Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to its collaboration partner Zenara Pharma to manufacture a Synthetic Cannabidiol Oral Solution 150 mg/mL for the management of mild to moderate anxiety disorders, to be used alongside cognitive behavioural therapy (CBT).

The prescription-only therapy, which is to be prescribed exclusively by psychiatrists, is based on a successful Phase III clinical trial conducted in India in accordance with CDSCO requirements. The companies plan to undertake a Phase IV study following the approval.

According to Leiutis, the approval marks the world's first regulatory approval of a fully synthetic cannabidiol oral solution for treating mild to moderate anxiety disorders. The product has been researched, developed, patented and clinically validated entirely in India.

The therapy combines a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API) developed by Biophore India Pharmaceuticals with Leiutis' proprietary nanodispersible drug delivery platform, and will be manufactured at Zenara Pharma's CDSCO-, US FDA- and EU-compliant manufacturing facilities.

The company said the product represents end-to-end pharmaceutical innovation developed in India, encompassing API development, drug delivery technology, clinical research and regulatory approval.

Commenting on the milestone, K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, said, “This approval reflects nearly a decade of dedicated cannabinoid research, encompassing the development of a proprietary synthetic cannabinoid API manufacturing process, innovative drug-delivery technology, and a robust body of preclinical and clinical evidence. Developed entirely in India and protected by patents in key markets, this approval is a significant milestone for our innovation pipeline, paving the way for next-generation cannabinoids.” 

Dr. Jagadeesh Babu Rangisetty, Chief Executive Officer of Biophore India Pharmaceuticals, said, "We are proud that this global first was developed in India. The journey from concept to approval demanded scientific perseverance, continuous learning and close collaboration at every stage. This approval reinforces India's capability to deliver globally relevant pharmaceutical innovation from discovery through commercialisation," he said.