Addyi

(flibanserin)

Phase 2Small molecule

SSprout Pharmaceuticals, Inc

Addyi is one of 24 small molecule programs targeting Prostate Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Prostate CancerActive, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Mekinist

Novartis

Preclinical

3 2

Addyi

SSprout Pharmaceuticals, Inc

Phase 2

1 3

Trexall

Alnylam Pharmaceuticals

Preclinical

—4

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 5

Viagra

VViatris Specialty LLC

Preclinical

1 6

Duragesic

CCephalon

Preclinical

1 7

Prednisone/prednisolone

Roche

Preclinical

3 8

Triptorelin Pamoate

Ipsen

Preclinical

2 9

Ifex

BBaxter Healthcare Corporation

Xylocaine

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Menopausal Women5 trials

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

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

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

Show 2 more trials

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

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

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

Postmenopausal Women4 trials

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

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

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

Show 1 more trial

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

Sex3 trials

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

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

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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

Hypoactive Sexual Desire Disorder in Males

Terminated·MMohit Khera·Phase 2·NCT04002661·8 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

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 Cancer1 trial

Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

Active, not recruiting·AAndrew McDonald·Phase 2·NCT04743934·44 enrolled

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

Regulatory

FDA Approval Timeline[4]

Aug 18, 2015

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]
Open Targets Platform — Drug–disease associations for flibanserin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022526). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Addyi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sprout Pharmaceuticals, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSprout Pharmaceuticals, Inc

Patent Landscape[5]

Patent Cliff

May 9, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7151103May 9, 2028

Addyi

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Menopausal Women5 trials

Postmenopausal Women4 trials

Sex3 trials

Female1 trial

Depressed1 trial

MACE1 trial

Prostate Cancer1 trial

Women1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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