Lirafugratinib (RLY-4008) Clinical Trials

Size	Price	Qty
5mg	USD 257
25mg	USD 770

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of lirafugratinib (RLY-4008) across Phase 1 and Phase 2 stages in patients with advanced malignancies, including cholangiocarcinoma and FGFR2-altered solid tumors. Industry sponsors Relay Therapeutics Inc. and Elevar Therapeutics are overseeing these investigations, with recruitment statuses ranging from active, not recruiting to actively recruiting. Overall, these studies aim to assess the safety, tolerability, and clinical efficacy of targeted FGFR2 inhibition in molecularly selected patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07359820	RECRUITING	FGFR2 Gene Fusion/Rearrangement; Other Solid Tumors, Adult	Elevar Therapeutics	2026-06-04	PHASE2
NCT04526106	Active not recruiting	FGFR2 Amplification\|FGFR2 Gene Mutation\|FGFR2 Gene Fusion/Rearrangement\|FGFR2 Gene Translocation\|FGFR2 Gene Activation\|Intrahepatic Cholangiocarcinoma\|Cholangiocarcinoma\|Other Solid Tumors Adult	Relay Therapeutics Inc.	2020-09-02	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Lirafugratinib (RLY-4008) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lirafugratinib (RLY-4008) selectively binds to and inhibits fibroblast growth factor receptor 2 (FGFR2), thereby blocking downstream receptor autophosphorylation and oncogenic signaling cascades. This targeted enzymatic inhibition suppresses cellular proliferation and induces apoptosis in cancer cells, providing a rational approach to impair tumor progression in patients with FGFR2-altered cholangiocarcinoma and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).