The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended that drug major Sun Pharma conduct a Phase III clinical trial of Elagolix 150 mg tablets for Test Arm 1 by monitoring bone marrow density for six months and with the follow-up of serum estrogen levels of the subjects.

This came after the firm presented the proposal to manufacture and market the drug Elagolix in 150 mg and 200 mg tablets by conducting a Phase-III clinical trial in the country.

Elagolix is a gonadotropin-releasing hormone receptor antagonist used to treat moderate to severe pain in endometriosis.

Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus.

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The growths themselves are referred to as lesions, and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowels or bladder.

The growth of these lesions is dependent upon the estrogen hormone.

Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland.

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At the recent SEC meeting for Reproductive and Urology held in July 27, 2022, the expert panel reviewed the proposal presented by the firm to manufacture and market the drug Elagolix 150mg and 200mg tablets.

After detailed deliberation, the committee recommended conducting Phase III clinical trial for test arm 1(Elagolix 150mg tablets) by monitoring Bone marrow density for 6 months and with the follow-up of serum estrogen level of the subjects.

Furthermore, regarding the Phase III study of Elagolix 200mg Tablets with test arm 2, the committee raised safety concerns with subjects at higher doses and did not consider the request to conduct a Phase III study with test arm 2 (Elagolix 200mg Tablets).

Accordingly, the committee asked the firm to submit the revised protocol for further evaluation.

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