Drugs / irpagratinib
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07010497 | Mar 2026 → Mar 2029 expected | hepatocellular carcinoma | Asan Medical Center | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-04-01 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics' FGFR4 Inhibitor Irpagratinib Granted Orphan Drug Designation by EMA for Hepatocellular Carcinoma abbisko.com ↗ |
| 2026-02-10 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics' FGFR4 Inhibitor Irpagratinib Granted FDA Fast Track Designation for Advanced HCC Patients with FGF19 Overexpression Previously Treated with ICIs and mTKIs Therapies abbisko.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to irpagratinib (ABSK-011) |
| 2025-06-26 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics to Present Updated Results from the Phase 2 Study of Irpagratinib in Combination with Atezolizumab for the Treatment of Advanced Hepatocellular Carcinoma at the 2025 ESMO GI Congress abbisko.com ↗
At the 2025 ESMO GI Congress, Abbisko Therapeutics unveiled updated clinical trial results for the combination of irpagratinib and atezolizumab in patients with FGF19 overexpression hepatocellular carcinoma (HCC). |
| 2025-05-26 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC abbisko.com ↗
May 26, 2025 — Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC). |
| 2024-12-17 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Receives CDE Approval to Initiate a Registrational Study of Irpagratinib (ABSK011) in patients with Hepatocellular Carcinoma abbisko.com ↗
Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a registrational clinical trial for the treatment of Hepatocellular Carcinoma (HCC). |
| 2024-09-19 | Abbisko Therapeutics Co, Ltd | Results Abbisko awarded Best Poster Award at ESMO Congress 2024 abbisko.com ↗
The update data from irpagratinib study showed a tolerable safety profile and promising anti-tumor activity of Irpagratinib monotherapy in aHCC. |
| 2024-09-18 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Presents Updated Clinical Progress on Irpagratinib and Pimicotinib at European Society for Medical Oncology (ESMO) 2024 abbisko.com ↗
ABSK-011, a potent FGFR4 inhibitor, demonstrated a tolerable safety profile and promising anti-tumor activity as a single agent. |
| 2024-06-28 | Abbisko Therapeutics Co, Ltd | Results 2024 ESMO-GI | Abbisko Therapeutics presents new phase II clinical data of irpagratinib in combination with atezolizumab for advanced hepatocellular carcinoma abbisko.com ↗
The presentation highlights that 220mg BID of irpagratinib in combination with atezolizumab demonstrated promising antitumor activity with an objective response rate (ORR) of 50% in FGF19+ HCC patients. |
| 2024-04-25 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces Irpagratinib, an Innovative FGFR4 inhibitor,has been Granted ODD by the U.S. FDA for the Treatment of HCC abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (referred to as “Abbisko Therapeutics” hereafter) announced that its innovative FGFR4 inhibitor, irpagratinib, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular Carcinoma (HCC). |
| 2024-04-10 | Abbisko Therapeutics Co, Ltd | Results 2024 AACR | Abbisko Therapeutics Presented 3 Pre-clinical Research Results with Oral and Poster Presentations abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics) announced that it has presented the pre-clinical combination study results of its highly selective FGFR4 inhibitor Irpagratinib (ABSK011) with oral presentation during AACR 2024. |
| 2024-03-07 | Abbisko Therapeutics Co, Ltd | Results 2024 AACR | Abbisko Therapeutics will present 3 pre-clinical research results with oral presentation and posters abbisko.com ↗
Selective FGFR4 inhibitor Irpagratinib (ABSK011) exhibits broad synergistic and combinatory anti-tumor effects with other therapeutic agents in preclinical HCC models |
| 2023-10-17 | Abbisko Therapeutics Co, Ltd | Results Abbisko will debut two blockbuster clinical research results at the 2023 European Society for Medical Oncology（ESMO） abbisko.com ↗
The Irpagratinib BID cohorts demonstrated a promising antitumor activity with an ORR of 40.7% in FGF19+ HCC pts with prior therapies. |
| 2023-09-25 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtains Approval from U.S. FDA to Conduct Phase I Clinical Study of FGFR4 Inhibitor Irpagratinib (ABSK011) abbisko.com ↗
The approved study is “A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumors”. |
| 2022-12-15 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics announces preliminary Phase I safety and efficacy results of Irpagratinib (ABSK011) in patients in second-line hepatocellular carcinoma with FGF19 overexpression abbisko.com ↗
Preliminary efficacy and safety data for 42 HCC patients, out of which 27 patients are FGF19 IHC+, has been analyzed as of September 2022. |
All press releases naming this drug 23 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | irpagratinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07010497 ↗ |
| Known as | ABSK-011 | “ABSK-011 (irpagratinib)” NCT07010497 ↗ |
| Modality | Small molecule | — CHEMBL5314522 ↗ |
| Route | Oral | “Patients will receive oral administration of ABSK-011 capsules” NCT07010497 ↗ |