Zydus Life Sciences Gets CDSCO Panel Nod to Study anti-cancer drug Relugolix
New Delhi: The drug major Zydus Lifscience has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase-IV clinical trial of the anti-cancer drug Relugolix Tablets 120 mg.
This came after Zydus Lifesciences presented the proposal for a grant of permission to conduct a Phase-IV clinical trial of Relugolix 120 mg tablets along with Phase-IV clinical trial protocol (Protocol No. 24-01, Version:00, Dated:12.01.2024) before the committee.
The firm informed that CDSCO already issued permission vide No. MF-ND-54/2023 dated 16.10.2023 for the manufacture and marketing of Relugolix 120 mg tablets in the country with the condition of conducting a Phase IV clinical trial.
Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body.
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.
The mechanism of action of relugolix is as a gonadotropin-releasing hormone receptor antagonist, a cytochrome P450 3A inducer, a cytochrome P450 2B6 inducer, and a breast cancer resistance Inhibitor, P-Glycoprotein inhibitor. The physiologic effect of relugolix is by means of decreased GnRH secretion.
Earlier, the Medical Dialogues Team had reported that the Central Drug Standard Control Organization (CDSCO) had approved Zydus Lifescience to manufacture and market Relugolix Tablets 120 mg indicated for the treatment of adult patients with advanced prostate cancer, with local Phase III clinical trial waiver subject to the condition that firm should conduct Phase IV clinical trial within 3 months of approval.
In continuation, at the recent SEC meeting for oncology held on July 9, 2024, the expert panel reviewed the proposal for the grant of permission to conduct a Phase-IV clinical trial of Relugolix 120mg Tablets along with Phase-IV clinical trial protocol (Protocol No. 24-01, Version:00, Dated:12.01.2024).
After detailed deliberation, the committee recommended granting permission to conduct a Phase IV clinical trial of Relugolix 120 mg tablets as per the protocol presented by the firm.
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