ORILISSA

Peak

elagolix

NDAORALTABLETPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

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.

Clinical Trials (5)

NCT05648669Phase 3Unknown

A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

Started Sep 2022
336 enrolled
Endometriosis
NCT04464187N/ATerminated

A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules

Started Jan 2022
173 enrolled
EndometriosisUterine Fibrioids
NCT04614246Phase 2Terminated

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
NCT04630990N/ACompleted

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
NCT04445025Phase 1Completed

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Started Sep 2020
30 enrolled
InfertilityEndometriosis

Loss of Exclusivity

LOE Date
Aug 27, 2040
176 months away
Patent Expiry
Aug 27, 2040

Patent Records (5)

Patent #ExpiryTypeUse Code
7419983
Jul 6, 2029
SubstanceProduct
U-2360
11707464
Mar 14, 2034
U-3672
11344551
Mar 14, 2034
U-3389
10537572
Sep 1, 2036
U-2735
10682351
Sep 1, 2036
U-2850