Last reviewed 2026-04-20 · How we verify

Orilissa (ELAGOLIX)

Orilissa blocks the hormone signals that stimulate the growth of endometrial tissue.

Orilissa (Elagolix) is a small molecule gonadotropin-releasing hormone receptor antagonist developed by Abbvie, targeting the gonadotropin-releasing hormone receptor to treat endometriosis. It was FDA approved in 2018 and remains a patented product with no generic manufacturers. Orilissa works by blocking the hormone signals that stimulate the growth of endometrial tissue, providing relief from symptoms associated with endometriosis. Key safety considerations include potential impacts on reproductive hormones and bone density. As a patented product, Orilissa is not yet available as a generic.

At a glance

Mechanism of action

ORILISSA is GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA 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.

Approved indications

• Endometriosis

Boxed warnings

• WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )] . ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke and women with uncontrolled hypertension [see Contraindications ( 4 )] . WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See full prescribing information for complete boxed warning. Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. ( 5.1 ) ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension. ( 4 )

Common side effects

• Hot Flush
• Headache
• Nausea
• Insomnia
• Mood altered, mood swings
• Amenorrhea
• Depressed mood, depression, depressive symptoms and/or tearfulness
• Anxiety
• Arthralgia
• Appendicitis
• Abdominal pain
• Back pain

Key clinical trials

• Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain (PHASE3)
• A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain (PHASE3)
• A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
• A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
• Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp (PHASE3)
• Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (PHASE3)
• Brain Blood Flow Responses to Stress: Sex Differences (PHASE4)
• Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Orilissa CI brief — competitive landscape report
• Orilissa updates RSS · CI watch RSS
• AbbVie portfolio CI