Derazantinib Clinical Trials

Size	Price	Qty
2mg	USD 227
5mg	USD 327

Clinical Trials

Several clinical trials evaluate derazantinib in advanced solid tumors with fibroblast growth factor receptor (FGFR) genomic alterations, including intrahepatic cholangiocarcinoma, urothelial carcinoma, gastric adenocarcinoma, and healthy volunteer pharmacokinetics. Sponsors such as Basilea Pharmaceutica and Institut für Klinische Krebsforschung IKF GmbH have conducted Phase 1, Phase 2, and Phase 1b/2 trials, with recruitment statuses ranging from completed and active to terminated or closed expanded access. Overall, these studies highlight derazantinib as a monotherapy and combination treatment for FGFR-driven malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05174650	ACTIVE_NOT_RECRUITING	Intrahepatic Cholangiocarcinoma	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	2022-04-20	PHASE2
NCT04604132	TERMINATED	Gastric Adenocarcinoma	Basilea Pharmaceutica	2020-10-06	PHASE1; PHASE2
NCT03230318	COMPLETED	Intrahepatic Cholangiocarcinoma; Combined Hepatocellular and Cholangiocarcinoma	Basilea Pharmaceutica	2017-09-28	PHASE2
NCT04045613	COMPLETED	Urothelial Carcinoma	Basilea Pharmaceutica	2019-08-02	PHASE1; PHASE2
NCT04098692	COMPLETED	Healthy Volunteers	Basilea Pharmaceutica	2019-08-08	PHASE1
NCT01752920	COMPLETED	Solid Tumor	Basilea Pharmaceutica	2012-12-10	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Derazantinib acts as a potent ATP-competitive inhibitor of fibroblast growth factor receptors (FGFR1–3) and additional receptor tyrosine kinases, effectively blocking downstream autophosphorylation and oncogenic intracellular signaling cascades. By suppressing these proliferative and survival pathways, derazantinib induces cell cycle arrest and apoptosis in FGFR-dependent tumor cells, demonstrating clinical relevance in the targeted treatment of intrahepatic cholangiocarcinoma, urothelial carcinoma, and gastric adenocarcinoma.

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>).