A first-in-class non-hormonal option for menopausal hot flushes and night sweats – what pharmacists need to know.

The management of menopausal vasomotor symptoms (VMS), also known as hot flushes and night sweats, has traditionally centred on menopausal hormone therapy (MHT). However, some women either cannot or prefer not to use hormonal treatments, creating an unmet need for effective non-hormonal options. Until recently. most non-hormonal treatments for VMS were prescribed ‘off label’, that is, for a use that is different to those approved in the product information.                    

The recent introduction of Veoza^TM (fezolinetant) offers a novel, on-label, targeted approach to VMS treatment – which pharmacists are increasingly likely to encounter in practice.

A different mechanism: targeting thermoregulation, not hormones

Veoza represents a shift in how we conceptualise and treat VMS. It is a selective neurokinin 3 (NK3) receptor antagonist, working centrally to block neurokinin B (NKB) signalling in the hypothalamus.¹

During menopause, declining oestrogen levels lead to increased NKB activity within KNDy neurons, disrupting the thermoregulatory centre and triggering hot flushes.^1,2 By blocking this pathway, Veoza helps restore temperature stability without altering sex hormone levels,³ making it particularly relevant for women who are not suitable candidates for MHT.¹

Treatment of menopausal hot flushes and night sweats can therefore be achieved, either by replacing oestrogen (hormone replacement), or blocking the action of NKB on the thermoregulatory centre with receptor antagonists, such as Veoza.

Efficacy: clinically meaningful reductions in hot flushes and night sweats

In phase 3 trials (SKYLIGHT 1 and 2), Veoza 45 mg once-daily significantly reduced
both the frequency and severity of moderate-to-severe VMS versus placebo.^4,5

Improvements were seen as early as week 1 and sustained up to 52 weeks, with patients experiencing approximately 2–3 fewer hot flushes per day vs placebo. By week 12, around two-thirds of hot flushes were eliminated, with reduced severity in remaining episodes.^1,4 Veoza has also been shown to improve sleep and quality of life.

A systematic review and network meta-analysis comparing the efficacy of Veoza with MHT and non-hormonal therapies for treating menopausal VMS⁶ found that the effect of Veoza on VMS frequency was comparable to MHT – and more effective than other available non-hormonal agents. No head-to-head comparison trials have been conducted.

Veoza is generally well tolerated

Overall, Veoza has a favourable tolerability profile.¹ The most common adverse effects (≥1%) include:

• headache
• diarrhoea
• nausea
• insomnia
• fatigue.

Discontinuation rates in clinical trials were low, with liver enzyme elevation and insomnia the most frequent causes.¹

Liver enzyme elevations were observed in clinical trials, with ALT / AST  ≥3× ULN occurring in 2.7% of patients vs 1.4% with placebo.⁷ Post-marketing reports have also identified rare but serious and reversible hepatotoxicity, sometimes within 40 days of treatment initiation.¹ As such, Baseline LFTs are required before initiation, monthly for 3 months, then at 6 and 9 months.

Dosing and practical use

Veoza is administered once daily, around the same time with or without food, and should be swallowed whole. Steady-state levels are reached quickly (within ~2 days), and no dose adjustment is required for mild-to-moderate renal impairment. Veoza is primarily metabolised by CYP1A2, and concomitant use with moderate or strong CYP1A2 inhibitors is contraindicated.

Where pharmacists add value

Pharmacists are uniquely positioned at the point of prescribing, dispensing and among patients self-managing symptoms with OTC options.

Key contributions include:

• identifying appropriate patients – those who cannot or prefer not to use MHT
• providing reassurance – positioning monitoring as safety-driven rather
  than alarming
• medication review – screening for potential interactions with moderate
  to strong CYP1A2 inhibitors
• bridging OTC and prescription care – recognising when women with persistent symptoms may benefit from escalation and refer them to their GP.

Veoza is more than just another prescription – it is an opportunity to improve access to effective therapy, support informed decision-making,
and play a central role in modern menopause management.

For pharmacists, the opportunity lies not just in dispensing, but in connecting patients to appropriate care, supporting treatment confidence, and improving outcomes in a historically under-treated area.

References

1. Australian Product Information – VEOZA™ (fezolinetant). 
2. Rance N, et al. Front. Neuroendocrinol. 2013;34 :211-27-Hall S et al.
3. Prague J, Abbara A, Comninos A et al. NK3 receptor antagonists do not increase FSH or estradiol secretion in postmenopausal women. J Endocr. Soc. 2019;4(2): bvz009 
4. Lederman S, et al. Lancet 2023; 401:1091-102. 
5. Johnson KA, et al. J Clin Endocrinol Metab 2023;108:1981-97. 
6. Morga A, et al. Menopause 2024;31:68-76
7. Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated with Menopause: A Randomized Controlled Trial. Obstet Gynecol 2023; 141:737-47.

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Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road, Macquarie Park, NSW 2113

MAT-AU-VEO-2026-00054 | June 2026

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked
to report any suspected adverse events at: www.tga.gov.au/safety/reporting-problems

Veoza Product Information is available here: https://rss.medsinfo.com.au/ax/pi.cfm?product=axpveoza