Addyi

(flibanserin)

Small molecule

SSprout Pharmaceuticals, Inc

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Menopausal Women5 trials

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

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00996164·1,090 enrolled

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

Terminated·SSprout Pharmaceuticals, Inc·Phase 3·NCT00441558·1,723 enrolled

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

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00360555·1,584 enrolled

Show 2 more trials

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

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00360529·880 enrolled

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00277914·749 enrolled

Postmenopausal Women4 trials

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

Completed·SSprout Pharmaceuticals, Inc·Phase 1·NCT01188603·24 enrolled

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

Terminated·SSprout Pharmaceuticals, Inc·Phase 3·NCT01057901·748 enrolled

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

Terminated·SSprout Pharmaceuticals, Inc·Phase 3·NCT01103362·596 enrolled

Show 1 more trial

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

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00996372·949 enrolled

Sex3 trials

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00601367·480 enrolled

Hypoactive Sexual Desire Disorder in Males

Terminated·MMohit Khera·Phase 2·NCT04002661·8 enrolled

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Terminated·SSan Diego Sexual Medicine·Phase 4·NCT02714049·23 enrolled

Female1 trial

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

Terminated·UUniversity of Chicago·N/A·NCT02770768·57 enrolled

Depressed1 trial

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

Terminated·SSprout Pharmaceuticals, Inc·Phase 3·NCT01040208·111 enrolled

3 more indications

Women1 trial

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

Completed·SSprout Pharmaceuticals, Inc·Phase 3·NCT00360243·1,385 enrolled

MACE1 trial

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)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT04494191·26 enrolled

Prostate Adenocarcinoma1 trial

RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

Completed·AAndrew McDonald·Phase 2·NCT04743934·44 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 18, 2015

ADDYI

NDA NDA022526

Aug 18, 2015

ADDYI

NDA NDA022526

Apr 8, 2016

ADDYI

NDA NDA022526

Jun 16, 2017

ADDYI

NDA NDA022526

Apr 2, 2019

ADDYI

NDA NDA022526

Apr 11, 2019

ADDYI

NDA NDA022526

Oct 9, 2019

ADDYI

NDA NDA022526

Oct 9, 2019

ADDYI

NDA NDA022526

Sep 29, 2021

ADDYI

NDA NDA022526

Jan 21, 2025

ADDYI

NDA NDA022526

Dec 13, 2025

ADDYI

NDA NDA022526

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for flibanserin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — flibanserin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA022526). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Addyi. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sprout Pharmaceuticals, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SSprout Pharmaceuticals, Inc

Patent Landscape[4]

Patent Cliff

May 9, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7151103May 9, 2028

Addyi

Trials by Indication[1]

Menopausal Women5 trials

Postmenopausal Women4 trials

Sex3 trials

Female1 trial

Depressed1 trial

Women1 trial

MACE1 trial

Prostate Adenocarcinoma1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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