ORILISSA (elagolix sodium)
Orilissa helps patients with moderate to severe pain that occurs as a result of endometriosis. It is used to manage these painful symptoms by influencing the body's hormonal signaling. Healthcare providers typically limit how long a patient stays on the medication depending on the specific dose prescribed and any other existing health conditions.
How ORILISSA Works
This medication works by binding to GnRH receptors in the pituitary gland to block natural signaling. This action suppresses the production of luteinizing hormone and follicle-stimulating hormone, which in turn lowers the levels of ovarian hormones like estradiol and progesterone in the bloodstream.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-07-23
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
ORILISSA Approval History
What ORILISSA Treats
1 indicationsORILISSA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Endometriosis
ORILISSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ORILISSA
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06253702 | 2023-0548 1R01HL150361-01, EDUC/KINESIOLOGY | Ph 4 | completed | Brain Blood Flow Responses to Stress: Sex Differences |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORILISSA FDA Label Details
Indications & Usage
FDA Label (PDF)ORILISSA is indicated for the treatment of Endometriosis.
ORILISSA Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for ORILISSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 28 active patents
Trial Analysis
- • 30 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment