NDAORALCAPSULE
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
4/8 — Partial
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYNKUET (elinzanetant) is a small-molecule oral capsule approved by the FDA in October 2025 as an NDA from Bayer. The mechanism of action and specific therapeutic indication have not been disclosed in available data. Patient population and clinical use case remain to be clarified pending label information.
Launch18.6 years to LOE
Early-stage launch phase with significant runway ahead; commercial infrastructure still ramping, creating demand for field, marketing, and managed markets roles.
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 (19)
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 Nov 2026
1,500 enrolled
Vasomotor Symptoms (VMS) Associated With Menopause
Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
Started Jul 2026
100 enrolled
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women
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
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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.