NDAORALTABLETPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ORILISSA (elagolix) by AbbVie is gland. Approved for endometriosis, uterine fibroids. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORILISSA (elagolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved in 2018 for endometriosis and uterine fibroids. It works by suppressing luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby reducing estradiol and progesterone to alleviate gynecological symptoms. The drug represents a significant shift from injectable GnRH agonists toward convenient oral administration.
$4MPart D
Peak14.3 years to LOEProduct is in peak commercial phase with modest Medicare claims volume; AbbVie likely maintains a focused, efficient brand team rather than an expanding franchise.
Mechanism of Action
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.
Indications (2)
Clinical Trials (20)
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
Started Sep 2022
336 enrolled
Endometriosis
A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
Started Jan 2022
173 enrolled
EndometriosisUterine Fibrioids
Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb
Started Jan 2021
215 enrolled
Endometriosis
Study Of Oral Elagolix Tablets To Assess the Tolerability and Change in Disease Symptoms in Adult Female Participants With Moderate to Severe Endometriosis-associated Pain
Started Dec 2020
117 enrolled
Endometriosis
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis
Started Sep 2020
30 enrolled
InfertilityEndometriosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.