LYNKUET (elinzanetant)
Lynkuet helps patients with moderate to severe vasomotor symptoms that occur during menopause. It is used for individuals experiencing these symptoms to help manage the physical discomfort associated with menopausal changes. This medication provides a targeted approach for those seeking relief from these specific thermoregulatory issues.
How LYNKUET Works
This drug works by blocking the signaling of neurokinin 1 and neurokinin 3 receptors. By inhibiting Substance P and Neurokinin B on specific neurons, it helps regulate the neuronal activity responsible for body temperature control. This process helps stabilize the thermoregulatory system to reduce the occurrence of hot flashes.
Details
- Status
- Prescription
- First Approved
- 2025-10-24
- Patent Cliff
- 2045
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LYNKUET Approval History
What LYNKUET Treats
2 indicationsLYNKUET is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Menopause
LYNKUET 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 LYNKUET
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06112756 NIRVANA results posted | 22423 2023-504955-28-00 | Ph 2 | completed | A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause |
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.
LYNKUET FDA Label Details
Indications & Usage
FDA Label (PDF)LYNKUET is indicated for the treatment of Vasomotor Symptoms; Menopause.
LYNKUET Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LYNKUET
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2045
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.