Drug

Elinzanetant

Approved medicine

ClassNeurokinin 3 receptor antagonistResearchOngoing clinical research

Also known as Lynkuet, 2-(3,5-bis(trifluoromethyl)phenyl)-n-(4-(4-fluoro-2-methylphenyl)-6-((7s,9as)-7-(hydroxymethyl)hexahydropyrazino(2,1-c)(1,4)oxazin-8(1h)-yl)-3-pyridinyl)-n,2-dimethylpropanamide, Benzamide, 3-(5-methyl-2-tbenzeneacetamide, n-(4-(4-fluoro-2-methylphenyl)-6-((7s,9as)-hexahydro-7-(hydroxymethyl)pyrazino(2,1-c)(1,4)oxazin-8(1h)-yl)-3-pyridinyl)-n,.alpha.,.alpha.-trimethyl-3,5-bis(trifluoromethyl)-.

RxNorm2725511 ChEMBLCHEMBL4802157UNIINZW2BOW35N

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 3.5 Years in Women With Hormone-receptor Positive Breast Cancer:

Clinical trial2026-07-09Results posted · ClinicalTrials.gov

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

Clinical trial2026-02-12Results posted · ClinicalTrials.gov

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

Clinical trial2026-02-12Results posted · ClinicalTrials.gov

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women

Clinical trial2025-12-01Results posted · ClinicalTrials.gov

Approval: Lynkuet (EMA)

Regulatory2025-11-17EMA

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Clinical trial2025-11-10Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women

Clinical trial2024-04-15Completed · ClinicalTrials.gov

A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants

Clinical trial2023-04-28Completed · ClinicalTrials.gov

A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause

Clinical trial2023-03-10Results posted · ClinicalTrials.gov

Open-label, Fixed Sequence Crossover Study to Determine the Effects of a Single Dose of Elinzanetant (BAY 3427080) on the Pharmacokinetics of Dabigatran Etexilate in Healthy Participants

Clinical trial2022-11-14Completed · ClinicalTrials.gov

Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Elinzanetant in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal Function

Clinical trial2022-10-19Completed · ClinicalTrials.gov

A Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of Elinzanetant in Chinese Healthy Female Participants 40 to 65 Years of Age

Clinical trial2022-07-11Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Elinzanetant

Aliases & brands

Lynkuet2-(3,5-bis(trifluoromethyl)phenyl)-n-(4-(4-fluoro-2-methylphenyl)-6-((7s,9as)-7-(hydroxymethyl)hexahydropyrazino(2,1-c)(1,4)oxazin-8(1h)-yl)-3-pyridinyl)-n,2-dimethylpropanamideBenzamide, 3-(5-methyl-2-tbenzeneacetamide, n-(4-(4-fluoro-2-methylphenyl)-6-((7s,9as)-hexahydro-7-(hydroxymethyl)pyrazino(2,1-c)(1,4)oxazin-8(1h)-yl)-3-pyridinyl)-n,.alpha.,.alpha.-trimethyl-3,5-bis(trifluoromethyl)-

RxNorm CUI

2725511

ChEMBL ID

CHEMBL4802157

UNII

NZW2BOW35N

Primary mechanism

Neurokinin 3 receptor antagonist

Regulatory jurisdictions

ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Neuromedin-K receptor

TACR3 · P29371

ANTAGONISTNeurokinin 3 receptor antagonist

Substance-P receptor

TACR1 · P25103

ANTAGONISTNeurokinin 1 receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2025-11-17

Latest approval

2025-11-17

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2025-11-17Approval

Approval: Lynkuet (EMA)

Indication: Treatment of moderate to severe vasomotor symptoms (VMS).

Evidence ↗