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Hot Flashes

11
Pipeline Programs
13
Companies
22
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
4
4
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Astellas
VEOZAHApproved
fezolinetant
Astellas
Neurokinin 3 Receptor Antagonist [EPC]oral2023
4M Part D

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
1
Gabapentin, Estrogen and placebo administrationPhase 41 trial
EscitalopramN/A1 trial
Low-dose 17-ß-estradiol with progesterone taperN/A1 trial
Active Trials
NCT00894543Completed205Est. Jun 2010
NCT01418209Completed339Est. Jan 2013
NCT00276081Completed60Est. Sep 2004
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
Totelle®Phase 41 trial
PD-0299685Phase 21 trial
Active Trials
NCT00314964Completed527Est. Jul 2007
NCT00195520Completed100Est. Dec 2006
Bayer
BayerLEVERKUSEN, Germany
2 programs
1
1
Climara PROPhase 41 trial
MenostarPhase 31 trial
Active Trials
NCT00185237Completed165Est. Nov 2006
NCT00206622Completed425Est. Feb 2006
Astellas
AstellasChina - Shenyang
1 program
1
1
VEOZAH(fezolinetant)Phase 35 trials
Active Trials
NCT07455812Active Not Recruiting105Est. Jul 2026
NCT06049797Active Not Recruiting999Est. May 2026
NCT04793204Completed16Est. May 2021
+2 more trials
Noven Pharmaceuticals
2 programs
1
1
BrisdellePhase 31 trial
BrisdellePhase 21 trial
Active Trials
NCT00786188Completed102Est. Jun 2009
NCT01101841Completed570Est. Nov 2011
Alliance Pharmaceuticals
1 program
1
medroxyprogesteronePhase 31 trial
Active Trials
NCT00030914Completed227Est. Sep 2006
Fervent Pharmaceuticals
1 program
1
FP-101Phase 21 trial
Active Trials
NCT03285672Completed109Est. Oct 2018
Eppendorf
EppendorfGermany - Hamburg
1 program
Open Label PlaceboN/A1 trial
Active Trials
NCT03838523Completed100Est. Mar 2020
Coordination Pharmaceuticals
1 program
PolysomnographyN/A1 trial
Active Trials
NCT05892211Suspended30Est. Mar 2032
IQVIA
IQVIADURHAM, NC
1 program
FP-101PHASE_2
Teva
TevaIsrael - Petach Tikva
1 program
Cenestin 0.3 mg TabletsPHASE_31 trial
Active Trials
NCT00272935Completed400Est. May 2007

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
PfizerTotelle®
BayerClimara PRO
Human BioSciencesGabapentin, Estrogen and placebo administration
Astellasfezolinetant
Noven PharmaceuticalsBrisdelle
TevaCenestin 0.3 mg Tablets
BayerMenostar
Alliance Pharmaceuticalsmedroxyprogesterone
Fervent PharmaceuticalsFP-101
Noven PharmaceuticalsBrisdelle
PfizerPD-0299685
Astellasfezolinetant
Astellasfezolinetant
Astellasfezolinetant
Astellasfezolinetant

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 4,720 patients across 22 trials

Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Start: Dec 2004Est. completion: Dec 2006100 patients
Phase 4Completed
NCT00206622BayerClimara PRO

Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

Start: Dec 2004Est. completion: Feb 2006425 patients
Phase 4Completed
NCT00276081Human BioSciencesGabapentin, Estrogen and placebo administration

Gabapentin Versus Estrogen for the Treatment of Hot Flashes

Start: May 2002Est. completion: Sep 200460 patients
Phase 4Completed

A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause

Start: Jul 2020Est. completion: Jun 2022150 patients
Phase 3Completed

24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms

Start: Mar 2010Est. completion: Nov 2011570 patients
Phase 3Completed
NCT00272935TevaCenestin 0.3 mg Tablets

A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

Start: Dec 2005Est. completion: May 2007400 patients
Phase 3Completed

Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

Start: Jul 2005Est. completion: Nov 2006165 patients
Phase 3Completed

Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Start: Apr 2002Est. completion: Sep 2006227 patients
Phase 3Completed

FP-101 for the Treatment of Hot Flashes in Postmenopausal Women

Start: Mar 2018Est. completion: Oct 2018109 patients
Phase 2Completed

Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

Start: Nov 2008Est. completion: Jun 2009102 patients
Phase 2Completed

Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

Start: Aug 2006Est. completion: Jul 2007527 patients
Phase 2Completed

A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects

Start: Mar 2021Est. completion: May 202116 patients
Phase 1Completed

A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants

Start: Nov 2020Est. completion: Feb 202116 patients
Phase 1Completed

A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function

Start: Sep 2020Est. completion: Mar 202126 patients
Phase 1Completed

A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function

Start: Aug 2020Est. completion: Mar 202227 patients
Phase 1Completed

A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants

Start: Feb 2020Est. completion: Feb 202122 patients
Phase 1Completed

A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause

Start: Oct 2024Est. completion: Jul 2026105 patients
N/AActive Not Recruiting

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Start: Nov 2023Est. completion: May 2026999 patients
N/AActive Not Recruiting

LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes

Start: Dec 2020Est. completion: Mar 203230 patients
N/ASuspended
NCT03838523EppendorfOpen Label Placebo

Non-concealed Placebo Treatment for Menopausal Hot Flushes

Start: Feb 2019Est. completion: Mar 2020100 patients
N/ACompleted
NCT01418209Human BioSciencesLow-dose 17-ß-estradiol with progesterone taper

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms

Start: Nov 2011Est. completion: Jan 2013339 patients
N/ACompleted

MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

Start: Jul 2009Est. completion: Jun 2010205 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
13 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.