Hetero Healthcare Gets CDSCO Panel Nod To Conduct Phase III clinical trial of Tioconazole vaginal film 300 mg
New Delhi:Hetero Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial study of antifungal drug Tioconazole vaginal film 300 mg.
This came after the firm presented justification for the development of the proposed dose of 300 mg along with release pattern data of the proposed formulation, toxicity data, anticipated side effects, and supportive clinical evidence before the committee.
Earlier, the Medical Dialogues Team reported the committee had opined the firm submit adequate rationale/justification for the development of a proposed dose of 300 mg in such high strength along with release pattern data of the proposed formulation, adequate toxicity data, anticipated side effects, and supportive clinical evidence of the proposed dosage form to CDSCO.
The applied dose is 5-fold higher than the approved dose (Ticonazole vaginal gel 65 mg/g).
Tioconazole is an antifungal medication used to treat yeast and fungal infections, including vaginal yeast infections, jock itch, athlete's foot, and ringworm.
Tioconazole is an imidazole antifungal used to treat fungal and yeast infections. Topical formulations are used for ringworm, jock itch, athlete's foot, and tinea versicolor, or "sun fungus."
Tioconazole interacts with 14-alpha demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability.
At the recent SEC meeting for antimicrobials and antivirals held on 13th and 14th February 2025, the expert panel reviewed the justification for the development of the proposed dose of 300 mg along with release pattern data of the proposed formulation, toxicity data, anticipated side effects, and supportive clinical evidence.
After detailed deliberation, the committee recommended the grant of permission to conduct Phase III clinical trial study as per the protocol presented on August 22, 2024, and further mentioned submitting the results for further deliberation
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