Dec 07, 2025

Cendifensine Shows Dramatic Hot Flash Reduction in Phase 2 Trial

A Promising New Non-Hormonal Menopause Treatment

What Happened

A Phase 2a study of Noema Pharma’s experimental drug Cendifensine (formerly NOE-115) announced on November 6, 2025, shows dramatic reductions in menopausal hot flashes and night sweats.

In the 12-week open-label trial (NOE-PPM-201), menopausal women receiving 30 mg or 60 mg daily reported a mean 92.3% reduction in the number of moderate-to-severe vasomotor symptoms (VMS, i.e. hot flashes) by week 12.

Symptom severity also fell: VMS severity dropped by nearly 60% by week 12 in the study. Importantly, participants described improvements not only in hot flashes but also in associated menopause-related symptoms like mood, fatigue, food cravings, and even modest weight loss.

In an interview with Contemporary OB/GYN, investigator Rebecca Dunsmoor‑Su, MD highlighted that across all tested doses, women experienced clinically meaningful relief — as early as week 4, with continued improvement through week 12.

Why It Matters

For many women, hot flashes and night sweats are among the most disruptive symptoms of menopause, often waking them from sleep, affecting mood, concentration, and overall quality of life. Traditional treatments have included hormone therapy (HT) or neurokinin-3 receptor antagonists — but neither is ideal for every woman.

Cendifensine represents a novel, non-hormonal, broad-spectrum approach, targeting central nervous system pathways including serotonin, norepinephrine, and dopamine — potentially offering relief not just for hot flashes, but for a broader cluster of menopause-related symptoms (mood swings, fatigue, cravings, weight changes).

If further trials confirm safety and effectiveness, this could provide a new and attractive option for women who: cannot or prefer not to use hormones; have mixed symptom burdens; or want a more holistic approach to menopause relief.

What This Means for Women in Perimenopause & Menopause

Women suffering from frequent, moderate-to-severe hot flashes (or night sweats) may soon have a non-hormonal pill option that delivers strong relief.
Because Cendifensine also showed improvements in mood, fatigue, cravings, and even weight, it could help women whose menopausal symptoms go beyond just VMS — offering a more comprehensive symptom relief package.
For those reluctant or unable to use hormone therapy (past cancer, clot risk, other contraindications), this could represent an important new alternative.

Access & Availability

Currently, Cendifensine is investigational. The 2025 Phase 2a results are promising, but the drug is not yet approved for general use.
The next step will likely be Phase 2b or Phase 3 trials to confirm safety, optimal dosing, and long-term effects.
For now, the drug is only accessible in a research setting — not yet available by prescription or over the counter.

Benefits & Risks

Potential Benefits

Very substantial reduction in hot flash frequency and severity.
Possible additional relief from mood swings, fatigue, cravings, weight changes — addressing more than just VMS.
Non-hormonal mechanism, which may offer benefits for women who cannot (or choose not to) use hormone therapy.

Known/Reported Risks & Unknowns

In the Phase 2a trial, treatment was described as “generally well tolerated.” No serious adverse events were reported.
Because it’s early-stage research, long-term safety, side effects, and effectiveness have not yet been established.
As with any new therapy, optimal dosing and how it interacts with other medications remain to be determined.

Next Steps / What to Watch For

Watch for Phase 2b or Phase 3 trials from Noema Pharma to confirm safety and efficacy.
Monitor for any peer-reviewed publications and larger, placebo-controlled studies (the 2025 trial was open-label).
Once approved, consider how this treatment could fit into individualized menopause plans — especially for those seeking non-hormonal, multi-symptom relief.
Keep an eye on updates from menopause research and regulatory bodies for coverage, guidance, and long-term data.

What This Means for Your Midlife Health

Cendifensine’s promising Phase 2a data offers real hope for a new, non-hormonal path to relief — and one that may touch on many of the symptoms that make menopause tough. For women feeling stuck between limited options or wary of hormone therapy, this emerging therapy could broaden choices and restore quality of life. We’ll continue to follow the research so you’re among the first to know when (and if) it becomes widely available.