Drugs / TransCon PTH
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | hypoparathyroidism | 2024-12-13 | “Teijin Pharma Limited announced today that it has applied for manufacturing and marketing approval in Japan for palopegteriparatide” teijin.com ↗ |
| Filed | EU (EMA) | — | hypoparathyroidism | — | “Ascendis Pharma also submitted a Marketing Authorization Application (MAA) for palopegteriparatide for adult patients with HP to the European Medicines Agency (EMA)” visenpharma.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT04009291 | Aug 2019 → Mar 2020 | hypoparathyroidism | Ascendis Pharma A/S | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05387070 | Jul 2021 → Jan 2023 | hypoparathyroidism | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-06-13 | Ascendis Pharma A/S | Results Phase 3 Data Show TransCon® PTH Replicated Systemic Actions of Endogenous PTH Through Week 182 in Adults with Hypoparathyroidism ascendispharma.com ↗ |
| 2026-06-11 | Ascendis Pharma A/S | Results 5-Year Phase 2 Data Show TransCon® PTH Replicated Systemic Actions of Endogenous PTH in Adults with Hypoparathyroidism ascendispharma.com ↗
Ascendis Pharma A/S (Nasdaq: ASND) today announced 5-year (Week 266) data from its Phase 2 PaTH Forward Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) demonstrated sustained efficacy and safety in adults with hypoparathyroidism. |
| 2025-09-23 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory VISEN Launches Palopegteriparatide in China's Hainan Boao Pilot Zone as the First and Only Hormone Replacement Therapy for Hypoparathyroidism visenpharma.com ↗
today announced that palopegteriparatide (TransCon PTH) has been approved by the Hainan Medical Products Administration for clinical use 1 for the treatment of adult chronic hypoparathyroidism (HP). |
| 2024-12-13 | Teijin America, Inc. | Regulatory Teijin Pharma Limited Applies for Manufacturing and Marketing Approval in Japan for New Hypoparathyroidism Treatment[Teijin Pharma] teijin.com ↗
Teijin Pharma Limited announced today that it has applied for manufacturing and marketing approval in Japan for palopegteriparatide (developed as TransCon PTH ), a new prodrug developed by Ascendis Pharma A/S (Nasdaq: ASND) for the treatment of adults with hypoparathyroidism. |
| 2024-08-09 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Results VISEN Pharmaceuticals Announced that Phase 3 PaTHway China Trial of Palopegteriparatide Achieved Primary and Key Secondary Endpoints in the Treatment of Adults with Hypoparathyroidism visenpharma.com ↗
VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, today announced topline data from the 26-week randomized, double-blind, placebo-controlled portion of the Phase 3 PaTHway China Trial of Palopegteriparatide (TransCon PTH) in adults with chronic hypoparathyroidism. |
| 2021-06-04 | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Regulatory The first hormone replacement therapy for hypoparathyroidism in China obtains IND approval for Phase III clinical trial visenpharma.com ↗
VISEN Pharmaceuticals has obtained the investigational new drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the phase III China clinical trial (PaTHway China Trial) of TransCon PTH Solution for Injection (TransCon™ parathyroid hormone). |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TransCon PTH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04009291 ↗ |
| Known as | palopegteriparatide | “investigational drug TransCon PTH (palopegteriparatide).” PMID 36271471 ↗ Nov 2022 |
| Route | Subcutaneous | “TransCon PTH 15 mcg delivered once daily by subcutaneous injection” NCT04009291 ↗ |