Drugs / TransCon hGH
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | pituitary deficiency | 2024-03-08 | “today announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA).” visenpharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04326374 | Dec 2019 → Apr 2022 | anterior pituitary gland disorder, pituitary deficiency | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03344458 | Dec 2017 → Feb 2023 | pituitary deficiency, pituitary gland disorder | Ascendis Pharma A/S | Completed | No outcome recorded |
| Phase 3 | NCT03305016 | Nov 2017 → Mar 2019 | pituitary deficiency, pituitary gland disorder | Ascendis Pharma Endocrinology Division A/S | Completed | No outcome recorded |
| Phase 3 | NCT02781727 | Dec 2016 → Jan 2019 | pituitary deficiency | Ascendis Pharma Endocrinology Division A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| 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. |
| 2024-03-08 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory VISEN Announced Acceptance of a Biologics License Application for Lonapegsomatropin in China visenpharma.com ↗
VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, today announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA). |
| 2022-11-17 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results VISEN Discloses 52-week Clinical Results for Its China Phase 3 Trial of Lonapegsomatropin Currently the Only Long-Acting Growth Hormone Demonstrates Superior Annualized Height Velocity Compared to Daily hGH in Children with Growth Hormone Deficiency visenpharma.com ↗
The AHV was significantly higher for lonapegsomatropin than for the daily hGH from week 13 onward. |
| 2022-05-23 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results VISEN Pharmaceuticals Announces Top-line Results of Phase 3 Trial of Once-Weekly Lonapegsomatropin, Demonstrating Superior Efficacy, Comparable Safety and Tolerability to Daily Growth Hormone visenpharma.com ↗
The trial met its primary objective, demonstrating that lonapegsomatropin was observed to be non-inferior and, additionally, superior to the daily growth hormone on the primary endpoint of annualized height velocity (AHV) at 52 weeks. |
| 2020-06-30 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory VISEN Pharma: TransCon TM hGH Biologics License Application (BLA) to United States FDA was submitted visenpharma.com ↗
announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on June 26 th 2020, for TransCon TM hGH |
| 2020-04-21 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory TransCon TM hGH Received Orphan Drug Designation in the US and EC as Treatment for Growth Hormone Deficiency visenpharma.com ↗
On Apr 15, 2020, Ascendis Pharma A/S (Nasdaq: ASND) announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to TransCon TM hGH (lonapegsomatropin), as a treatment for growth hormone deficiency (GHD). |
All press releases naming this drug 15 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 | TransCon hGH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02781727 ↗ |
| Known as | lonapegsomatropin | “Lonapegsomatropin (TransCon hGH) is an investigational long-acting, once-weekly prodrug for the treatment of GHD.” PMID 34272849 ↗ Oct 2021 |
| Modality | Protein / enzyme biologic | “TransCon hGH, a long-acting growth hormone product” NCT02781727 ↗ |
| Route | Subcutaneous | “Once weekly subcutaneous injection of TransCon hGH” NCT02781727 ↗ |