Drugs / ABSK061
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07007546 | May → Jul 2025 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05244551 | Jun 2022 → Apr 2025 overdue | cancer | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07297875 | Dec 2025 → Dec 2028 expected | achondroplasia | Abbisko Therapeutics Co, Ltd | Not yet recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06632262 | Nov 2024 → Nov 2029 expected | gastroesophageal cancer, non-small cell lung carcinoma, urothelial carcinoma | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Announces Positive Preliminary Phase 2 Results with Lavengratinib (ABSK061) for the Treatment of Achondroplasia abbisko.com ↗
At Week 27, the seven participants in the first and lowest dose cohort (0.064 mg/kg, once daily) achieved a mean improvement of +2.4 cm/year in AHV from baseline, with a responder rate* of 100%. |
| 2026-06-26 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Reports Phase II Data of ABSK061 in Combination with ABSK043 in FGFR2-Positive Advanced GC/GEJC Presented at ASCO 2026 abbisko.com ↗
The study demonstrated a favorable safety profile and promising anti-tumor activity of ABSK061 plus ABSK043, with or without CAPOX, in patients with FGFR2-positive advanced GC/GEJC |
| 2026-04-23 | Abbisko Therapeutics Co, Ltd | Results AACR 2026 | Abbisko Therapeutics Showcases Six Research Advances Highlighting pan-KRAS, 4th Generation EGFR, and Synthetic Lethality Approaches abbisko.com ↗ |
| 2026-03-31 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics' FGFR2/3 Inhibitor ABSK061 Receives FDA IND Clearance for Achondroplasia in Children abbisko.com ↗ |
| 2026-03-19 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics' FGFR2/3 Inhibitor ABSK061 Granted Orphan Drug Designation by FDA for Achondroplasia abbisko.com ↗
ABSK061, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of achondroplasia (ACH). |
| 2026-03-11 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces FDA Rare Pediatric Disease Designation for FGFR2/3 Inhibitor ABSK061 abbisko.com ↗ |
| 2025-03-26 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces IND Clearance from the CDE for ABSK061, a Highly Selective FGFR2/3 Inhibitor, for the Treatment of Achondroplasia abbisko.com ↗ |
| 2024-02-28 | Abbisko Therapeutics Co, Ltd | Results 2024 ESMO TAT Oral Presentation — Abbisko Therapeutics presented preliminary first-in-human trial results of its selective FGFR2/3 inhibitor ABSK061 abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics) presented the preliminary first-in-human results of its next-generation highly selective FGFR2/3 inhibitor ABSK061 in patients with advanced solid tumors during the 2024 European Society for Medical Oncology Targeted Anticancer Therapies Congress (ESMO TAT). |
| 2022-03-03 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Has Obtained IND Approval for ABSK061, an Innovative and Highly Selective FGFR2/3 Inhibitor, from the NMPA abbisko.com ↗
ABSK061 has also become the first selective, small-molecule FGFR2/3 inhibitor approved by the FDA and the NMPA for clinical trial worldwide. |
| 2021-10-25 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtained Clinical Trial Approval for ABSK061, A Selective Inhibitor of FGFR2 and FGFR3, by the U.S. FDA abbisko.com ↗
We are very pleased to receive the regulatory approval of ABSK061 in the U.S., which is a critical first step for our following clinical trials. |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABSK061 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07007546 ↗ |
| Action | Inhibit | “ABSK061 is a selective and potent pan FGFR 2/3 inhibitor” NCT06632262 ↗ |
| Route | Oral | “oral ABSK061” NCT05244551 ↗ |