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Rachel V Thomas

India Approves World's First Synthetic CBD Therapy for Anxiety Disorders

In a global first, <span>India</span>'s drug regulator has approved a fully <span>synthetic cannabidiol</span> (CBD) therapy for the treatment of mild to moderate <span>anxiety disorders</span>, marking a significant milestone in cannabinoid-based medicine.

The Central Drugs Standard Control Organisation (<span>CDSCO</span>) has granted regulatory approval to <span>Zenara Pharma</span>, the manufacturing partner of <span>Leiutis Pharmaceuticals</span>, to produce a synthetic cannabidiol oral solution (150 mg/ml). The prescription-only therapy is intended to be used alongside cognitive behavioural therapy (CBT) for managing mild to moderate anxiety disorders.

In a statement, Leiutis Pharmaceuticals said the approval follows a successful Phase III clinical trial conducted in India under CDSCO guidelines. A Phase IV post-marketing study will now be carried out to further evaluate the therapy.

<h2>World's First Fully Synthetic <span rel="noindex">CBD Therapy</span></h2>

Leiutis noted that "this is the first regulatory approval anywhere in the world for a fully synthetic cannabidiol oral solution for anxiety disorders".

K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, said the approval is the result of nearly a decade of cannabinoid research, including the development of a proprietary synthetic cannabinoid manufacturing process, novel drug-delivery technology, and extensive preclinical and clinical studies.

“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,” Chandrasekhar said.

The newly approved medicine contains a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API), meaning no cannabis plant material is used in its production.

<ul><li>A synthetic cannabidiol API developed by Biophore India Pharmaceuticals.</li><li>Leiutis Pharmaceuticals' proprietary nanodispersible drug-delivery platform to improve absorption.</li><li>Manufacturing by Zenara Pharma at facilities compliant with CDSCO, US FDA and European regulatory standards.</li></ul>

Biophore has also filed a United States Drug Master File (US DMF) for the synthetic CBD manufacturing process, reflecting internationally recognized quality standards.

The approval comes at a time when anxiety disorders are rising sharply in India. According to a recent analysis from the Global Burden of Disease Study published in <em>The Lancet</em>, anxiety disorders in India increased by 123.5% between 1990 and 2023.

The prevalence rose from 2,591.9 cases per lakh population in 1990 to 5,792.8 cases per lakh in 2023, driven largely by increasing rates of anxiety and depression.

Cannabidiol (CBD) is one of the naturally occurring compounds found in hemp and cannabis plants. Unlike THC, it does not produce intoxicating effects.

CBD has been studied for several potential therapeutic uses, including:

<ul><li>Reducing anxiety symptoms</li><li>Relieving chronic pain</li><li>Improving sleep</li><li>Managing certain seizure disorders</li><li>Reducing inflammation</li></ul>

The newly approved product, however, uses synthetic CBD, which is produced entirely in a laboratory rather than extracted from the cannabis plant. Synthetic CBD offers a highly consistent and contaminant-free formulation, helping standardize dosing and quality.

<h2>Does CBD Have Proven Medical Benefits?</h2>

CBD already has established medical use in certain seizure disorders in some countries and continues to be investigated for a range of other conditions, including anxiety, chronic pain, inflammation and schizophrenia. 

CBD is generally well-tolerated, but some users may experience mild side effects like drowsiness, reduced appetite, or diarrhea. Side effects are often due to interactions with other medications.

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In a global first, India's drug regulator has approved a fully synthetic cannabidiol (CBD) therapy for the treatment of mild to moderate anxiety disorders, marking a significant milestone in cannabinoid-based medicine.The Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to Zenara Pharma, the manufacturing partner of Leiutis Pharmaceuticals, to produce a synthetic cannabidiol oral solution (150 mg/ml). The prescription-only therapy is intended to be used alongside cognitive behavioural therapy (CBT) for managing mild to moderate anxiety disorders.In a statement, Leiutis Pharmaceuticals said the approval follows a successful Phase III clinical trial conducted in India under CDSCO guidelines. A Phase IV post-marketing study will now be carried out to further evaluate the therapy.World's First Fully Synthetic CBD TherapyLeiutis noted that "this is the first regulatory approval anywhere in the world for a fully synthetic cannabidiol oral solution for anxiety disorders".K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, said the approval is the result of nearly a decade of cannabinoid research, including the development of a proprietary synthetic cannabinoid manufacturing process, novel drug-delivery technology, and extensive preclinical and clinical studies.“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,” Chandrasekhar said.What Is the New CBD Therapy?The newly approved medicine contains a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API), meaning no cannabis plant material is used in its production. The therapy combines:A synthetic cannabidiol API developed by Biophore India Pharmaceuticals.Leiutis Pharmaceuticals' proprietary nanodispersible drug-delivery platform to improve absorption.Manufacturing by Zenara Pharma at facilities compliant with CDSCO, US FDA and European regulatory standards.Biophore has also filed a United States Drug Master File (US DMF) for the synthetic CBD manufacturing process, reflecting internationally recognized quality standards.Why This Approval MattersThe approval comes at a time when anxiety disorders are rising sharply in India. According to a recent analysis from the Global Burden of Disease Study published in The Lancet, anxiety disorders in India increased by 123.5% between 1990 and 2023.The prevalence rose from 2,591.9 cases per lakh population in 1990 to 5,792.8 cases per lakh in 2023, driven largely by increasing rates of anxiety and depression.What Is CBD?Cannabidiol (CBD) is one of the naturally occurring compounds found in hemp and cannabis plants. Unlike THC, it does not produce intoxicating effects.CBD has been studied for several potential therapeutic uses, including:Reducing anxiety symptomsRelieving chronic painImproving sleepManaging certain seizure disordersReducing inflammationThe newly approved product, however, uses synthetic CBD, which is produced entirely in a laboratory rather than extracted from the cannabis plant. Synthetic CBD offers a highly consistent and contaminant-free formulation, helping standardize dosing and quality.Does CBD Have Proven Medical Benefits?CBD already has established medical use in certain seizure disorders in some countries and continues to be investigated for a range of other conditions, including anxiety, chronic pain, inflammation and schizophrenia. CBD is generally well-tolerated, but some users may experience mild side effects like drowsiness, reduced appetite, or diarrhea. Side effects are often due to interactions with other medications.

india approves world's first synthetic cbd therapy for anxiety disorders

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