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  • CDSCO Panel Recommends...

CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma

Parthika PatelWritten by Parthika Patel Published On 2025-07-09T23:37:18+05:30  |  Updated On 9 July 2025 11:37 PM IST
CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma
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New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has recommended to conduct Phase IV clinical trial for a fixed-dose combination (FDC) topical gel developed by Precise Biopharma Pvt. Ltd.

The formulation combines Clindamycin Phosphate IP 1.2% w/w (equivalent to Clindamycin 1% w/w) and Hydrous Benzoyl Peroxide IP (equivalent to anhydrous Benzoyl Peroxide 3.75%), a combination widely used in dermatological therapy for acne.

As per the condition outlined in Form CT-23 dated 11.01.2024, the company was required to submit its Phase IV clinical trial protocol for regulatory review. The firm presented the protocol during the 6th meeting of the SEC (Dermatology & Allergy) held on June 11, 2025, at CDSCO Headquarters in New Delhi.

Following a detailed evaluation, the expert panel recommended to conduct Phase IV study. The committee emphasized that the trial results must be submitted to CDSCO for further review upon completion.

The FDC gel combines two active ingredients frequently prescribed for acne treatment:

Clindamycin, a lincosamide antibiotic that inhibits bacterial protein synthesis, and

Benzoyl Peroxide, a keratolytic and bactericidal agent known to reduce acne-causing bacteria and inflammation.

Also Read: Akums Gets CDSCO Panel Nod for BE Study of Rizatriptan-Meloxicam FDC, Told to Revise Phase III Protocol
CDSCOFDC gelacne treatmentclindamycin phosphatebenzoyl peroxidephase IV clinical trialPrecise Biopharmaclinical trial protocolForm CT-23topical acne gel
Parthika Patel
Parthika Patel

    M. Pharm (Pharmaceutics)

    Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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