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Veoza (fezolinetant)
Published
Product name
Veoza
Active ingredient
Fezolinetant
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Veoza (fezolinetant) was approved for the following therapeutic use:
Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
How this medicine works
Certain nerve cells that form the temperature control centre in the brain (the KNDy neurons) are inhibited by the hormone oestrogen and stimulated by a chemical messenger made by neurons called neurokinin B. Prior to menopause, the opposing activities of oestrogen and neurokinin B keep these neurons in balance. When oestrogen levels start to decline at the onset of menopause, this balance is disrupted, leaving neurokinin B unopposed. This ultimately leads to altered activity in the KNDy neurons resulting in the symptoms of VMS (hot flashes and night sweats). Veoza (fezolinetant) blocks neurokinin B binding to KNDy neurons, preventing this imbalance from altering KNDy activity that causes VMS symptoms.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Veoza was considered favourable for the therapeutic use approved.