Flibanserin

Generic Name: Flibanserin

Brand Names: Addyi

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁F_₃N_₄O

CAS Number: 167933-07-5

Unique Ingredient Identifier: 37JK4STR6Z

Background: Flibanserin is the first drug to be approved for hypoactive sexual desire disorder (HSDD) in premenopausal women by the FDA in August 2015. It was originally developed as an antidepressant medication by Boehringer Ingelheim, but showed lack of efficacy in trials and was further developed as a hypoactive sexual disorder drug by Sprout Pharmaceuticals. Flibanserin's mechanism of action is attributed to its high affinity for 5-HTA1 and 5-HTA2 receptors, displaying agonist activity on 5-HTA1 and antagonist on 5-HTA2, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters.

Indication: 用于治疗绝经前女性非疾病原因的性功能障碍，如机能减退性欲障碍（HSDD）。

Associated Conditions: Hypoactive Sexual Desire Disorder (HSDD)

Associated Therapies: -

Clinical Trials

Hypoactive Sexual Desire Disorder in Males

Phase 2

Recruiting

Conditions: Low Libido

Interventions: Drug: Flibanserin
Drug: Placebo

First Posted Date: 2019-06-28

Last Posted Date: 2024-03-18

Lead Sponsor: Mohit Khera

Target Recruit Count: 60

Registration Number: NCT04002661

Locations: 🇺🇸
Baylor College of Medicine, Houston, Texas, United States

Effects of Flibanserin on the Pre- and Post-menopausal Female Brain

Not Applicable

Terminated

Conditions: Hypoactive Sexual Desire Disorder

Interventions: Drug: Flibanserin
Drug: Placebo

First Posted Date: 2016-05-12

Last Posted Date: 2024-05-16

Lead Sponsor: University of Chicago

Target Recruit Count: 57

Registration Number: NCT02770768

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Phase 4

Terminated

Conditions: Hypoactive Sexual Desire Disorder

Interventions: Behavioral: sex therapy
Drug: flibanserin

First Posted Date: 2016-03-21

Last Posted Date: 2022-06-13

Lead Sponsor: San Diego Sexual Medicine

Target Recruit Count: 23

Registration Number: NCT02714049

Locations: 🇺🇸
San Diego Sexual Medicine, San Diego, California, United States

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

Phase 3

Terminated

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: flibanserin

First Posted Date: 2010-04-14

Last Posted Date: 2014-05-12

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 596

Registration Number: NCT01103362

Locations: 🇺🇸
511.133.01050 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States
🇺🇸
511.133.01059 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States
🇺🇸
511.133.01064 Boehringer Ingelheim Investigational Site, Newark, Delaware, United States

and more 92 locations

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

Phase 3

Terminated

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: Placebo
Drug: Flibanserin

First Posted Date: 2010-01-28

Last Posted Date: 2014-06-17

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 748

Registration Number: NCT01057901

Locations: 🇺🇸
511.156.01046 Boehringer Ingelheim Investigational Site, Plantation, Florida, United States
🇺🇸
511.156.01040 Boehringer Ingelheim Investigational Site, Statesville, North Carolina, United States
🇺🇸
511.156.01072 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States

and more 97 locations

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

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: flibanserin
Drug: placebo

First Posted Date: 2009-10-16

Last Posted Date: 2014-06-12

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 949

Registration Number: NCT00996372

Locations: 🇺🇸
511.130.01041 Boehringer Ingelheim Investigational Site, New Britain, Connecticut, United States
🇺🇸
511.130.01009 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
🇺🇸
511.130.01013 Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States

and more 72 locations

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

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: Placebo
Drug: Flibanserin

First Posted Date: 2009-10-16

Last Posted Date: 2014-05-19

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 1090

Registration Number: NCT00996164

Locations: 🇺🇸
511.147.01019 Boehringer Ingelheim Investigational Site, St. Petersburg, Florida, United States
🇺🇸
511.147.01023 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
🇺🇸
511.147.01055 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

and more 72 locations

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

Phase 3

Terminated

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: Flibanserin

First Posted Date: 2007-03-01

Last Posted Date: 2014-06-13

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 1723

Registration Number: NCT00441558

Locations: 🇨🇦
511.84.02015 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada
🇺🇸
511.84.01198 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
🇺🇸
511.84.01012 Boehringer Ingelheim Investigational Site, Seattle, Washington, United States

and more 193 locations

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

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: placebo
Drug: flibanserin

First Posted Date: 2006-08-04

Last Posted Date: 2016-06-27

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 1385

Registration Number: NCT00360243

Locations: 🇺🇸
511.70.01009 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States
🇺🇸
511.70.01022 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
🇺🇸
511.70.01057 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

and more 78 locations

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

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: flibanserin 50mg
Drug: placebo
Drug: flibanserin 100mg
Drug: flibanserin

First Posted Date: 2006-08-04

Last Posted Date: 2016-06-27

Lead Sponsor: Sprout Pharmaceuticals, Inc

Target Recruit Count: 1584

Registration Number: NCT00360555

Locations: 🇺🇸
511.75.01019 Boehringer Ingelheim Investigational Site, Seattle, Washington, United States
🇺🇸
511.75.01014 Boehringer Ingelheim Investigational Site, Encinitas, California, United States
🇺🇸
511.75.01017 Boehringer Ingelheim Investigational Site, Berkeley, California, United States

and more 74 locations

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