MedPath

Flibanserin

Generic Name
Flibanserin
Brand Names
Addyi
Drug Type
Small Molecule
Chemical Formula
C20H21F3N4O
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
-

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

Phase 3
Completed
Conditions
Sexual Dysfunctions, Psychological
Interventions
First Posted Date
2006-08-04
Last Posted Date
2016-06-27
Lead Sponsor
Sprout Pharmaceuticals, Inc
Target Recruit Count
880
Registration Number
NCT00360529
Locations
🇺🇸

511.71.01006 Boehringer Ingelheim Investigational Site, Plantation, Florida, United States

🇺🇸

511.71.01003 Boehringer Ingelheim Investigational Site, Danville, Pennsylvania, United States

🇺🇸

511.71.01031 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

and more 51 locations

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Phase 3
Completed
Conditions
Sexual Dysfunctions, Psychological
First Posted Date
2006-01-18
Last Posted Date
2012-03-16
Lead Sponsor
Sprout Pharmaceuticals, Inc
Target Recruit Count
749
Registration Number
NCT00277914
Locations
🇺🇸

511.74.01042 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States

🇺🇸

511.74.01041 Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States

🇺🇸

511.74.01013 Boehringer Ingelheim Investigational Site, San Diego, California, United States

and more 62 locations
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