ADDYI (flibanserin)
ADDYI is indicated for the treatment of Hypoactive Sexual Desire Disorder.
How ADDYI Works
The mechanism of action of Addyi in the treatment of women with acquired, generalized hypoactive sexual desire disorder is not known. The provided clinical information does not identify a specific biological target or describe how the drug produces its therapeutic effect through activation or inhibition. Consequently, the biological pathways involved in how the drug addresses low sexual desire remain unestablished.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-08-18
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
ADDYI Approval History
What ADDYI Treats
1 indicationsADDYI is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoactive Sexual Desire Disorder
ADDYI Boxed Warning
HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Contraindicated with Strong or Moderate CYP3A4 Inhibito...
WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2) ] . Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4) ] . Contraindicated in Patients with Hepatic Impairment The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5) ] . Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4) ] . WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning. • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. ( 4 , 5.1 ) • Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated. ( 4 , 5.2 , 5.5 )
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04002661 HSDD | H-44634 | Ph 2 | terminated | Hypoactive Sexual Desire Disorder in Males |
| NCT02714049 | SDSM-2015-03 | Ph 4 | terminated | Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy |
| NCT01057901 results posted | 511.156 | Ph 3 | terminated | Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America |
| NCT00996372 results posted | 511.130 | Ph 3 | completed | Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women |
| NCT00996164 results posted | 511.147 | Ph 3 | completed | Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder |
| NCT01103362 results posted | 511.133 | Ph 3 | terminated | A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADDYI FDA Label Details
Indications & Usage
FDA Label (PDF)ADDYI is indicated for the treatment of Hypoactive Sexual Desire Disorder.
WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standar...
ADDYI Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ADDYI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment