Zydus Gets CDSCO Panel Nod To Study Follitropin alfa

Written by Dr. Divya Colin Published On 2022-12-08T18:00:22+05:30 | Updated On 8 Dec 2022 6:00 PM IST

Zydus Gets CDSCO Panel Nod To Study Follitropin alfa

New Delhi: The drug major Zydus has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase IV study of recombinant human follicle-stimulating hormone, Follitropin alfa.

This came after the firm presented the proposal for the conduct of Phase IV clinical trial titled "A Phase IV, single-arm, open-label, multicenter study to evaluate the safety and efficacy of recombinant human FSH (Briogyn) in female patients undergoing assisted reproductive technology" vide protocol no. FOLI.21.001, Version No.: 02; dated 20 September 2021.

Follitropin alfa injection is also used as a fertility medicine to help men with low sperm counts produce more sperm. Treatment with human chorionic gonadotropin should come before treatment with follitropin alfa.

Follitropin alpha (recombinant human follicle-stimulating hormone; follitropin alfa) is a recombinant form of follicle-stimulating hormone (FSH), an endogenous gonadotrophin.

FSH binds to the follicle-stimulating hormone receptor which is a G-coupled transmembrane receptor. The binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signalling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

At the recent SEC meeting for Reproductive and Urology held on 30th November 2022, the expert panel reviewed the proposal presented by the drug major Zydus to conduct Phase IV clinical trial for the Follitropin alfa (rFSH) Injection in multidose pre-filled glass cartridges (300 IU, 450 IU, 900 IU) or single-use Vial (75 IU).

After detailed deliberation, the committee approved the protocol for the conduct of the Phase IV trial as presented.

Also Read:MSN Laboratories gets CDSCO panel nod to manufacture, market Icatibant Injection

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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.