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Molecule

Fezolinetant

Neurokinin 3 Receptor Antagonist
Available on request
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Fezolinetant is a neurokinin 3 receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. It is available as tablets for oral use. MedsAcross supplies Fezolinetant 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

Pharmacological class
Neurokinin 3 Receptor Antagonist, Neurokinin 3 Receptor Antagonists
ATC classification
G02CX06 Fezolinetant · Other gynaecological medicines, subgroup G02C, subgroup G02CX
US FDA first approval
12 May 2023
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 83VNE45KXXCAS 1629229-37-3DrugBank DB15669Q27269455

Clinical information

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

Uses

VEOZAH ® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. VEOZAH is a 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

VEOZAH is a neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center. Fezolinetant has high affinity for the NK3 receptor (Ki value of 19.9 to 22.1 nmol/L), which is more than 450-fold higher than binding affinity to NK1 or NK2 receptors.

Source: US FDA prescribing information

Dosing overview

One 45 mg tablet orally once daily with or without food. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury before beginning VEOZAH. While using VEOZAH, perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy or when signs or symptoms suggest liver injury.

Source: US FDA prescribing information

Contraindications

VEOZAH is contraindicated in women with any of the following conditions: • Known cirrhosis. • Severe renal impairment or end-stage renal disease. • Concomitant use with CYP1A2 inhibitors. • Known cirrhosis. • Severe renal impairment or end-stage renal disease. • Concomitant use with CYP1A2 inhibitors

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (risks of hepatotoxicity): Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting. • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. Hepatotoxicity: Cases of hepatotoxicity and jaundice have been reported in the postmarketing setting. Perform hepatic laboratory tests prior to initiation of VEOZAH to evaluate for hepatic function and injury. Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed elsewhere in the labeling: • Hepatic Transaminase Elevation and Hepatotoxicity. The most common adverse reactions with VEOZAH [at least 2% in VEOZAH 45 mg and greater than placebo] are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.

Source: US FDA prescribing information

Interactions

Effect of Other Drugs on VEOZAH CYP1A2 Inhibitors VEOZAH is a substrate of CYP1A2. Concomitant use of VEOZAH with drugs that are weak, moderate, or strong CYP1A2 inhibitors, increase the plasma C max and AUC of VEOZAH. VEOZAH is contraindicated in individuals using CYP1A2 inhibitors.

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 Fezolinetant, sorted by availability.

MedicineManufacturerRegisterAvailability
Veozah 45 mg tabletOralAstellas PharmaUS 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 12 May 2023Drugs@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 Fezolinetant available for export from India?

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

What brand names does Fezolinetant have?

The catalogue lists 1 brand names for Fezolinetant, including Veozah.

Is Fezolinetant approved by the US FDA?

Yes. The US FDA first approved Fezolinetant on 12 May 2023, according to Drugs@FDA.

Is Fezolinetant authorised in the European Union?

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

Does Fezolinetant need cold chain shipping?

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

Which ATC class is Fezolinetant in?

Fezolinetant is classified under ATC code G02CX06 (Fezolinetant).

References

  1. VEOZAH prescribing information (Astellas Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 26 February 2026
  2. Veoza: European public assessment report (EPAR). European Medicines Agency. Retrieved 21 August 2026

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