NCT07606664 Fezolinetant Hot Flashes Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07606664 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07606664 is a hot trial to watch
Hot Flashes is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07606664 is notable because it evaluates Fezolinetant in a Phase 3 design sponsored by University of Pittsburgh. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07606664 |
| Official title | Fezolinetant and Vascular Health and Brain Health (FAVES-B) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Fezolinetant |
| Sponsor | University of Pittsburgh |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Flow-Mediated Dilation |
| Endpoint time frame | Baseline and end of treatment at 12 weeks. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this clinical trial is to learn whether a study drug called fezolinetant impacts cardiovascular and cognitive health in women who have moderate to severe menopausal hot flashes and night sweats. Researchers will compare fezolinetant to a placebo. A placebo is a pill that looks like the study drug but does not contain any active medicine. This comparison helps researchers understand whether fezolinetant works better than no treatment. Participants will: Be randomly assigned to take either fezolinetant (45 mg) or a placebo once a day for 12 weeks. Visit the research clinic for regular checkups and tests during the study. Complete tests that measure blood vessel function and cognition. Participants and study staff will not know which treatment each participant receives during the study.
Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Flow-Mediated Dilation (Baseline and end of treatment at 12 weeks.) — Endothelial function assessed by flow-mediated dilation
- Verbal Memory Performance (Baseline and end of treatment at 12 weeks.) — Verbal memory neuropsychological test performance
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Fezolinetant is indexed as Small molecule drug, with target NK3, mechanism NK3 antagonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: University of Pittsburgh did not return an exact normalized organization match in this snapshot. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07606664 provides a focused lens on Hot Flashes development. Its value will be determined by whether Fezolinetant can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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