018) at Week 52, with good overall safety and tolerability. |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | navepegritide | “Once-weekly TransCon CNP (navepegritide) in children with achondroplasia” PMID 37823031 ↗ Oct 2023 |
| Known as | Navepegritida | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594507 ↗ |
| Known as | TransCon CNP | “Navepegritide (TransCon CNP) 100 micrograms per kilogram (µg/kg) delivered once weekly by subcutaneous injection” NCT05598320 ↗4“100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly” NCT06079398 ↗ |
| Known as | Transcon cnp-38 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594507 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL4594507 ↗ |
| Route | Subcutaneous | “administered by subcutaneous injection via syringe and needle.” NCT04085523 ↗ |