Infigratinib Phosphate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Infigratinib Phosphate is being evaluated across numerous clinical trials spanning Early Phase 1 through Phase 3 for therapeutic applications in oncology and skeletal dysplasias, including advanced cholangiocarcinoma, urothelial carcinoma, gastric cancer, achondroplasia, and hypochondroplasia. Sponsored by pharmaceutical entities such as QED Therapeutics and LianBio LLC alongside academic institutions including M.D. Anderson Cancer Center and Emory University, trial recruitment statuses currently range from recruiting and enrolling by invitation to completed, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07393373	ENROLLING_BY_INVITATION	Hypochondroplasia	QED Therapeutics, a BridgeBio company	2026-04-23	PHASE2
NCT05145010	ENROLLING_BY_INVITATION	Achondroplasia	QED Therapeutics, a BridgeBio company	2021-12-06	PHASE2
NCT07169279	RECRUITING	Achondroplasia	QED Therapeutics, a BridgeBio company	2025-11-19	PHASE2
NCT06926491	RECRUITING	Achondroplasia	Kyowa Kirin Co., Ltd.	2024-12-01	PHASE3
NCT05514912	WITHDRAWN	Resectable Intrahepatic Cholangiocarcinoma; Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8; Stage I Intrahepatic Cholangiocarcinoma AJCC v8; Stage II Intrahepatic Cholangiocarcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8	Emory University	2024-03-01	PHASE2
NCT06873035	ENROLLING_BY_INVITATION	Hypochondroplasia	QED Therapeutics, a BridgeBio company	2025-04-22	PHASE2; PHASE3
NCT06164951	COMPLETED	Achondroplasia	QED Therapeutics, a BridgeBio company	2023-11-10	PHASE3
NCT04265651	COMPLETED	Achondroplasia	QED Therapeutics, a BridgeBio company	2020-03-10	PHASE2
NCT06206278	TERMINATED	Gastric Cancer; Gastroesophageal Junction Adenocarcinoma	LianBio LLC	2023-10-19	PHASE2
NCT04228042	TERMINATED	Renal Pelvis and Ureter Urothelial Carcinoma	M.D. Anderson Cancer Center	2020-07-28	PHASE1; PHASE2
NCT04233567	COMPLETED	Advanced Malignant Solid Neoplasm; Cholangiocarcinoma; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm	Sameek Roychowdhury	2020-01-16	PHASE2
NCT05510427	WITHDRAWN	Cholangiocarcinoma; Liver Cancer	M.D. Anderson Cancer Center	2023-08-07	PHASE1
NCT03773302	TERMINATED	Advanced Cholangiocarcinoma; FGFR2 Gene Mutation	QED Therapeutics, a BridgeBio company	2019-12-27	PHASE3
NCT04197986	TERMINATED	Upper Tract Urothelial Carcinomas; Urothelial Bladder Cancer	QED Therapeutics, a BridgeBio company	2020-03-11	PHASE3
NCT04424966	TERMINATED	Glioma; Glioblastoma; GBM	Nader Sanai	2020-07-21	EARLY_PHASE1
NCT05019794	UNKNOWN	Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Solid Tumor	LianBio LLC	2020-05-13	PHASE2
NCT05222165	WITHDRAWN	Advanced Solid Tumor; CNS Tumor; Recurrent WHO Grade II Glioma	Helsinn Healthcare SA	2021-10-01	PHASE1; PHASE2
NCT04972253	WITHDRAWN	Bladder Transitional Cell Carcinoma; Bladder Cancer; Fibroblast Growth Factor Receptor	Guru P. Sonpavde	2021-12-23	PHASE1
NCT04504331	TERMINATED	Breast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer; PR-Positive Breast Cancer	Jennifer Lee Caswell-Jin	2020-10-13	PHASE1
NCT02150967	TERMINATED	Advanced Cholangiocarcinoma; FGFR2 Gene Mutation	QED Therapeutics, a BridgeBio company	2014-07-23	PHASE2
NCT02706691	TERMINATED	FGFR Gene Amplification; FGFR1 Gene Amplification; FGFR2 Gene Amplification; FGFR2 Gene Mutation; FGFR3 Gene Mutation; Head and Neck Squamous Cell Carcinoma; Human Papillomavirus Infection; Recurrent Head and Neck Carcinoma; Recurrent Nasopharynx Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma	University of Chicago	2018-06-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Infigratinib Phosphate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Infigratinib phosphate acts as a potent pan-inhibitor of human fibroblast growth factor receptors (FGFR1–4), binding to the receptor kinase domain to block autophosphorylation and downstream signal transduction, thereby suppressing cellular proliferation and angiogenesis. This targeted inhibition of aberrant FGFR signaling pathways directly impairs tumor expansion and dysregulated chondrocyte activity, underlying its therapeutic relevance in clinical trials for FGFR-altered conditions such as advanced cholangiocarcinoma, urothelial carcinoma, and achondroplasia.

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>).