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Sexual Dysfunctions, Psychological

15
Pipeline Programs
2
Companies
14
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
1
0
1
0
12
1
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Sprout Pharmaceuticals
ADDYIApproved
flibanserin
Sprout Pharmaceuticals
oral2015

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Sprout Pharmaceuticals
13 programs
1
12
1
50 mg qhsPhase 31 trial
FlibanserinPhase 31 trial
FlibanserinPhase 31 trial
FlibanserinPhase 31 trial
FlibanserinPhase 31 trial
+8 more programs
Active Trials
NCT01188603Completed24Est. Oct 2010
NCT00491829Completed945Est. Mar 2009
NCT00441558Terminated1,723Est. Aug 2009
+10 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
sildenafilPhase 21 trial
Active Trials
NCT00746967Completed267Est. Feb 2004

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Sprout Pharmaceuticalsflibanserin
Sprout PharmaceuticalsFlibanserin
Sprout Pharmaceuticalsflibanserin 50 mg to 100 mg qhs
Sprout PharmaceuticalsFlibanserin
Sprout Pharmaceuticalsflibanserin
Sprout Pharmaceuticalsflibanserin flexible dose
Sprout Pharmaceuticals50 mg qhs
Sprout PharmaceuticalsFlibanserin
Sprout Pharmaceuticalsflibanserin
Sprout Pharmaceuticalsflibanserin
Sprout Pharmaceuticalsflibanserin
Sprout PharmaceuticalsFlibanserin
Pfizersildenafil
Sprout Pharmaceuticalsflibanserin 100 mg dose every evening

Clinical Trials (14)

Total enrollment: 11,531 patients across 14 trials

NCT01103362Sprout Pharmaceuticalsflibanserin

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Start: Apr 2010Est. completion: Jan 2011596 patients
Phase 3Terminated
NCT01057901Sprout PharmaceuticalsFlibanserin

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

Start: Jan 2010Est. completion: Jan 2011748 patients
Phase 3Terminated
NCT01040208Sprout Pharmaceuticalsflibanserin 50 mg to 100 mg qhs

12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

Start: Jan 2010Est. completion: Jan 2011111 patients
Phase 3Terminated
NCT00996164Sprout PharmaceuticalsFlibanserin

Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Start: Oct 2009Est. completion: Feb 20111,090 patients
Phase 3Completed
NCT00996372Sprout Pharmaceuticalsflibanserin

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Start: Oct 2009Est. completion: Mar 2011949 patients
Phase 3Completed
NCT00601367Sprout Pharmaceuticalsflibanserin flexible dose

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Start: Jan 2008Est. completion: Oct 2009480 patients
Phase 3Completed
NCT00491829Sprout Pharmaceuticals50 mg qhs

Flibanserin Versus Placebo in Premenopausal Women With HSDD

Start: Jun 2007Est. completion: Mar 2009945 patients
Phase 3Completed
NCT00441558Sprout PharmaceuticalsFlibanserin

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Start: Feb 2007Est. completion: Aug 20091,723 patients
Phase 3Terminated
NCT00360529Sprout Pharmaceuticalsflibanserin

24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

Start: Jul 2006Est. completion: Apr 2008880 patients
Phase 3Completed
NCT00360555Sprout Pharmaceuticalsflibanserin

Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Start: Jul 2006Est. completion: Mar 20081,584 patients
Phase 3Completed
NCT00360243Sprout Pharmaceuticalsflibanserin

6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

Start: Jul 2006Est. completion: Apr 20081,385 patients
Phase 3Completed
NCT00277914Sprout PharmaceuticalsFlibanserin

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Start: Jan 2006749 patients
Phase 3Completed
NCT00746967Pfizersildenafil

An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

Start: Jan 2003Est. completion: Feb 2004267 patients
Phase 2Completed
NCT01188603Sprout Pharmaceuticalsflibanserin 100 mg dose every evening

Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Start: Jul 2010Est. completion: Oct 201024 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

12 late-stage (Phase 3) programs, potential near-term approvals
2 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.