Chemistry:Elinzanetant

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Elinzanetant, sold under the brand name Lynkuet, is a medication used for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.[1] It is taken orally.[1]

The drug acts as a selective neurokinin NK1 and NK3 receptor antagonist.[1][2]

Elinzanetant was approved for medical use in the United States in October 2025.[3] The US Food and Drug Administration considers it to be a first-in-class medication.[4][5]

Medical uses

Elinzanetant is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.[1]

Pharmacology

Pharmacodynamics

Elinzanetant has been found to dose-dependently suppress luteinizing hormone, estradiol, and progesterone levels in premenopausal women.[6][7]

History

Elinzanetant was developed by Bayer Healthcare.[1]

The US Food and Drug Administration approved elinzanetant based on evidence from three clinical studies (OASIS-1 [NCT05042362], OASIS-2 [NCT05099159], and OASIS-3 [NCT05030584]) involving 1,423 participants.[3] Of these participants, 1,420 received treatment with either elinzanetant 120 mg or placebo during the studies.[3]

These trials were conducted at 267 clinical sites in 21 countries, with OASIS-1 taking place in 89 centers in nine countries (Austria, Czech Republic, Greece, Hungary, Israel, Italy, Netherlands, and the United States), OASIS-2 in 95 centers in 10 countries (Canada, Czech Republic, Germany, Italy, Norway, Poland, Portugal, Slovakia, Switzerland, and the United States), and OASIS-3 in 83 centers in nine countries (Belgium, Bulgaria, Canada, Denmark, Finland, Poland, Spain, the United Kingdom, and the United States).[3]

OASIS-1 and OASIS-2 were used to assess the efficacy of elinzanetant.[3] OASIS-1, OASIS-2, and OASIS 3 were used to assess the safety of elinzanetant.[3] Only OASIS-3 was placebo-controlled for the duration of 52 weeks.[3]

Society and culture

Elinzanetant was approved for medical use in the United States in October 2025.[4][8]

In September 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lynkuet, intended for the treatment of moderate to severe vasomotor symptoms (hot flushes).[2] The applicant for this medicinal product is Bayer AG.[2] Elinzanetant was authorized for medical use in the European Union in November 2025.[2][9]

Names

Elinzanetant is the international nonproprietary name.[10]

Elinzanetant is sold under the brand name Lynkuet.[11]

Research

In addition to approval for vasomotor symptoms, elinzanetant is under development for the treatment of sleep disorders.[12] It is in phase 2 clinical trials for this indication.[12] The drug was also under development for the treatment of schizophrenia and opioid-related disorders, but development was discontinued for these uses.[12]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid <ref> tag; no text was provided for refs named Lynkuet FDA label
  2. ↑ 2.0 2.1 2.2 2.3 "Lynkuet EPAR". 19 September 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/lynkuet.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 "Drug Trials Snapshots: Lynkuet". 24 October 2025. https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-lynkuet.  Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ 4.0 4.1 "Novel Drug Approvals for 2025". 8 July 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. 
  5. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (PDF). January 2026. https://www.fda.gov/media/190705/download. 
  6. ↑ "Fezolinetant in the treatment of vasomotor symptoms associated with menopause". Expert Opin Investig Drugs 30 (7): 681–694. July 2021. doi:10.1080/13543784.2021.1893305. PMID 33724119. 
  7. ↑ "Elinzanetant (NT-814), a Neurokinin 1,3 Receptor Antagonist, Reduces Estradiol and Progesterone in Healthy Women". The Journal of Clinical Endocrinology and Metabolism 106 (8): e3221–e3234. July 2021. doi:10.1210/clinem/dgab108. PMID 33624806. 
  8. ↑ "Elinzanetant: First Approval". Drugs. November 2025. doi:10.1007/s40265-025-02244-3. PMID 41222830. 
  9. ↑ "Lynkuet PI". 18 November 2025. https://ec.europa.eu/health/documents/community-register/html/h1991.htm. 
  10. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information 34 (3). 2020. 
  11. ↑ "Bayer's Lynkuet (elinzanetant), the First and Only Neurokinin 1 and Neurokinin 3 Receptor Antagonist, Receives FDA Approval for Moderate to Severe Hot Flashes Due to Menopause" (Press release). Bayer. 24 October 2025. Retrieved 29 October 2025 – via Business Wire.
  12. ↑ 12.0 12.1 12.2 "Elinzanetant". 24 November 2025. https://adisinsight.springer.com/drugs/800044912. 
  • Clinical trial number NCT05042362 for "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-1)" at ClinicalTrials.gov
  • Clinical trial number NCT05099159 for "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)" at ClinicalTrials.gov
  • Clinical trial number NCT05030584 for "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 (OASIS-3)" at ClinicalTrials.gov



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