Narmafotinib Clinical Trials

Size	Price	Qty
1mg	USD 219

Clinical Trials

Narmafotinib is currently being evaluated in multiple Phase 1/2 clinical trials sponsored by Amplia Therapeutics Limited for advanced pancreatic malignancies, including pancreatic ductal adenocarcinoma and metastatic disease. These ongoing studies, which are either recruiting or active but non-recruiting, assess the compound's safety, pharmacokinetics, and efficacy in combination with standard chemotherapy regimens such as gemcitabine plus nab-paclitaxel or modified FOLFIRINOX. Together, these efforts evaluate whether focal adhesion kinase inhibition can improve therapeutic outcomes in hard-to-treat pancreatic cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07026279	ACTIVE_NOT_RECRUITING	Pancreatic Cancer Metastatic	Amplia Therapeutics Limited	2025-08-18	PHASE1; PHASE2
NCT05355298	Recruiting	Pancreatic Cancer\|PDAC\|Pancreatic Ductal Adenocarcinoma	Amplia Therapeutics Limited	2022-05-31	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-05-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Narmafotinib selectively binds to and inhibits focal adhesion kinase (FAK), disrupting downstream integrin-mediated signaling pathways and focal adhesion turnover critical for tumor cell motility and survival. By suppressing these FAK-dependent signaling cascades and modifying the tumor microenvironment, the compound reduces cellular invasiveness and restores chemo-sensitivity, supporting its clinical application in combination regimens against pancreatic ductal adenocarcinoma and metastatic pancreatic cancer.

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>).