Drugs / Palopegteriparatide
Palopegteriparatide
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypoparathyroidism 2 milestones | |||||
| Filed | Japan (PMDA) | — | hypoparathyroidism | 2024-12-13 | “applied for manufacturing and marketing approval in Japan for palopegteriparatide (developed as TransCon PTH )” teijin.com ↗ |
| Filed | EU (EMA) | — | hypoparathyroidism | 2023-01-06 | “Ascendis Pharma also submitted a Marketing Authorization Application (MAA) for palopegteriparatide for adult patients with HP to the European Medicines Agency (EMA).” visenpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | YORVIPATH | — | 2024-08-09 | fda.gov ↗ |
| Approved | EU (EMA) | Yorvipath | — | 2023-11-17 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07706764 | Apr 2026 → Aug 2027 expected | hypoparathyroidism | Ascendis Pharma A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT07081997 | Apr 2026 → Jun 2027 expected | hypoparathyroidism | Ascendis Pharma Bone Diseases A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT04701203 | Feb 2021 → Jan 2022 | hypoparathyroidism | Ascendis Pharma Bone Diseases A/S | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05654701 | — | hypoparathyroidism | Ascendis Pharma Bone Diseases A/S | Approved for marketing | No outcome recorded |
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). |
| 2025-08-25 | Teijin America, Inc. | Regulatory Teijin Pharma Receives Manufacturing and Marketing Approval in Japan for YORVIPATH® as the Treatment for Hypoparathyroidism[Teijin Pharma] teijin.com ↗
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced today that it has received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for YORVIPATH® |
| 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. |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | palopegteriparatide | “This study looked at how a new treatment for chronic hypoparathyroidism, palopegteriparatide (approved in the European Union under the brand name YORVIPATH®), affects kidney...” PMID 38691316 ↗ Apr 2024 |
| Known as | TransCon PTH | “This study's purpose was to understand the impacts of the phase 3 PaTHway clinical trial treatment, TransCon PTH, on patients' overall, physical, and cognitive...” PMID 39136801 ↗ Aug 20241“The investigational drug Palopegteriparatide (TransCon PTH) is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended...” NCT05654701 ↗ |
| Known as | YORVIPATH | “This study looked at how a new treatment for chronic hypoparathyroidism, palopegteriparatide (approved in the European Union under the brand name YORVIPATH®), affects kidney...” PMID 38691316 ↗ Apr 2024 |
| Route | Subcutaneous | “TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen.” NCT04701203 ↗ |