Conduct Phase III CT: CDSCO Panel Tells Sun Pharma on FDC Relugolix plus Estradiol plus Norethindrone Acetate Tablets

This came after the drug major Sun Pharma presented its proposal for a Phase-III clinical trial waiver for the grant of permission to manufacture and market FDC of Relugolix, Estradiol, and Norethindrone Acetate Tablets (40 mg + 1 mg + 0.5 mg) along with the bioequivalance (BE) study report.

The combination of Relugolix, estradiol, and norethindrone is used to manage heavy menstrual bleeding caused by uterine leiomyomas (fibroids) in premenopausal women.

Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions.

Relugolix is used in men to treat advanced prostate cancer. Relugolix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It helps treat prostate cancer by lowering the amount of testosterone hormone in the blood. In some patients, testosterone will cause prostate cancer to grow larger.

Estradiol is an estrogenic steroid used to treat vasomotor symptoms of vulvar and vaginal atrophy in menopause, hypoestrogenism, prevention of postmenopausal osteoporosis, treatment of breast cancer, and advanced androgen-dependent carcinoma of the prostate.

Norethisterone, also known as norethindrone, is a synthetic progestational hormone belonging to the 19-nortestosterone-derived class of progestins. It is further classified as a second-generation progestin, along with levonorgestrel and its derivatives, and is the active form of several other progestins including norethynodrel and lynestrenol. Norethisterone mimics the actions of endogenous progesterone, albeit with a greater potency, and is used on its own or in combination with estrogen derivatives in a variety of applications including contraception and hormone replacement therapy

At the recent SEC meeting for Reproduction and Urology held on 19th December 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma for the grant of permission to manufacture and market FDC of Relugolix, Estradiol and Norethindrone Acetate Tablets (40 mg + 1 mg + 0.5 mg) along with BE study report.

After detailed deliberation, the committee noted that there is no safety and efficacy data on the Indian population.

Hence, the committee recommended that the firm should conduct a Phase-III clinical trial for the proposed indication and accordingly, the firm should submit the clinical trial protocol to CDSCO for further consideration.

Also Read: AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab