STENDRA (avanafil)
Stendra is a medication used for adult men who experience erectile dysfunction. It helps patients achieve an erection by improving blood flow to the penis during sexual activity. This drug is prescribed to address the physical aspects of the condition, though it requires sexual stimulation to be effective.
How STENDRA Works
Stendra works by inhibiting the enzyme PDE5, which is responsible for breaking down cGMP in the penis. By preventing this breakdown, it enhances the effects of nitric oxide released during sexual stimulation, leading to smooth muscle relaxation and increased blood flow.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-04-27
- Routes
- ORAL
- Dosage Forms
- TABLET
STENDRA Approval History
What STENDRA Treats
1 indicationsSTENDRA is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
STENDRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to STENDRA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02503306 CEDAR | AVANAL07163 U1111-1167-6889 | Ph 3 | completed | Efficacy and Tolerability Study of Avanafil in Russia |
| NCT01768676 results posted | TA-401 | Ph 4 | completed | Study Evaluating the Effects of Avanafil on Semen Parameters |
| NCT02477436 | Avanafil-Korea | Ph 2 | completed | Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction |
| NCT00895011 results posted | TA-303 | Ph 3 | completed | Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy |
| NCT00809471 REVIVE-D results posted | TA-302 | Ph 3 | completed | Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D) |
| NCT00853606 results posted | TA-314 | Ph 3 | completed | Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction |
| NCT00790751 REVIVE results posted | TA-301 | Ph 3 | completed | Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED |
| NCT01054261 | TA-013 | Ph 1 | completed | To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function. |
| NCT00769041 | TA-140 | Ph 1 | completed | A Thorough EKG Safety Study of TA-1790 (Avanafil) |
| NCT01095601 | TA-020 | Ph 1 | completed | Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects |
| NCT01054430 avanafil | TA-012 | Ph 1 | completed | To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects. |
| NCT01054859 | TA-015 | Ph 1 | completed | A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects. |
| NCT00903981 ALERT | CWP-AVA-301 | Ph 3 | completed | Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil |
| NCT00770042 | TA-011 | Ph 1 | completed | To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil |
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.
STENDRA FDA Label Details
Indications & Usage
FDA Label (PDF)STENDRA is indicated for the treatment of Erectile Dysfunction.
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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