FDA Clears L-4-Chlorokynurenine for Phase 2 Trials in Levodopa-Induced Dyskinesia 

The Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for L-4-chlorokynurenine (AV-101, VistaGen Therapeutics, South San Francisco, CA), as a potential treatment for levodopa-induced dyskinesia. The FDA's IND clearance permits the procession of the phase 2 clinical trial of L-4-Chlorokynurenine in this indication. The US Patent and Trademark Office (USPTO) has issued a notice of allowance for US Patent Application 16/003,816 related to therapeutic use of L-4-Chlorokynurenine for treatment of dyskinesia induced by the administration of levodopa. The patent, once issued, will be in effect until at least 2034. 

"Current drug treatment options for levodopa-induced dyskinesia (LID), may cause serious side effects, including hallucinations and sedation. In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events. With its exceptional safety profile, recently successful preclinical studies in the leading primate model for LID, and the successful phase 1b NMDAR target engagement clinical study conducted by Baylor College of Medicine in healthy volunteer US military Veterans, we are excited by AV-101's potential as a novel therapy for LID," said Shawn Singh, chief executive officer of VistaGen. "These are important milestones for our AV-101 program, both a key regulatory advance and expanded commercial protection for AV-101 in the US market."