Leiutis Pharmaceuticals LLP recently 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 Behavioral Therapy (CBT). The product is to be prescribed only by psychiatrists.

The approval is based on a successful phase 3 clinical trial conducted in India in accordance with CDSCO requirements and will be followed by a phase 4 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.

The product combines a synthetic cannabidiol Active Pharmaceutical Ingredient (API), developed by Biophore India Pharmaceuticals, with Leiutis' proprietary nanodispersible drug delivery platform, manufactured at Zenara's CDSCO-, US Food and Drug Administrration (FDA)-, and European Union (EU)-compliant facilities. The company said the product represents end-to-end pharmaceutical innovation achieved in India, spanning API development, drug delivery, clinical development, and regulatory approval.

K. Chandrasekhar, CEO and Managing Partner, Leiutis Pharmaceuticals, 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. We thank the Government of India, clinical investigators, researchers and study participants who made it possible.”

Biophore India Pharmaceuticals developed the synthetic cannabidiol API manufacturing process and has filed a US Drug Master File (US DMF), reflecting internationally recognised quality standards.

Commenting on the development, Dr. Jagadeesh Babu Rangisetty, Chief Executive Officer (CEO), 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."

The approved product contains a fully synthetic cannabidiol (CBD) API, with no cannabis plant material used. Leiutis noted that cannabidiol is recognised as non-psychoactive and has no abuse or dependence potential, distinguishing it from other psychoactive products.

The approval comes at a time when anxiety disorders remain a significant public-health challenge in India. The National Mental Health Survey 2015-16, conducted by NIMHANS across 12 states and various publications, reported a current prevalence of 2.57 percent and a lifetime prevalence of 3.5 percent for anxiety disorders among adults. These reports and surveys also identified treatment gaps across mental disorders ranging from 28 percent to 83 percent, underscoring the need for timely diagnosis, effective treatment and continuity of mental healthcare.

The approval further strengthens Leiutis' proprietary innovation pipeline in neuropsychiatry, pain management and oncology.