Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to collaboration partner Zenara Pharma to manufacture and market 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.
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-, FDA-, and 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.
“We have been researching cannabinoids for nearly a decade, recognising their unique pharmacological potential. Over the years, we have invested in developing synthetic manufacturing processes for the API, our proprietary drug delivery technology, and establishing clinical efficacy through rigorous clinical research. This product has been developed entirely in India and is protected by patents in India and key global markets. We are delighted to see years of dedicated research and innovation culminate in this important milestone. The approval marks a major milestone for our innovation pipeline and reinforces our commitment to developing globally competitive medicines originating from India. We appreciate the Government of India’s continued emphasis on fostering pharmaceutical innovation and are deeply grateful to the clinical investigators, researchers and study participants whose contributions made this achievement possible,” said K. Chandrasekhar, CEO & Managing Partner, Leiutis Pharmaceuticals LLP.
Biophore India Pharmaceuticals developed the synthetic cannabidiol API manufacturing process and has filed a United States Drug Master File (US DMF), reflecting internationally recognised quality standards.
Commenting on the development, Dr. Jagadeesh Babu Rangisetty, Chief Executive Officer, Biophore India Pharmaceuticals, said, “We are immensely 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. Bringing this breakthrough to mental healthcare reflects our commitment to developing high-quality, science-driven medicines that benefit patients and healthcare professionals in India and around the world.”
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 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% and a lifetime prevalence of 3.5% for anxiety disorders among adults. These surveys and reports also identified treatment gaps across mental disorders ranging from 28% to 83%, underscoring the need for timely diagnosis, effective treatment and continuity of mental healthcare.
Dr. Sanjay Sharma, President – Corporate Strategy & Growth, Leiutis Pharmaceuticals, said: “We are delighted with CDSCO approval and look forward to making this therapy available to patients across India through psychiatrists and our collaborative network”.
The approval further strengthens Leiutis’ proprietary innovation pipeline in neuropsychiatry, pain management and oncology.
(Disclaimer) This press release is intended for psychiatrists and medical professionals only. It is not intended for patients or the general public and should not be treated as promotional material for consumers.