Posted by Michael Wonder on 03 Oct 2025
Nacuity Pharmaceuticals granted US FDA breakthrough therapy designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
2 October 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary, investigational therapy for the treatment of patients with retinitis pigmentosa.
In addition to the benefits of fast track designation previously granted to NPI-001, a drug that receives breakthrough therapy designation is eligible for intensive guidance on efficient drug development and organizational commitment from FDA.
