Abstract

A REVIEW ON ELAGOLIX SODIUM: AN ORAL GONADOTROPIN - RELEASING HORMONE (GnRH) RECEPTOR ANTAGONIST FOR ENDOMETRIOSIS ASSOCIATED PAIN

Gaurav S. Mahalpure*, Dr. Rajendra D. Wagh and Bhushan J. Mali

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Abstract

Elagolix sodium is an orally bioavailable, second-generation, nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist. Is being developed AbbVie and Neurocrine Biosciences for the treatment of reproductive hormone-dependent disorders in women. Elagolix sodium is a drug used for the treatment of moderate to severe pain associated with endometriosis and the most common gynecological benign disease, uterine fibroids. Phase-I and phase-II clinical trials have demonstrated the safety of Elagolix sodium and its efficacy in partial and reversible suppression of ovarian estrogen production resulting in improvements in endometriosis-related pain. Phase-III clinical development for heavy menstrual bleeding associated with uterine fibroids in the previously mentioned locations. This drug is available and approved 150 mg once daily and 200 mg twice daily dosing regimens for the drug administration of moderate to severe pain associated with endometriosis. This review article summarizes the clinical pharmacology studies (i.e., mechanism of action, pharmacokinetics, and pharmacodynamics studies), pharmacogenomic activities, therapeutic trials, contraindications, adverse effects, ongoing clinical trials, safety and tolerability, and clinical trials of Elagolix sodium as an oral gonadotropin-releasing hormone (GnRH) receptor antagonist.

Keywords: Elagolix sodium, GnRH Antagonist, Orilissa, Endometriosis, Uterine Fibroids.