New Delhi: Pharmaceutical major Sun Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to study Elagolix (150 and 200 mg), which is a gonadotropin-releasing hormone receptor antagonist used to treat moderate to severe pain in endometriosis.

However, this approval is subjected to a condition that the firm should include both a T-score and a Z-score for monitoring bone marrow density (BMD).

This came after the firm presented the revised Phase III clinical trial protocol of Elagolix (150 and 200 mg) before the committee, in light of an earlier SEC recommendation dated July 28, 2012.

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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.

Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse.

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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 on 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.

Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol, and progesterone.

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