India’s approval of a synthetic CBD medication for the treatment of mild to moderate anxiety disorders gives pharmaceutical-grade CBD a new application in one world’s biggest potential markets. Mental health market.
CDSCO (India’s national drug regulator) has approved Leiutis Pharmaceuticals’ 150 mg/mL CBD orally solution in combination with cognitive behavioral treatment. This drug can only be prescribed by psychiatrists.
With 150 milligrams/mL, this new product has a concentration that is far higher than typical CBD oils for wellness, which typically contain between 10-50 milligrams/mL. Leiutis formulation contains more CBD than Epidiolex (the FDA approved CBD epilepsy medication), which has 100 mg/mL. Epidiolex contains CBD from hemp flower, which is highly purified. This drug, used to treat children with severe epilepsy, has a high concentration of CBD.
All Indian
This approval is the result of nearly a decade’s dedicated research into cannabinoid compounds, including the creation of an innovative synthetic cannabinoid-API manufacturing process and innovative drug delivery technology. It also reflects a substantial body of clinical and preclinical evidence, according to K. Chandrasekhar.
The drug is manufactured without cannabis and has been approved by the FDA.
It is the same molecule of cannabidiol when it’s synthesized chemically. It is not more potent, but it offers greater consistency and purity while eliminating other cannabis plant compounds.
Leiutis formulation contains CBD created by Biophore Indian Pharmaceuticals, and Leiutis proprietary delivery system to enhance CBD absorption. Zenara Pharma produces the final drug. The three companies all have their headquarters in Hyderabad.
According to companies, technical documents on synthetic CBD have been sent to the U.S. Food and Drug Administration. These could be used in the future for U.S. pharmaceutical applications.
The Clinical Evidence
The CDSCO decision was made after a Phase 3 trial. This is the final stage of testing to determine if a drug will be effective and safe enough for its intended population. In 2024, the results of this trial were published in Asian Journal of Psychiatry.
Leiutis is approved for the treatment of anxiety disorders ranging from mild to moderate, when used in combination with cognitive-behavioral therapy. This approval may affect a large number of patients. The most recent National Mental Health Survey in India (2015-2016), estimated that 2,57% of adult Indians had an anxiety disorder. Around 60% of the patients experienced some form of disability. Over 80% of patients were not being treated.
It would compete in a field that is dominated with established therapies, such as antidepressants or anti-anxiety medicines, psychotherapy, etc. Pricing, physician acceptance, reimbursements and the effectiveness and safety of this product are all factors that will determine its commercial prospects.
Leiutis and its partners must next carry out a Phase IV study — post-approval testing used to evaluate a medicine under broader, real-world conditions and gather additional information about safety and effectiveness. Zenara said that the Phase IV study will compare CBD treatments with existing standards of care.
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