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Premature Ejaculation

16
Pipeline Programs
9
Companies
10
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
7
2
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
2 programs
2
Tramadol HydrochloridePhase 31 trial
Tramadol Hydrochloride & PlaceboPhase 31 trial
Active Trials
NCT00983736Terminated1,050Est. Sep 2010
NCT00983151Terminated1,050Est. Sep 2010
Plethora Solutions
Plethora SolutionsUK - Chalgrove
3 programs
2
1
PSD502, contains a mixture of lidocaine and prilocainePhase 2/31 trial
Intervention APhase 11 trial
Intervention APhase 1
Active Trials
NCT01184105Completed30Est. Nov 2010
NCT00556478Completed256Est. Oct 2009
Shionogi
ShionogiJapan - Osaka
1 program
1
PSD502, contains a mixture of lidocaine and prilocainePhase 2/3
ViiV Healthcare
ViiV HealthcareNC - Durham
4 programs
2
2
16448Phase 2
GSK557296Phase 2
GSK958108Phase 1
GSK958108Phase 1
Biocorp
BiocorpFrance - Issoire
3 programs
1
2
CDFR0812-15/25mgPhase 21 trial
KH-001 ODTPhase 2
Intervention APhase 11 trial
Active Trials
NCT01183208Completed21Est. Feb 2010
NCT02571101Unknown297Est. Jun 2016
Dong-A ST
Dong-A STKorea - Seoul
1 program
1
DA-8031Phase 21 trial
Active Trials
NCT01798667Unknown220Est. Sep 2013
Kadence Bio
Kadence BioUK - London
1 program
1
KH-001 ODTPhase 21 trial
Active Trials
NCT07434271Recruiting40Est. Aug 2026
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
OnabotulinumtoxinAPhase 21 trial
Active Trials
NCT01917006Terminated59Est. Aug 2017
GSK
GSKLONDON, United Kingdom
1 program
16448PHASE_21 trial
Active Trials
NCT00537459Completed18

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bausch HealthTramadol Hydrochloride
Bausch HealthTramadol Hydrochloride & Placebo
Plethora SolutionsPSD502, contains a mixture of lidocaine and prilocaine
Kadence BioKH-001 ODT
BiocorpCDFR0812-15/25mg
AbbVieOnabotulinumtoxinA
Dong-A STDA-8031
GSK16448
Plethora SolutionsIntervention A
BiocorpIntervention A

Clinical Trials (10)

Total enrollment: 3,041 patients across 10 trials

NCT00983736Bausch HealthTramadol Hydrochloride

Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation

Start: Oct 2009Est. completion: Sep 20101,050 patients
Phase 3Terminated
NCT00983151Bausch HealthTramadol Hydrochloride & Placebo

Study to Evaluate Efficacy and Safety in Males Subjects With Premature Ejaculation

Start: Aug 2009Est. completion: Sep 20101,050 patients
Phase 3Terminated
NCT00556478Plethora SolutionsPSD502, contains a mixture of lidocaine and prilocaine

Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation

Start: Oct 2007Est. completion: Oct 2009256 patients
Phase 2/3Completed
NCT07434271Kadence BioKH-001 ODT

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

Start: Dec 2025Est. completion: Aug 202640 patients
Phase 2Recruiting
NCT02571101BiocorpCDFR0812-15/25mg

A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation

Start: Nov 2015Est. completion: Jun 2016297 patients
Phase 2Unknown
NCT01917006AbbVieOnabotulinumtoxinA

A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Start: Aug 2013Est. completion: Aug 201759 patients
Phase 2Terminated
NCT01798667Dong-A STDA-8031

Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

Start: Jan 2013Est. completion: Sep 2013220 patients
Phase 2Unknown
NCT00537459GSK16448

A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation

Start: Dec 200618 patients
Phase 2Completed
NCT01184105Plethora SolutionsIntervention A

A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation

Start: Sep 2010Est. completion: Nov 201030 patients
Phase 1Completed
NCT01183208BiocorpIntervention A

A Safety and Tolerability Study of Administration of PSD502

Start: Dec 2009Est. completion: Feb 201021 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 3,041 patients
9 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.