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  • IQVIA gets CDSCO panel...

IQVIA gets CDSCO panel Nod To Study ABX464

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-05-08T17:30:36+05:30  |  Updated On 8 May 2023 5:30 PM IST
Indian Pharma Market Expands 8.4% in January, Dapagliflozin, Vonoprazan Among Top-Selling Drugs: IQVIA
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New Delhi: The leading global contract research organization, IQVIA has got the green signal from the Subject Expert Committee(SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase-III clinical trial of ABX464 belonging to the class of organic compounds known as aminoquinolines and derivatives.

This came after the firm presented Phase-III clinical trial protocol number- ABX464-106, Version -3.0, dated Oct. 06, 2022, before the committee.
ABX464 is a first-in-class, clinical-stage, small molecule for oral administration that has shown strong anti-inflammatory effects in the DSS-model for inflammatory bowel disease (IBD) and also prevents replication of the HIV virus.
ABX464 interacts with the cap-binding complex, allowing specific splicing of anti-inflammatory miR-124 (microRNA-124), leading to a cascade of dextran sulfate sodium modulating proinflammatory cytokines.
At the recent SEC meeting Gastroenterology & Hepatology held on 18th April 2023, the expert panel reviewed the Phase III clinical protocol number- ABX464-106, Version -3.0, dated Oct. 06, 2022,
After detailed deliberation, the committee recommended the grant of permission to conduct the study.

Also Read:Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine

ABX464cdscoIQVIAphase 3 trial
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.

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