Drugs / Lonapegsomatropin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pituitary deficiency 1 milestone | |||||
| Filed | US (FDA) | — | pituitary deficiency | 2026-01-09 | “Biologic License Application (BLA) for TransCon hGH (lonapegsomatropin) as a potential treatment for pediatric growth hormone deficiency (PGHD) was accepted” ascendispharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Filed | Japan (PMDA) | — | — | 2026-02-12 | “Teijin Pharma Limited announced today that it has applied for manufacturing and marketing approval in Japan for lonapegsomatropin” teijin.com ↗ |
| Approved | EU (EMA) | Skytrofa (previously Lonapegsomatropin Ascendis Pharma) | — | 2022-01-11 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06433557 | Jul 2024 → Nov 2025 overdue | achondroplasia | Ascendis Pharma Growth Disorders A/S | Active not recruiting | Met primary |
| Phase 2 | NCT05690386 | Feb 2023 → Oct 2024 overdue | Turner syndrome | Ascendis Pharma Endocrinology Division A/S | Active not recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07221851 | Dec 2025 → Feb 2028 expected | SHOX-related short stature, Turner syndrome, fetal growth restriction, isolated short stature | Ascendis Pharma A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05171855 | Dec 2021 → Dec 2024 | pituitary deficiency | Ascendis Pharma Endocrinology Division A/S | Completed | No outcome recorded |
| Phase 3 | NCT04615273 | Dec 2020 → Nov 2023 | pituitary deficiency | Ascendis Pharma Endocrinology Division A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 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 and TransCon hGH combination therapy Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increase in healthy, proportional growth |
| 2026-06-25 | Ascendis Pharma A/S | Results Ascendis to Showcase Advances in Treatment of Achondroplasia at ICCBH 2026 ascendispharma.com ↗
These follow-up data reinforce the unique benefits of TransCon CNP alone and in combination with TransCon hGH |
| 2026-04-21 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results China's briGHt Trial Published in Hormone Research in Paediatrics Further Confirms Once-Weekly Lonapegsomatropin as the Only Long-Acting Growth Hormone with Demonstrated Superiority Over Daily Somatropin visenpharma.com ↗
The trial showed that weekly lonapegsomatropin demonstrated non-inferiority and superiority over daily somatropin in annualized height velocity (AHV) among treatment-naive Chinese children with GHD. |
| 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. |
| 2026-03-17 | Ascendis Pharma A/S | Results New InsiGHTS Trial of TransCon® hGH (Lonapegsomatropin) in Turner Syndrome Demonstrated Comparable Efficacy and Safety to Daily Somatropin at Week 52 ascendispharma.com ↗
New InsiGHTS Trial of TransCon® hGH (Lonapegsomatropin) in Turner Syndrome Demonstrated Comparable Efficacy and Safety to Daily Somatropin at Week 52 |
| 2026-02-12 | Teijin America, Inc. | Regulatory Teijin Pharma Limited Applies for Manufacturing and Marketing Approval in Japan for New Weekly Pediatric Growth Hormone Deficiency Treatment[Teijin Pharma] teijin.com ↗
Teijin Pharma Limited announced today that it has applied for manufacturing and marketing approval in Japan for lonapegsomatropin, a prodrug of somatropin that is administered once weekly, developed as TransCon hGH by Ascendis Pharma A/S (Nasdaq: ASND). |
| 2026-01-26 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory VISEN Receives China NMPA Approval for Once-Weekly Lonapegsomatropin for Pediatric Growth Hormone Deficiency visenpharma.com ↗
VISEN Pharmaceuticals (2561.HK), an innovative biopharmaceutical company focused on endocrine diseases, today announces that its core product, lonapegsomatropin, has been officially approved by the China National Medical Products Administration (NMPA) for the treatment of pediatric growth hormone deficiency (PGHD). |
| 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. |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lonapegsomatropin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07221851 ↗ |
| Known as | SKYTROFA | “Lonapegsomatropin [SKYTROFA®]” NCT07221851 ↗ |
| Modality | Protein / enzyme biologic | “a long-acting growth hormone product” NCT05690386 ↗ |
| Route | Subcutaneous | “Lonapegsomatropin administered once-weekly by subcutaneous injection.” NCT04615273 ↗ |