Sanofi Healthcare India Gets CDSCO Panel Nod To study SAR441566

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-05 12:15 GMT   |   Update On 2025-05-05 12:15 GMT
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New Delhi: SanofiHealthcare India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the drug SAR441566.

This came after the firm presented phase II clinical study protocol no. DRI17822 Amendment number 01 Version 01 Dated 19 Dec 2024.

SAR-441566 is under development for the treatment of inflammatory bowel disease, rheumatoid arthritis and plaque psoriasis. It is administered through the oral route. The drug candidate acts by targeting TNF.

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SAR441566 is a small molecule inhibitor of tumor necrosis factor (TNF) signaling, currently under development for treating inflammatory conditions like Crohn's disease, rheumatoid arthritis, and plaque psoriasis.

At the recent SEC meeting for gastroenterology and hepatology held on 18th March 2025, the expert panel reviewed phase II clinical study protocol no. DRI17822 Amendment number 01 Version 01 Dated 19 Dec 2024.

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

Also Read:CDSCO panel grants clearance to Morepen Labs to conduct BE studies for fatty liver disease drug Resmetirom

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