NDAORALCAPSULE
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
4/8 — Partial
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYNKUET (elinzanetant) is an oral small-molecule capsule approved by the FDA on October 24, 2025, representing a novel therapeutic approach in Bayer's portfolio. The specific indication and mechanism of action are not yet disclosed in available data, but the drug enters the market as a new chemical entity with potential for multiple therapeutic applications.
Launch18.9 years to LOE
As a newly launched product with no reported competitive pressure, early-stage commercial teams will focus on market establishment, payer access, and prescriber education to capture market share.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
Started Jun 2026
1,500 enrolled
Vasomotor Symptoms (VMS) Associated With Menopause
A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants
Started Nov 2025
18 enrolled
Vasomotor Symptoms
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
Started Jan 2024
64 enrolled
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenHot Flashes
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Started Nov 2023
110 enrolled
Sleep Disturbances Associated With Menopause
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Started Oct 2022
474 enrolled
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerHot Flashes
Worked on LYNKUET at Bayer? Share your interview experience or compensation data (+7 days Pro)
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.