Fezolinetant's safety, pharmacokinetics, and therapeutic efficacy have been evaluated in multiple Phase 1, Phase 2, and Phase 3 clinical trials primarily targeting menopausal vasomotor symptoms and hot flashes, alongside studies in healthy volunteers, cardiovascular cohorts, patients with renal or hepatic impairment, and prostate cancer. These trials—spanning completed, recruiting, active not recruiting, not yet recruiting, and terminated statuses—are predominantly sponsored by commercial developers such as Astellas Pharma and Ogeda S.A., as well as academic institutions including the University of Colorado, Denver.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07606664 | NOT_YET_RECRUITING | Menopause Hot Flashes |
Rebecca Thurston |
2026-09-25 | PHASE3 |
| NCT06975111 | RECRUITING | Menopause; Menopause Hot Flashes; Menopause Related Conditions; Cardiovascular |
University of Colorado, Denver |
2026-03-01 | PHASE2; PHASE3 |
| NCT06957691 | RECRUITING | Prostate Cancer; Prostate Cancer (Adenocarcinoma); Prostate Cancer Metastatic Disease; Prostate Cancer Recurrent; Prostate Carcinoma; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer With Bone Metastasis; Vasomotor Disturbance; Vasomotor Symptoms; Vasomotor Symptoms (VMS); Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Vasomotor Symptoms; Hot Flashes; Androgen Deprivation Therapy; Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma; Androgen-deprivation Therapy; Hot Flashes; Hot Flushes; Hot Flushes and/or Sweats |
Shehzad Basaria, M.D. |
2026-01-14 | PHASE2 |
| NCT06917313 | RECRUITING | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
Yale University |
2025-12-05 | PHASE2 |
| NCT07568236 | NOT_YET_RECRUITING | Vasomotor Symptoms; Prostate Cancer |
Chinese University of Hong Kong |
2026-07-01 | PHASE2 |
| NCT07783282 | NOT_YET_RECRUITING | Prostate Cancer |
Astellas Pharma Global Development, Inc. |
2026-08-31 | PHASE1 |
| NCT06972875 | RECRUITING | Prostate CA; Androgen Deprivation Therapy |
University of Vermont |
2025-12-18 | PHASE2 |
| NCT06440967 | ACTIVE_NOT_RECRUITING | Hot Flashes |
Astellas Pharma Global Development, Inc. |
2024-07-31 | PHASE3 |
| NCT06206421 | COMPLETED | Hot Flashes |
Astellas Pharma Inc |
2024-02-22 | PHASE3 |
| NCT06812754 | COMPLETED | Hot Flashes |
Astellas Pharma Global Development, Inc. |
2025-03-10 | PHASE2 |
| NCT06206408 | COMPLETED | Hot Flashes |
Astellas Pharma Inc |
2024-02-16 | PHASE3 |
| NCT06617455 | TERMINATED | Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Ductal Carcinoma In Situ; Localized Breast Carcinoma |
University of Michigan Rogel Cancer Center |
2024-10-31 | PHASE2 |
| NCT06206421 | Recruiting | Hot Flashes |
Astellas Pharma Inc |
2024-02-22 | Phase 3 |
| NCT06206408 | Recruiting | Hot Flashes |
Astellas Pharma Inc |
2024-02-16 | Phase 3 |
| NCT05033886 | COMPLETED | Vasomotor Symptoms |
Astellas Pharma Global Development, Inc. |
2021-11-08 | PHASE3 |
| NCT05034042 | COMPLETED | Hot Flashes |
Astellas Pharma Inc |
2021-11-17 | PHASE2 |
| NCT04451226 | COMPLETED | Hot Flashes |
Astellas Pharma China, Inc. |
2020-07-30 | PHASE3 |
| NCT04234204 | COMPLETED | Hot Flashes |
Astellas Pharma China, Inc. |
2020-03-17 | PHASE3 |
| NCT04476849 | COMPLETED | Healthy Volunteers; Renal Impairment |
Astellas Pharma Global Development, Inc. |
2020-08-10 | PHASE1 |
| NCT04003389 | COMPLETED | Hot Flashes |
Astellas Pharma Global Development, Inc. |
2019-07-10 | PHASE3 |
| NCT04793204 | COMPLETED | Healthy Volunteers |
Astellas Pharma China, Inc. |
2021-03-24 | PHASE1 |
| NCT04482270 | COMPLETED | Hepatic Impairment; Healthy Volunteers |
Astellas Pharma Global Development, Inc. |
2020-09-02 | PHASE1 |
| NCT04793204 | Completed | Healthy Volunteers |
Astellas Pharma China Inc.|Astellas Pharma Inc |
2021-03-24 | Phase 1 |
| NCT04277624 | COMPLETED | Healthy Volunteers |
Astellas Pharma Global Development, Inc. |
2020-02-20 | PHASE1 |
| NCT04641260 | COMPLETED | Healthy Subjects |
Astellas Pharma Global Development, Inc. |
2020-11-20 | PHASE1 |
| NCT04641260 | Completed | Healthy Subjects |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2020-11-20 | Phase 1 |
| NCT04003155 | COMPLETED | Hot Flashes |
Astellas Pharma Global Development, Inc. |
2019-07-11 | PHASE3 |
| NCT04482270 | Completed | Hepatic Impairment|Healthy Volunteers |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2020-09-02 | Phase 1 |
| NCT04476849 | Completed | Healthy Volunteers|Renal Impairment |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2020-08-10 | Phase 1 |
| NCT04003142 | COMPLETED | Hot Flashes |
Astellas Pharma Global Development, Inc. |
2019-07-10 | PHASE3 |
| NCT03192176 | COMPLETED | Menopause; Hot Flashes |
Astellas Pharma Global Development, Inc. |
2017-07-19 | PHASE2 |
| NCT05419908 | COMPLETED | Hot Flashes |
Ogeda S.A. |
2015-09-21 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
Check the
Fezolinetant
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.