Drugs / HMPL-453
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07697157 | Mar → Dec 2025 | — | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT07644442 | Feb → Mar 2025 | — | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05930119 | Mar → Aug 2023 | intrahepatic cholangiocarcinoma | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT02966171 | Jan 2017 → Aug 2018 | cancer | Hutchison Medipharma Limited | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05173142 | Jan 2022 → Jul 2025 | neoplasm | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT03160833 | May 2017 → Dec 2019 | cancer | Hutchison Medipharma Limited | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04290325 | Dec 2019 → Nov 2022 | malignant mesothelioma | Hutchison Medipharma Limited | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04353375 | Sep 2020 → Jun 2028 expected | intrahepatic cholangiocarcinoma | Hutchmed | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma hutch-med.com ↗
today announces that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration (“NMPA”) |
| 2026-06-25 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026 hutch-med.com ↗
The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. |
| 2025-12-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma hutch-med.com ↗ |
All press releases naming this drug 10 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 | HMPL-453 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07697157 ↗ |
| Action | Inhibit | “Fibroblast growth factor receptor 3 inhibitor” CHEMBL4650297 ↗3“Fibroblast growth factor receptor 1 inhibitor” CHEMBL4650297 ↗ “Fibroblast growth factor receptor 2 inhibitor” CHEMBL4650297 ↗ “FGFR Inhibitor” NCT07644442 ↗ |
| Route | Oral | “oral administration” NCT02966171 ↗ |
| Target | FGFR1 | “Fibroblast growth factor receptor 1 inhibitor” CHEMBL4650297 ↗ |
| Target | FGFR2 | “Fibroblast growth factor receptor 2 inhibitor” CHEMBL4650297 ↗ |
| Target | FGFR3 | “Fibroblast growth factor receptor 3 inhibitor” CHEMBL4650297 ↗ |