Elinzanetant

LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes.

• LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.ICD-10: N95.1

• LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy [see Use in Specific Populations (8.1 , 8.3) ] .contraindicated

The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. ( 2.2 ) Swallow capsules whole. Do not cut, crush, or chew capsules. ( 2.2 ) See full prescribing information for LYNKUET dosage modification due to drug interactions. ( 2.3 ) 2.1 Recommended Evaluation and Testing Before Initiation of LYNKUET Exclude pregnancy in females of reproductive potential [see Contraindications (4) ], Warnings and Precautions (5.3) , and Use in Specific Populations (8.3) ]. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥ 2 times upper limit of normal (ULN) or if the total bilirubin is ≥ 2 times ULN [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.7) ]. 2.2 Recommended Dosage The recommended dosage of LYNKUET is 120 mg (two 60 mg capsules) orally once daily at bedtime at about the same time each day. If a dose is missed at bedtime, take the next dose as scheduled on the following day. Do not take two doses on the same day to make up for a missed dose. Take LYNKUET with or without food. Take LYNKUET with water and swallow capsules whole. Do not cut, crush or chew capsules. 2.3 Dosage Modifications for Drug Interactions Dosage modifications for concomitant use with specific drugs are provided in Table 1 [see Drug Interactions (7.1) ]. Table 1.

CNS Depressant Effect and Daytime Impairment: Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the upper limit of normal (ULN). Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN or if the total bilirubin is equal to or exceeds two times the ULN. Advise patients to discontinue LYNKUET immediately in case of signs or symptoms suggesting liver injury. ( 5.2 ) Risk of pregnancy loss: May cause pregnancy loss or stillbirth when administered during pregnancy. Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET. Discontinue if pregnancy is confirmed ( 5.3 ) Risk of seizures in patients with a history of seizures ( 5.4 ) 5.1 Central Nervous System (CNS) Depressant Effect and Daytime Impairment In the three OASIS trials, nervous system effects (including somnolence, fatigue, vertigo, dizziness and presyncope) occurred in 11.9% of patients on LYNKUET compared to 3.5% on placebo. [see also Adverse Reactions (6.1) ]. Advise patients about the potential for somnolence and other nervous system effects.

The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of LYNKUET was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3 ) in 1420 women . In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks. After the first 12 weeks, 341 women randomized to LYNKUET continued to receive LYNKUET for another 14 weeks, with a total treatment duration of up to 26 weeks. In OASIS 1 and OASIS 2 combined, 349 women received placebo for the first 12 weeks and 348 women switched to LYNKUET for the next 14 weeks. In OASIS 3, 627 women received LYNKUET or placebo for up to 52 weeks to evaluate long-term safety [see Clinical Studies (14) ] .

End Stage Renal Disease with or without hemodialysis: Not recommended. ( 8.6 ) Moderate to Severe Hepatic Impairment: Not recommended. ( 8.7 ) 8.1 Pregnancy Risk Summary LYNKUET is contraindicated in pregnancy [see Contraindications (4) ]. If pregnancy occurs during the use of LYNKUET, discontinue treatment. Based on findings from animal reproduction studies, LYNKUET may cause pregnancy loss or stillbirth but not fetal malformations when administered during pregnancy. There are no data on the use of LYNKUET in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in rats, an increase in total litter loss or stillbirth and a decrease of neonatal pup viability was observed within the range of human therapeutic exposure when dams were treated orally throughout gestation and lactation [i.e., gestation day 6 to lactation day 21]. There was an increase in percentage of pre- and post-implantation embryo loss and decrease in fetal body weights at 16-fold the human therapeutic exposure when rat dams were treated orally prior to mating and through the early embryonic period [i.e., 22 days before mating to post-coitum day 6].

Metabolism

Elinzanetant C max and AUC increased in a greater than dose-proportional manner (20% to 50%) over the dose range from 40 to 160 mg once daily (0.33 to 1.33 times the highest recommended dose). Elinzanetant steady state plasma concentrations were reached in 5 to 14 days after daily dosing.

There is no specific antidote for LYNKUET. In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

• Oct 24, 2025NDANDA219469Bayer Hlthcare

1. 1Somnolence2122%
2. 2Fatigue1313%
3. 3Dizziness1111%
4. 4Nausea99.3%
5. 5Headache77.2%
6. 6Incorrect Dose Administered77.2%
7. 7Product Use Issue77.2%
8. 8Hot Flush66.2%
9. 9Diarrhoea55.2%
10. 10Drug Ineffective55.2%
11. 11Palpitations55.2%
12. 12Dyspnoea44.1%
13. 13Hepatic Enzyme Increased44.1%
14. 14Migraine44.1%
15. 15Vertigo44.1%

The 10 most recently updated of 22 ClinicalTrials.gov registrations naming Elinzanetant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Finding Links Between Hot flASHes and CardioVascular Disease
  Recruiting · Phase 2 · Interventional · 80 enrolled · Massachusetts General Hospital
  NCT07077395updated 2026-05-20
• An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
  Not yet recruiting · Observational · 1,500 enrolled · Bayer
  NCT07490431updated 2026-05-18
• 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
  Active not recruiting · Phase 3 · Interventional · 474 enrolled · Bayer
  NCT05587296updated 2026-05-06
• A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause
  Completed · Phase 3 · Interventional · 396 enrolled · Bayer
  NCT05042362updated 2026-02-12
• A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
  Completed · Phase 3 · Interventional · 400 enrolled · Bayer
  NCT05099159updated 2026-02-12
• A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants
  Completed · Phase 1 · Interventional · 18 enrolled · Bayer
  NCT07229404updated 2026-01-27
• A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
  Completed · Phase 3 · Interventional · 628 enrolled · Bayer
  NCT05030584updated 2025-12-01
• A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
  Completed · Phase 2 · Interventional · 110 enrolled · Bayer
  NCT06112756updated 2025-11-10
• A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
  Completed · Phase 1 · Interventional · 31 enrolled · Bayer
  NCT05071729updated 2025-07-14
• A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
  Completed · Phase 1 · Interventional · 64 enrolled · Bayer
  NCT06219902updated 2024-05-08

Frequently asked questions

How does Elinzanetant work?

LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes.

What is Elinzanetant used for?

According to FDA labeling, Elinzanetant carries indications including: LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Elinzanetant?

Elinzanetant is classified as Other gynecologicals, Neurokinin 1 Antagonists, Neurokinin 3 Receptor Antagonists, Dynorphin Activity Alteration, Substance P Activity Alteration, Sympathetic Activity Alteration.

What are the brand names for Elinzanetant?

Elinzanetant is marketed under brand names including Lynkuet.

What are the contraindications for Elinzanetant?

Elinzanetant labeling lists contraindications including: LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy [see Use in Specific Populations (8.1 , 8.3) ] .. Always consult the full prescribing information and a clinician.