Flibanserin

Overview

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer	2021/02/08	NCT04743934	Phase 2	Active, not recruiting	Andrew McDonald
Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)	2020/07/31	NCT04494191	Phase 1	Completed	Genuine Research Center, Egypt
Hypoactive Sexual Desire Disorder in Males	2019/06/28	NCT04002661	Phase 2	Recruiting	Mohit Khera
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors	2018/10/16	NCT03707340	Phase 2	Active, not recruiting	Memorial Sloan Kettering Cancer Center
Effects of Flibanserin on the Pre- and Post-menopausal Female Brain	2016/05/12	NCT02770768	Not Applicable	Terminated	University of Chicago
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy	2016/03/21	NCT02714049	Phase 4	Terminated	San Diego Sexual Medicine
Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)	2010/08/25	NCT01188603	Phase 1	Completed	Sprout Pharmaceuticals, Inc
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers	2010/06/02	NCT01134965	Phase 1	Completed	Boehringer Ingelheim
A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder	2010/04/14	NCT01103362	Phase 3	Terminated	Sprout Pharmaceuticals, Inc
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America	2010/01/28	NCT01057901	Phase 3	Terminated	Sprout Pharmaceuticals, Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ADDYI	Sprout Pharmaceuticals, Inc.	58604-214	ORAL	100 mg in 1 1	10/1/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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