India Approves a Synthetic CBD Drug for Anxiety

The Indian drug regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has approved an oral solution containing 150 mg/mL of CBD (15%) Intended for the treatment of mild to moderate anxiety disorders. Treatment must be prescribed by a psychiatrist and used in conjunction with cognitive-behavioral therapy.

The product was developed by Leiutis Pharmaceuticals, in collaboration with Indian partners, and is based on Synthetic CBD rather than from an extract derived from the plant. The resulting molecule is chemically identical to plant-based cannabidiol, but its manufacturing process supposedly allows for more precise control over its purity and composition.

A high-potency formulation

With a concentration of 150 mg/mL, the drug falls within the range of concentrations typically found in oils CBD intended for the wellness market. Its formulation uses a technology known as nanodispersible technology, designed to promote the body’s absorption of cannabidiol.

The product was developed in India: the synthetic CBD comes from Biophore India Pharmaceuticals, while Leiutis developed the delivery system. The finished drug is manufactured by Zenara Pharma, with all three companies based in Hyderabad.

This approach is intended to facilitate future international expansion. According to the companies involved, the technical documentation regarding synthetic CBD has been submitted to the Food and Drug Administration (FDA) in the United States, with a view to potential regulatory actions in the United States.

Positive results in a clinical trial

The Indian approval comes after a Phase III clinical trial conducted at several centers across the country. Published in 2024 in the’Asian Journal of Psychiatry, the study involved 178 participants, divided equally between the group receiving CBD and the group receiving a placebo. The study lasted approximately 15 weeks.

The researchers evaluated including symptoms of anxiety using the GAD-7 and HAM-A scales. Both primary outcomes showed a statistically significant improvement in favor of CBD compared with placebo. Favorable differences were also observed with regard to depressive symptoms, overall disease severity, and sleep quality.

In terms of safety, 41 participants reported at least one adverse event, but no serious adverse events were reported during the study. The authors also note that the formulation was generally well tolerated.

A significant market, but one that has yet to be tapped

The commercial stakes are particularly high in India, where anxiety disorders account for a significant portion of the burden of mental illness. The study published in the’Asian Journal of Psychiatry highlights, in particular, the high prevalence of these disorders in the country.

However, the introduction of this medication does not mean that CBD will replace existing treatments. Antidepressants, anxiolytics, and psychotherapy already play an important role in the Anxiety Management. The cost of the new treatment, its acceptance by psychiatrists, whether it will be covered by insurance, and its results compared to standard treatments will be key factors in its development.

A Phase IV study This should now make it possible to evaluate the drug under conditions that more closely resemble real-world practice. Zenara Pharma plans, in particular, to conduct a comparison with the standard treatment. The results of this data will therefore be crucial in determining the role this new CBD-based drug could actually play in Indian psychiatry.