Irpagratinib clinical trials
Also written ABSK-011.
How each study uses irpagratinib is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
Studies by the year they started
7 studies that test it; most in 2025 (3)
| Year | Studies |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 3 |
| 2026 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 5 · Other 2
Abbisko Therapeutics Co, Ltd (5) · Asan Medical Center (1) · RenJi Hospital (1)
Related medicines
As reviewed, each with the page that says it.
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 2
Studies that test irpagratinib.
- Dec 2026FGF19 Overexpression Combination Unified Study in HCC-19Phase 2 · RenJi Hospital
- Jun 2027ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 OverexpressionPhase 2 · Abbisko Therapeutics Co, Ltd
Studies
Open first, then newest update. How each study uses irpagratinib is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 7
- A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy ParticipantsRecruitingPhase 1Abbisko Therapeutics Co, LtdNCT07700953Written as ABSK-011 Capsules
- A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular CarcinomaRecruitingPhase 2Asan Medical CenterNCT07010497Written as irpagratinib
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid TumorRecruitingPhase 1Abbisko Therapeutics Co, LtdNCT04906434Written as ABSK-011
- A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC PatientsEnrolling by invitationPhase 2Abbisko Therapeutics Co, LtdNCT05441475Written as ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w
- ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 OverexpressionRecruitingPhase 2Abbisko Therapeutics Co, LtdNCT07327034Written as ABSK-011+BSC
- FGF19 Overexpression Combination Unified Study in HCC-19RecruitingPhase 2RenJi HospitalNCT06978933Written as ABSK-011
- A Mass Balance Study of [14C]ABSK011Not yet recruitingPhase 1Abbisko Therapeutics Co, LtdNCT06896760Written as [14C]ABSK011
Codes
What other systems call irpagratinib · ClinicalTrials.gg INT018425
- UNII (FDA) X46B7JM4A8IRPAGRATINIBOne source FDA
- NCI Thesaurus C189047IrpagratinibOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| UNII (FDA) | X46B7JM4A8 | IRPAGRATINIB | One source FDA |
| NCI Thesaurus | C189047 | Irpagratinib | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.