Drugs / ABSK-011
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07700953 | Jul → Aug 2026 overdue | — | Abbisko Therapeutics Co, Ltd | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06896760 | Apr → Nov 2025 overdue | — | Abbisko Therapeutics Co, Ltd | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06306872 | Feb 2024 → Sep 2025 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04906434 | Feb 2020 → Dec 2027 expected | liver cancer | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07327034 | Jun 2025 → Jun 2027 expected | hepatocellular carcinoma | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT06978933 | Apr 2025 → Dec 2026 expected | hepatocellular carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05441475 | Dec 2021 → Dec 2028 expected | hepatocellular carcinoma | Abbisko Therapeutics Co, Ltd | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| 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 ↗
The treatment combination with irpagratinib showcases an objective response rate (ORR) of ≥50% and a median progression-free survival (PFS) of ≥7 months. |
| 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). |
| 2025-05-13 | 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 ↗
The oral presentation will highlight the regimen’s favorable safety and promising anti-tumor activity in both treatment-naive and previously treated FGF19+ HCC patients. |
| 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 ↗ |
| 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 ↗ |
| 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 ↗
BID cohorts demonstrated a promising antitumor activity with an ORR of 40.7% in FGF19+ HCC pts with prior therapies, which suggests that ABSK-011 may have clinical benefit through biomarker selection of FGF19. |
| 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 ↗ |
| 2020-03-09 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces Receiving of the IND Approval by the China NMPA for ABSK-011, A Novel FGFR4 Inhibitor abbisko.com ↗
ABSK-011 is the first program of Abbisko Therapeutics to be approved for clinical studies in China. |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABSK-011 | “Participants will receive a single oral administration of approximately 200 mg/120 µCi \[14C\]ABSK-011 suspension after a low-fat breakfast on day 1 morning.” NCT06896760 ↗ |
| Action | Inhibit | “selective FGFR4 inhibitor” NCT06978933 ↗ |
| Route | Oral | “administration of oral ABSK-011” NCT04906434 ↗ |
| Target | FGFR4 | “selective FGFR4 inhibitor” NCT06978933 ↗ |