ALPROSTADIL
ALPROSTADIL is indicated for the treatment of Pulmonary Atresia; Pulmonary Stenosis; Tricuspid Atresia; Tetralogy of Fallot; Interruption of the Aortic Arch; Coarctation of the Aorta; Transposition of the Great Vessels; Congenital Heart Defects.
Details
- Status
- Prescription
- First Approved
- 1998-01-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ALPROSTADIL Approval History
What ALPROSTADIL Treats
8 indicationsALPROSTADIL is approved for 8 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Atresia
- Pulmonary Stenosis
- Tricuspid Atresia
- Tetralogy of Fallot
- Interruption of the Aortic Arch
- Coarctation of the Aorta
- Transposition of the Great Vessels
- Congenital Heart Defects
ALPROSTADIL Boxed Warning
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available....
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available.
ALPROSTADIL 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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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.
ALPROSTADIL FDA Label Details
Indications & Usage
ALPROSTADIL is indicated for the treatment of Pulmonary Atresia; Pulmonary Stenosis; Tricuspid Atresia; Tetralogy of Fallot; Interruption of the Aortic Arch; Coarctation of the Aorta; Transposition of the Great Vessels; Congenital Heart Defects.
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be moni...
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CAVERJECT IMPULSE
Full clinical data, patents, trials, and competitive landscape for alprostadil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.