Conduct Phase-III clinical trial: CDSCO Panel tells Abbott on Ademetionine for Injection 400mg

New Delhi: Responding to the proposal of import and marketing of Ademetionine for injection 400mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Abbott Limited to conduct the Phase III clinical trial of the drug Ademetionine for Injection 400mg.

This came after Abbott Limited presented the proposal for grant of permission to import and marketing of Ademetionine for injection 400mg along with Phase-III clinical trial protocol before the committee.

Ademetionine occurs naturally in cells, tissue, and body fluids. It helps to treat depression, osteoarthritis, and liver illness. In liver disease, this drug controls liver glutathione levels to prevent liver damage and the buildup of cirrhosis-related lipids outside the liver.

Ademetionine is used in the treatment of liver disease. It is used in liver conditions associated with reduced bile formation (intrahepatic cholestasis). Ademetionine protects the liver cells from toxins and helps the liver to perform its normal functions.

In depression, it affects serotonin in the brain, which communicates between brain cells and regulates mood. In osteoarthritis, it stimulates cartilage production and reduces the inflammatory mediator.

At the recent SEC meeting for Gastroenterology and Hepatology held on 13th March 2024, the expert panel reviewed the proposal for the grant of permission to import and market the Ademetionine for injection 400mg along with Phase-III clinical trial protocol before the committee.

After detailed deliberation, the committee recommended conducting a Phase-III clinical trial as per protocol (protocol No. ADEM-323-0417, version No. 1.0, dated 18.12.2023) presented by the firm.

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