Leiutis Pharmaceuticals LLP, a speciality therapeutics company, has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to collaboration partner Zenara Pharma to manufacture its proprietary Synthetic Cannabidiol Oral Solution 150 mg/mL for the management of mild to moderate anxiety disorders when used in conjunction with cognitive behavioural therapy (CBT). The product is to be prescribed only by psychiatrists.

The approval is based on a successful Phase III clinical trial conducted in India in accordance with CDSCO requirements and will be followed by a Phase IV study. Leiutis said it marks the world's first regulatory approval of a fully synthetic cannabidiol oral solution for the management of mild to moderate anxiety disorders. The product was researched, developed, patented and clinically validated entirely in India.