Drugs / Lirafugratinib
Lirafugratinib
also known as
FGFR2-IN-3 · LIRAFUGRATINIB HYDROCHLORIDE · RLY-4008 · RLY-4008 HCl · RLY-4008 HYDROCHLORIDE
Small molecule targets FGFR2 via inhibition
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04526106 | Sep 2020 → Sep 2025 | intrahepatic cholangiocarcinoma | Elevar Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07359820 | Jun 2026 → Sep 2027 expected | — | Elevar Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2023-10-12 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Initial RLY-4008 (lirafugratinib) Data Demonstrating Durable Responses Across Multiple FGFR2-Altered Solid Tumors relaytx.com ↗
Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced initial clinical data for RLY-4008 (lirafugratinib) in patients with FGFR2-altered solid tumors. |
| 2023-05-25 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Full Dose Escalation Data for RLY-4008 relaytx.com ↗
Five patients experienced a partial response (36% ORR), and six patients experienced a best response of stable disease |
| 2022-09-11 | Relay Therapeutics, Inc. | Results Late Breaking Data Presented at ESMO Congress 2022 Demonstrate Potential of RLY-4008 to Transform Treatment Options for Cholangiocarcinoma Patients with FGFR2-Driven Disease relaytx.com ↗
We believe the interim ORR of 88% for these patients helps to demonstrate the potential power of our Dynamo platform to build transformative therapies for patients. |
| 2022-06-27 | Relay Therapeutics, Inc. | Results Relay Therapeutics Discloses Anticipated Registrational Path for RLY-4008 in Cholangiocarcinoma and Growing Breast Cancer Franchise at Virtual Analyst and Investor Event relaytx.com ↗
End-of-phase 1 meeting with the U.S. Food and Drug Administration (FDA) resulted in alignment on the design of a single arm trial for pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion cholangiocarcinoma (CCA) to potentially support accelerated approval |
| 2021-10-08 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Interim Clinical Data that Support RLY-4008 as a Highly Selective FGFR2 Inhibitor relaytx.com ↗
RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients with three achieving confirmed partial responses |
All press releases naming this drug 13 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lirafugratinib | “Lirafugratinib (RLY-4008), a first-in-class FGFR2-selective inhibitor with activity against resistance-associated FGFR2 kinase domain mutations” PMID 41571046 ↗ Jan 2026 |
| Known as | FGFR2-IN-3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314555 ↗ |
| Known as | LIRAFUGRATINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314555 ↗ |
| Known as | RLY-4008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04526106 ↗ |
| Known as | RLY-4008 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314555 ↗ |
| Known as | RLY-4008 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314555 ↗ |
| Action | Inhibit | “RLY-4008 is an oral inhibitor of FGFR2” NCT04526106 ↗ |
| Modality | Small molecule | — CHEMBL5314555 ↗ |
| Route | Oral | “RLY-4008 is an oral inhibitor of FGFR2” NCT04526106 ↗ |
| Target | FGFR2 | “RLY-4008 is an oral inhibitor of FGFR2” NCT04526106 ↗ |