PharmaTher seeks FDA rare disease status for 3D printed creatine mini-tablets
PharmaTher Holdings has applied to the US FDA for Orphan Drug and Rare Pediatric Disease designations for creatine monohydrate against GAMT deficiency. The drug would be 3D printed as dissolvable mini-tablets or pellets on the company's M3DICINES platform. Decisions on both requests, plus a pre-IND meeting, are expected in the first quarter of 2027.