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Elagolix Sodium
CAS NO.: 832720-36-2
Chemical Formula: C32H29F5N3NaO5
Molecular Weight: 653.6000
DMF&GMP status: Please contact us for more details.
Description:
Elagolix is an orally bioavailable, second-generation, non-peptide based, small molecule compound and selective gonadotropin-releasing hormone (GnRH; LHRH) receptor antagonist, with potential hormone production inhibitory activity. Upon oral administration, elagolix competes with GnRH for receptor binding and inhibits GnRH receptor signaling in the anterior pituitary gland. This inhibits the secretion of luteinizing hormone (LH) and follicle stimulating hormone (FSH). In males, the inhibition of LH secretion prevents the release of testosterone. In women, inhibition of FSH and LH prevents the production of estrogen by the ovaries. Inhibition of GnRH signaling may treat or prevent symptoms of sex hormone-dependent disease states.

Elagolix is an oral, nonsteroidal gonadotropin releasing hormone (GnRH) antagonist that decreases estrogen production and is used to treat painful forms of endometriosis in women. Elagolix therapy is associated with a low rate of serum enzyme elevations during therapy and has yet to be linked to instances of clinically apparent liver injury.

Elagolix has been used in trials studying the basic science and treatment of Endometriosis, Folliculogenesis, Uterine Fibroids, Heavy Uterine Bleeding, and Heavy Menstrual Bleeding. As of 24 July 2018, however, the U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. It has been determined that endometriosis is one of the most common gynecologic disorders in the United States. In particular, estimates suggest that one in ten women of reproductive age is affected by endometriosis and experience debilitating pain symptoms. Moreover, women who are affected by this condition can suffer for up to six to ten years and visit multiple physicians before receiving a proper diagnosis. Subsequently, as Orilissa (elagolix) was approved by the FDA under priority review, this expedited new approval gives healthcare professionals another valuable option for treating the potentially unmet needs of women who are affected by endometriosis, depending on their specific type and severity of endometriosis pain.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
ELAGOLIX SODIUMTABLET;ORALEQ 150MG BASEORILISSAABBVIE INC
ELAGOLIX SODIUMTABLET;ORALEQ 200MG BASEORILISSAABBVIE INC
ELAGOLIX SODIUM;ESTRADIOL;NORETHINDRONE ACETATE;ELAGOLIX SODIUMCAPSULE;ORALEQ 300MG BASE 1MG 0.5MG; EQ 300MG BASEORIAHNN (COPACKAGED)ABBVIE INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
N.A.N.A.N.A.N.A.N.A.
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 07/23/2023