Elinzanetant

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Elinzanetant
Clinical data
Trade namesLynkuet
Other namesBAY-3427080; GSK-1144814; NT-814
License data
Routes of
administration		By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
  • N-[6-[(7S,9aS)-7-(hydroxymethyl)-3,4,6,7,9,9a-hexahydro-1H-pyrazino[2,1-c][1,4]oxazin-8-yl]-4-(4-fluoro-2-methylphenyl)pyridin-3-yl]-2-[3,5-bis(trifluoromethyl)phenyl]-N,2-dimethylpropanamide
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC33H35F7N4O3
Molar mass668.657 g·mol−1
3D model (JSmol)
  • CC1=C(C=CC(=C1)F)C2=CC(=NC=C2N(C)C(=O)C(C)(C)C3=CC(=CC(=C3)C(F)(F)F)C(F)(F)F)N4C[C@H]5COCCN5C[C@H]4CO
  • InChI=1S/C33H35F7N4O3/c1-19-9-23(34)5-6-26(19)27-13-29(44-16-25-18-47-8-7-43(25)15-24(44)17-45)41-14-28(27)42(4)30(46)31(2,3)20-10-21(32(35,36)37)12-22(11-20)33(38,39)40/h5-6,9-14,24-25,45H,7-8,15-18H2,1-4H3/t24-,25-/m0/s1
  • Key:DWRIJNIPBUFCQS-DQEYMECFSA-N

Elinzanetant, sold under the brand name Lynkuet, is a medication used for the treatment of moderate to severe vasomotor symptoms due to menopause.[4] It is an neurokinin 1 and neurokinin 3 receptor antagonist.[4] It was developed by Bayer Healthcare.[4] It is taken by mouth.[4]

Elinzanetant is a non-hormonal, selective, neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist.[5] By blocking NK-1 and NK-3 receptors signaling, elinzanetant is postulated to normalize neuronal activity involved in thermo- and sleep regulation in the hypothalamus.[5]

Medical uses

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Elinzanetant is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.[4]

Society and culture

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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).[5] The applicant for this medicinal product is Bayer AG.[5]

Lynkuet was approved for medical use in the United States in October 2025.[6]

Names

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Elinzanetant is the international nonproprietary name.[7]

Elinzanetant is sold under the brand name Lynkuet.[8]

References

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  1. ^ "Details for: Lynkuet". Drug and Health Products Portal. 23 July 2025. Retrieved 28 September 2025.
  2. ^ "Lynkuet product information". Lynkuet. 23 July 2025. Retrieved 28 September 2025.
  3. ^ "MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause". Medicines and Healthcare products Regulatory Agency (Press release). 8 July 2025. Retrieved 28 September 2025.
  4. ^ a b c d e f https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf
  5. ^ a b c d "Lynkuet EPAR". European Medicines Agency (EMA). 19 September 2025. Retrieved 27 September 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 24 October 2025. Retrieved 29 October 2025.
  7. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
  8. ^ "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.
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  • 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


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