FDA Approves Veozah (Fezolinetant) for Menopause Hot Flashes

FDA Approves Veozah: New Non-Hormonal Menopause Treatment

Veozah, recently approved by the FDA, provides a non-hormonal option for managing menopause symptoms, marking a significant advancement in women's health.

Dr. Sarah Mitchell PharmD, RPh · Senior FDA Regulatory Correspondent

Reviewed by Dr. Sarah Chen Pharmaceutical Sciences Editor

Saturday, April 4, 2026 4 min read Updated Jul 6, 2026

The U.S. Food and Drug Administration (FDA) approved Veozah (fezolinetant) on May 12, 2023, as the first non-hormonal neurokinin 3 (NK3) receptor antagonist for treating moderate to severe vasomotor symptoms (hot flashes) caused by menopause. This approval gives women a new option when hormone therapy is not appropriate.

Key Takeaways

The FDA approved Veozah (fezolinetant) on May 12, 2023, for moderate to severe vasomotor symptoms due to menopause FDA.
It is the first non-hormonal NK3 receptor antagonist approved for this indication, offering an alternative to hormone therapy Astellas.
The approved dose is 45 mg taken once daily, with or without food.
Approval was based on the BRIGHT SKY Phase 3 program, which enrolled over 3,000 women across three trials ClinicalTrials.gov.
Liver function monitoring is required before and during treatment due to risk of elevated hepatic transaminases.

What Is Veozah and When Was It Approved?

Veozah (fezolinetant) is an oral medication developed by Astellas Pharma for treating vasomotor symptoms associated with menopause. The FDA granted approval on May 12, 2023, following a priority review. This approval marked a significant milestone as the first neurokinin 3 receptor antagonist cleared for use in menopausal women.

How Does Veozah Work?

Veozah works through a novel mechanism of action. It blocks neurokinin B (NKB) from binding to NK3 receptors located on KNDy neurons in the hypothalamus. These neurons play a central role in regulating the body's thermoregulatory center. During menopause, declining estrogen levels disrupt the balance between estrogen and NKB, leading to increased KNDy neuron activity and resulting in hot flashes. By antagonizing NK3 receptors, fezolinetant modulates this activity and reduces vasomotor symptoms without using hormones.

What Did the Clinical Trials Show?

The FDA approval was supported by data from the BRIGHT SKY Phase 3 program, which included three clinical trials:

SKYLIGHT 1 (NCT04003155): A 12-week trial with 527 participants evaluating efficacy and safety.
SKYLIGHT 2 (NCT04003142): A confirmatory 12-week trial with 501 participants.
SKYLIGHT 4 (NCT04003389): A 52-week safety extension study.

Together, these trials enrolled over 3,000 women across the United States, Canada, and Europe. The studies demonstrated that fezolinetant significantly reduced the frequency and severity of moderate to severe hot flashes compared to placebo, with improvements observed as early as week 1 and maintained through week 52.

What Is the Recommended Dosage?

The FDA approved Veozah at a dose of 45 mg taken orally once daily. Patients may take the medication with or without food. Both the 30 mg and 45 mg doses showed statistically significant reductions in vasomotor symptom frequency and severity at weeks 4 and 12 compared to placebo in the Phase 3 trials.

What Safety Information Should Patients Know?

The prescribing information for Veozah includes important safety considerations. The drug carries a warning for elevated hepatic transaminases, which can indicate liver injury. Healthcare providers should perform liver function tests before initiating treatment and periodically during therapy. Veozah is contraindicated in patients with severe hepatic impairment or those taking concomitant CYP1A2 inhibitors.

Who Should Consider Veozah?

Veozah offers a treatment option for menopausal women experiencing moderate to severe vasomotor symptoms who either cannot take hormone therapy or prefer a non-hormonal approach. Women with a history of stroke, heart attack, blood clots, or certain cancers may be candidates for this non-hormonal alternative.

What Is the Market Context for Veozah?

Veozah enters a treatment area where options have traditionally included hormone replacement therapies, gabapentin, and selective serotonin reuptake inhibitors. As the first NK3 receptor antagonist approved for this indication, it provides a new therapeutic class for patients seeking non-hormonal relief from menopausal hot flashes.

Frequently Asked Questions

What is Veozah approved to treat?

Veozah (fezolinetant) is approved to treat moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, associated with menopause. It is the first non-hormonal neurokinin 3 (NK3) receptor antagonist approved for this indication.

How does Veozah work?

Veozah works by blocking neurokinin B (NKB) from binding to NK3 receptors on KNDy neurons in the hypothalamus. These neurons regulate the body's thermoregulatory center. By antagonizing NK3 receptors, fezolinetant reduces the frequency and severity of hot flashes without using hormones.

What dose of Veozah was approved by the FDA?

The FDA approved Veozah at a dose of 45 mg taken orally once daily, with or without food. This dosage was selected based on Phase 3 clinical trial data from the SKYLIGHT program.

What clinical trials supported Veozah's FDA approval?

The FDA approval was based on the BRIGHT SKY Phase 3 program, which included three trials: SKYLIGHT 1 (NCT04003155), SKYLIGHT 2 (NCT04003142), and SKYLIGHT 4 (NCT04003389). These trials enrolled over 3,000 women and demonstrated significant reductions in hot flash frequency and severity compared to placebo.

What are the safety considerations for Veozah?

Veozah carries a warning for elevated hepatic transaminases (liver injury). Patients should undergo liver function testing before starting treatment and periodically during therapy. The drug is contraindicated in patients with severe hepatic impairment or those taking concomitant CYP1A2 inhibitors.

Primary Sources

U.S. Food and Drug Administration. FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. May 12, 2023.
Astellas Pharma. Astellas' VEOZAH (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause. May 13, 2023.
ClinicalTrials.gov. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause (SKYLIGHT 1). NCT04003155.
ClinicalTrials.gov. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 (SKYLIGHT 2). NCT04003142.
ClinicalTrials.gov. A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause (SKYLIGHT 4). NCT04003389.