Sanofi Gets CDSCO Panel Nod to Study Venglustat

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-11-13 11:30 GMT | Update On 2024-11-13 11:30 GMT

New Delhi: Reviewing the Phase III clinical trial protocol of the GZ402671 (Venglustat) presented by the pharma major Sanofi, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to conduct the trial as presented by the firm.

This came after the firm presented Phase III clinical study protocol no. EFC17045, amended protocol 04, version number 01, dated 06 Oct 2023.

GZ402671, also known as venglustat, is a drug candidate being developed for treating several conditions, including Fabry disease, Gaucher disease type III, and GM2 gangliosidosis.

Venglustat and other GCS inhibitors reduce the accumulation of glucosylceramide by preventing its synthesis. Mutations in GBA1, which encodes the lysosomal glucocerebrosidase (GCase) enzyme, are the leading genetic risk factor for Parkinson's disease and dementia with Lewy bodies, two synucleinopathies.

At the recent SEC meeting for Neurology and Psychiatry held on 29th October 2024, the expert panel reviewed the Phase III clinical study protocol no. EFC17045, amended protocol 04, version number 01, dated 06 Oct 2023.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read: Abbott Gets CDSCO Panel Nod To Manufacture, Market Clarithromycin ER Tablets 1000 mg

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Dr. Divya Colin

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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Sanofi Gets CDSCO Panel Nod to Study Venglustat

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