Narmafotinib Large-Scale Manufacture Complete by Amplia Therapeutics

Amplia Therapeutics announced on January 22, 2026, the successful completion of its first large-scale manufacture of narmafotinib, producing approximately 13 kg of active pharmaceutical ingredient (API) to required purity and quality specifications.12

This marks a key transition from R&D to commercial manufacturing, achieving production efficiencies and cost savings, essential for Phase 3 readiness.12

The API, manufactured under GMP standards, will be converted into oral capsules to support ongoing pancreatic cancer trials (ACCENT and AMPLICITY) and other planned studies.13

Narmafotinib is a potent FAK inhibitor showing promising results in pancreatic cancer trials, including a 35% response rate in the ACCENT trial.1

Sources:

1. https://www.biospace.com/press-releases/narmafotinib-large-scale-manufactre-complete

2. https://www.marketscreener.com/news/amplia-therapeutics-limited-announces-successful-completion-of-the-first-large-scale-manufactre-of-n-ce7e58d3db8efe22

3. https://delta.larvol.com/Products/?ProductId=29fd67c6-c29d-4034-b4e9-11eca98950ac