EDEX (alprostadil)
Edex is a medication used for men experiencing erectile dysfunction. It helps patients with various underlying causes, including nerve-related, blood vessel-related, or psychological issues. This drug is prescribed to help achieve an erection by relaxing the smooth muscles and arteries in the penis.
How EDEX Works
This drug works by binding to specific receptors in penile tissue, which increases cAMP levels and reduces calcium in the muscle cells. This process relaxes the smooth muscles and dilates the cavernous arteries, allowing blood to fill the lacunar spaces. The resulting pressure traps the blood within the penis, creating an erection through the corporal veno-occlusive mechanism.
Details
- Status
- Prescription
- First Approved
- 1997-06-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EDEX Approval History
What EDEX Treats
1 indicationsEDEX is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
EDEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
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3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00610051 | 3-T02-07-0106 | Ph 3 | not yet recruiting | ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure |
| NCT02895373 ECMO_PGE1 | ECMO_PGE1_2.1 | Ph 2 | terminated | PGE1 as Additive Anticoagulant in ECMO-Therapy |
| NCT03296670 | LSG1501104 | Ph 4 | completed | Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP |
| NCT02228850 | NexMed 2014-RPS-001 | Ph 2 | completed | Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis |
| NCT01776320 | 103243 | Ph 4 | withdrawn | Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction |
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.
EDEX FDA Label Details
Indications & Usage
FDA Label (PDF)EDEX 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.