Rebecca Dunsmoor-Su, MD, highlights reduced hot flashes from cendifensine

In a recent interview with Contemporary OB/GYN, Rebecca Dunsmoor-Su, MD, discussed new phase 2 trial findings on cendifensine, an investigational therapy for menopausal hot flashes.

The study evaluated multiple doses of the medication and focused primarily on reductions in moderate to severe vasomotor symptoms. According to Dunsmoor-Su, all tested doses produced clinically meaningful improvements. By week 4, women taking the lower dose experienced an 82% reduction in moderate to severe hot flashes, and this improvement increased to 92% by week 12.

Symptom severity also declined significantly, with the lower dose reducing severity by about 42% at week 4 and 59% by week 12, while higher doses demonstrated even greater effects. These results suggest that cendifensine has a robust impact on both the frequency and intensity of hot flashes.

The significance of these findings lies in the drug’s novel mechanism of action. Unlike existing therapies, cendifensine targets the fundamental neural pathways that drive hot flashes. Dunsmoor-Su emphasized that hot flashes are often dismissed as a nuisance, yet they can exert substantial effects on quality of life, particularly by disrupting sleep and contributing to long-term health concerns. A treatment that works at the core physiological source of symptoms offers a promising new avenue for effective and comprehensive symptom relief.

Cendifensine differs from other menopause treatments in several key ways. Traditional menopausal hormone therapy works by replacing estrogen, thereby influencing the brain’s feedback signals that regulate temperature control. Other medications—such as certain SSRIs—were originally developed for different indications and later repurposed for hot flashes, though their mechanisms and efficacy are less clear.

More recently, neurokinin receptor antagonists such as fezolinetant (Veozah) have been developed to target KNDy neurons, which play a central role in triggering hot flashes. While these targeted therapies are effective, they primarily address vasomotor symptoms alone.

Cendifensine, in contrast, acts more broadly through the monoamine system, enhancing serotonin, norepinephrine, and dopamine signaling while also modulating KNDy neuron activity. This broader mechanism may allow it to address additional menopause-related symptoms—such as mood changes and food cravings—that accompany hot flashes for many women.

Looking ahead, Dunsmoor-Su noted that the next step is larger phase 3 trials to determine optimal dosing, confirm effectiveness, and further evaluate safety. Early studies revealed no major safety concerns, but larger sample sizes are essential for regulatory approval and for exploring whether cendifensine may benefit other menopause-related indications.

No relevant disclosures.

Reference

Noema Pharma announces phase 2a study results with cendifensine in women with vasomotor symptoms (hot flashes) due to menopause. Noema Pharma. November 6, 2025. Accessed December 3, 2025. https://noemapharma.com/2025/11/06/noema-pharma-announces-phase-2a-study-results-with-cendifensine-in-women-with-vasomotor-symptoms-hot-flashes-due-to-menopause/