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  • Abbott India Gets...

Abbott India Gets CDSCO Panel Nod To Conduct Phase III CT of Ursodeoxycholic Acid tablet

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-06T18:00:07+05:30  |  Updated On 6 Jan 2025 6:00 PM IST
CDSCO Panel Clears Abbotts Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Abbott India to conduct a phase-III clinical trial of Ursodeoxycholic Acid (UDCA) tablets 150 mg/300 mg/450 mg/600 mg.

This came after Abbott India presented the revised Phase-III clinical trial protocol along with a summary of changes before the committee.

Ursodeoxycholic acid is a bile acid used for the treatment of primary biliary cirrhosis (PBC). Ursodeoxycholic acid is a hydrophilic bile acid that mediates its biological effects via several mechanisms. Ursodeoxycholic acid (UDCA) protects hepatocytes and cholangiocytes from bile acid-induced damage, such as reactive oxygen species (ROS)-induced inflammation and mitochondrial dysfunction. UDCA was shown to reserve hepatocyte cell structures and stimulate anti-apoptotic pathways.It was also shown to prevent the production of ROS by Kupffer cells and resident macrophages in the liver, thus attenuating oxidative stress in the liver.

Last year, the expert panel at its 09th/24 meeting held on 12.09.2024 opined that the firm should revise the protocol with respect to the following points:

1. The firm shall define the normal ALT value for both males and females. The difference in ALT levels normalization has to be compared among the placebo arm and the test arm. And also, the ALT reduction value shall be defined as a percentage decrease from the baseline normal level.

2. Primary and secondary objectives shall be redefined to make the study a clinically meaningful outcome. The primary endpoint shall include fibroscan investigation at baseline and at six months of study duration, and the protocol shall also incorporate normalization of ALT value as an endpoint.

3. Sample size:

a. Shall be calculated based on single dose with respect to the placebo.

b. Shall be reworked based on the credible studies to strengthen the study objective.

In line with the above, at the recent SEC meeting for gastroenterology and Hepatology held on 12th December 2024, Abbott India presented the revised Phase-III clinical trial protocol along with a summary of changes before the committee

After detailed deliberation, the committee recommended conducting the Phase-III clinical trial as per the protocol presented by the firm.

Also Read: IQVIA Gets CDSCO Panel Nod To conduct Phase III clinical Study of Lumateperone

Ursodeoxycholic AcidcdscoAbbottabbott indiaudcaPhase III CT
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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