Intas Pharmaceuticals has secured approval from the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial for its Recombinant Human Follicle Stimulating Hormone (R-hFSH) solution for injection (900 IU/1.44 mL). This decision follows a thorough review of Intas' clinical study protocol.
The Phase III trial, identified as Protocol no. 0232-4 Version 1.0 dated 17.07.2024, is designed as a randomized, assessor-blind, active-controlled, parallel-group, two-arm study. The primary objective is to compare the safety, efficacy, and immunogenicity of Intas Pharmaceuticals' R-hFSH injection with Follitropin Alfa (Gonal-F) of Merck Serono Ltd. in adult females undergoing Assisted Reproductive Technology (ART).
Follitropin alfa, the active ingredient, is a recombinant DNA-derived human FSH preparation. It is indicated to stimulate ovarian follicular growth in women without primary ovarian failure and to stimulate spermatogenesis in men with hypogonadotropic hypogonadism. FSH is essential for normal follicular growth, maturation, gonadal steroid production, and spermatogenesis.
During the SEC meeting for Reproductive Health held on October 23, 2024, the expert panel carefully evaluated Intas Pharmaceuticals' proposal for the Phase III clinical trial of R-hFSH (Follitropin alfa).
Following detailed deliberation, the committee granted permission to proceed with the Phase III clinical trial as per the presented protocol. However, the committee stipulated that the study should include a broader range of tertiary care centers and government sites to enhance the diversity and representativeness of the study population.
