CDSCO Panel Demands Structured Phase IV Protocol for Ademetionine in Liver Disease Subtypes

New Delhi: After reviewing the Phase IV clinical trial report of Ademetionine Tablets, the Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organization (CDSCO) has recommended that Akums Drugs and Pharmaceuticals should submit the structured Phase IV clinical trial protocol of Ademetionine Tablets, with three arms to include patients with fatty liver, alcoholic hepatitis and alcoholic cirrhosis.

This came after the firm presented the Phase IV clinical trial report of the drug Ademetionine Tablets before the committee.

Regarding the above, the committee observed that there is a subgroup analysis of serum ALT (Alanine Transaminase) values available for 245 patients with fatty liver and 2 patients each with alcoholic hepatitis and alcoholic cirrhosis, and did not accept the results of the study.

Ademetionine, also known as S-adenosyl-L-methionine (SAMe), primarily functions as a methyl donor in numerous biochemical reactions. It plays a crucial role in methylation processes, impacting neurotransmitter synthesis, liver function, and potentially joint health. Specifically, it contributes to the production of neurotransmitters like serotonin, dopamine, and norepinephrine, impacting mood and potentially aiding in depression treatment.

Ademetionine is used to treat various medical conditions, including depression, reduce pain and swelling in the joints, and conditions such as osteoarthritis, biliary cholangitis (an autoimmune disease of the liver), and excess cholesterol in bile and biliary and liver diseases caused by cystic fibrosis.

At the recent SEC meeting for Gastroenterology and Hepatology held on 17th March 2025, the expert panel reviewed the Phase IV clinical trial report of the drug Ademetionine Tablets before the committee.

After detailed deliberation, the committee noted that there is a subgroup analysis of serum ALT values available for 245 patients with fatty liver and 2 patients each with alcoholic hepatitis and alcoholic cirrhosis, and did not accept the results of the study.

The committee recommended that the firm submit the structured Phase IV Clinical Trial Protocol of Ademetionine Tablets, with three arms to include patients with fatty liver, Alcoholic hepatitis, and alcoholic cirrhosis.

Accordingly, the expert panel suggested that the firm should submit the Phase IV Clinical Trial Protocol to CDSCO within two months for further review by the committee.

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