Registered South Africa · SAHPRA

VEOZA 45 mg

FEZOLINETANT

59/21.13/0510 INN generic

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Registration & product details

Registration no.
59/21.13/0510
Registration date
2026/06/23
Expiry date
-
Status
Registered
Active ingredient
FEZOLINETANT
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Astellas Pharma (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-08-27 10:17:28 · updated 2026-10-28 04:13:08

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

Molecular reference: fezolinetant

PubChem CID 117604931

Molecular formula: C16H15FN6OS

Mechanism of action

Fezolinetant 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.

Pharmacodynamics

Fezolinetant has a high affinity for the NK3 receptor (K<sub>i</sub> value of 19.9 to 22.1 nmol/L), which is more than 450-fold higher than the binding affinity for NK1 or NK2 receptors. Treatment with fezolinetant did not show any clear trends in sex hormones measured (follicle-stimulating hormone, testosterone, estrogen, and dehydroepiandrosterone sulfate) in menopausal women. A transient decrease of luteinizing hormone (LH) levels was observed at peak concentrations of fezolinetant. At a dose 20 times the maximum approved recommended dose, fezolinetant does not prolong the QT interval to any clinically relevant extent. In a phase 2a clinical trial, fezolinetant 90 mg BID significantly reduce the frequency and severity of vasomotor symptoms in postmenopausal women by more than 50%. The improvement was observed as early as in the first week of treatment and was maintained throughout the 12 weeks of treatment.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.