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Molecule

Elinzanetant

Available on request
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Elinzanetant is a prescription medicine indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is available as capsules for oral use. MedsAcross supplies Elinzanetant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
G02CX07 Elinzanetant · Other gynaecological medicines, subgroup G02C, subgroup G02CX
US FDA first approval
24 October 2025
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule
Identifiers
UNII NZW2BOW35NCAS 929046-33-3DrugBank DB18968Q108453435

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

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. Elinzanetant has higher affinity for human NK1 receptors (pKi values of 8.7 to 10.2) and NK3 receptors (pKi values of 8.0 to 8.8) than for human NK2 receptors (pKi values of approximately 6.0).

Source: US FDA prescribing information

Dosing overview

The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. Swallow capsules whole. Do not cut, crush, or chew capsules. See full prescribing information for LYNKUET dosage modification due to drug interactions.

Source: US FDA prescribing information

Contraindications

LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy. Pregnancy.

Source: US FDA prescribing information

Warnings and precautions

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. 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) or if the total bilirubin is equal to or exceeds two times the ULN. Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation. Advise patients to discontinue LYNKUET immediately in case of signs or symptoms suggesting liver injury. Risk of pregnancy loss: May cause pregnancy loss or stillbirth when administered during pregnancy.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment Hepatic Transaminase Elevations Risk of Seizure The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence.

Source: US FDA prescribing information

Interactions

Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use with LYNKUET. Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily. 21 Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET.

Source: US FDA prescribing information

Storage

Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). Store the remaining capsule in the original blister card in the carton until the next dose.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Elinzanetant, sorted by availability.

MedicineManufacturerRegisterAvailability
Lynkuet 60 mg capsuleOralBayer HealthCare PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 24 October 2025Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Elinzanetant available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Elinzanetant and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Elinzanetant have?

The catalogue lists 1 brand names for Elinzanetant, including Lynkuet.

Is Elinzanetant approved by the US FDA?

Yes. The US FDA first approved Elinzanetant on 24 October 2025, according to Drugs@FDA.

Is Elinzanetant authorised in the European Union?

Yes. Elinzanetant has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Elinzanetant need cold chain shipping?

No listed presentation of Elinzanetant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Elinzanetant in?

Elinzanetant is classified under ATC code G02CX07 (Elinzanetant).

References

  1. LYNKUET prescribing information (Bayer HealthCare Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 16 June 2026
  2. Lynkuet: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 September 2026

Request Elinzanetant for export supply

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