Zoligratinib (Debio-1347) Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 997

Clinical Trials

Multiple clinical trials have evaluated zoligratinib (Debio-1347) for the treatment of advanced malignancies, primarily focusing on solid tumors and FGFR-amplified estrogen receptor-positive metastatic breast cancer. Sponsored by pharmaceutical entities such as Debiopharm International SA and academic research centers including Memorial Sloan Kettering Cancer Center, these Phase 1 and Phase 2 studies evaluated zoligratinib alone and in combination with fulvestrant. While clinical trials assessing safety, gene alterations, and FGFR fusions were terminated, a clinical trial investigating the fulvestrant combination therapy was completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03344536	COMPLETED	Breast Cancer	Memorial Sloan Kettering Cancer Center	2017-11-10	PHASE1; PHASE2
NCT03834220	TERMINATED	Solid Tumor	Debiopharm International SA	2019-03-22	PHASE2
NCT01948297	TERMINATED	Solid Tumours	Debiopharm International SA	2013-08	PHASE1
NCT03834220	Terminated	Solid Tumor	Debiopharm International SA\|Caris Life Sciences\|Optimal Research (Just In Time sites)	2019-03-22	Phase 2
NCT01948297	Terminated	Solid Tumours	Debiopharm International SA	2013-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-11-25)

Check the Zoligratinib (Debio-1347) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zoligratinib functions as a selective, orally active pan-FGFR inhibitor that targets FGFR1, FGFR2, FGFR3, and FGFR4 with IC50 values of 9.3 nM, 7.6 nM, 22 nM, and 290 nM, respectively, thereby blocking receptor autophosphorylation and downstream oncogenic signaling pathways. This molecular inhibition suppresses cancer cell proliferation and induces cell death in FGFR-altered cells, demonstrating therapeutic potential against solid tumors and FGFR-amplified breast cancers studied in clinical settings.

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>).