Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA
ACS Omega December 20, 2021 Jay B. Nair, Linda B Hakes, Berra Yazar‐klosinski et al. 12 citations
A fully validated cGMP synthesis of up to 5 kg (≈30,000 patient doses) of MDMA has been achieved for the first time, using a four-step process starting from a noncontrolled material. The overall yield was 41–53% over four steps, and chemical purity exceeded 99.9% by HPLC in all validation trials. This cGMP-compliant MDMA will support ongoing clinical trials and potential future therapeutic use if FDA approval is obtained.