Veozah FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 1, 2024.
FDA Approved: Yes (First approved May 12, 2023)
Brand name: Veozah
Generic name: fezolinetant
Dosage form: Tablets
Company: Astellas Pharma US, Inc.
Treatment for: Menopausal Disorders, Hot Flashes
Veozah (fezolinetant) is a selective neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
- Vasomotor symptoms (VMS) are common symptoms of menopause, characterized by hot flashes (also called hot flushes) and/or night sweats. VMS can have a considerable effect on a woman's comfort and sleep, leading to anxiety, irritability, loss of productivity and depression, and potentially disrupting daily activities and impacting overall quality of life.
- Veozah is a neurokinin 3 (NK3) receptor antagonist that works to reduce the frequency and severity of hot flashes by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the temperature control center of the brain.
- Veozah tablets are taken orally once daily with or without food.
- Warnings and precautions associated with Veozah include elevations in hepatic transaminase concentrations and hepatotoxicity. Hepatic function should be evaluated prior to initiation of treatment. Follow-up hepatic laboratory tests should be performed monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy. Patients should discontinue Veozah treatment immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain).
- Common adverse reactions include abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
Development timeline for Veozah
Further information
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