FDA Agrees with Galmed's Plan to use Aramchol Meglumine in the Randomized Double-Blind Placebo-Controlled Part of the Phase 3 ARMOR study
Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.
- Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.
- Exposure with once daily (QD) 383mg Aramchol meglumine oral dosage corresponds to that obtained with the existing twice daily (BID) 300mg Aramchol free acid form which is currently being evaluated in the Phase 3 ARMOR study.
- This allows future development of the QD regimen with a potential improvement in convenience and adherence".
- Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.