ILOPROST · BELOTECA
ILOPROST is FDA-approved to treat 1 condition (same as AURLUMYN).
Details
- Status
- Prescription
- First Approved
- 2004-12-29
- Routes
- INHALATION
- Dosage Forms
- SOLUTION
ILOPROST Approval History
What ILOPROST Treats
1 indicationsILOPROST is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Frostbite
Same approved indications as AURLUMYN (same active ingredient).
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07498309 PROSTASICKLE | 2020/0421/HP 2025-522005-38-00 | Ph 3 | not yet recruiting | Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease |
| NCT06319274 COMBAT-ARF | COMBAT-ARF | Ph 2 | recruiting | Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure |
| NCT03788837 I-MICRO | P170924J | Ph 3 | completed | ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO) |
| NCT05411107 | NCI-2022-04698 NCI-2022-04698, NCI21-08-01 | Ph 2 | withdrawn | Oral Iloprost for the Prevention of Lung Cancer In Former Smokers |
| NCT03903939 SHINE-TRAUMA | SHINE-TRAUMA 2019-000936-24 | Ph 2 | completed | Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure |
| NCT04420741 COMBAT-COVID | COMBAT-COVID-19 2020-001296-33 | Ph 2 | completed | Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure |
| NCT04123444 COMBAT-SHINE | COMBAT-SHINE 2019-001131-31 | Ph 2, Ph 3 | completed | Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure |
| NCT02237183 | NCI-2014-01891 NCI-2014-01891, N01-CN-2012-00035 | Ph 1 | completed | Iloprost in Preventing Lung Cancer in Former Smokers |
| NCT03111212 ThIlo | ThIlo | Ph 3 | completed | Iloprost in Acute Respiratory Distress Syndrome |
| NCT02685618 ENDO-RCA | 2014092629 | Ph 2 | completed | Endothelial Dysfunction in Resuscitated Cardiac Arrest |
| NCT01437878 results posted | AC-063B201 | Ph 2 | terminated | Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD) |
| NCT00709098 PROWESS 15 Ext results posted | AC-063A302 | Ph 3 | completed | Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension |
| NCT00724321 | 58205 | Ph 1 | withdrawn | Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude |
| NCT00981591 | SCIL-001-12806 | Ph 1, Ph 2 | withdrawn | Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients |
| NCT01274481 | 15123 | Ph 1 | completed | Iloprost Effects on Gas Exchange and Pulmonary Mechanics |
| NCT01082484 INFLUX-IT-VS | 2009-016301-42 | Ph 1, Ph 2 | completed | Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers |
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.
ILOPROST FDA Label Details
Indications & Usage
ILOPROST is FDA-approved to treat 1 condition — same approved indications as AURLUMYN.
Looking for the branded version?
AURLUMYN
Full clinical data, patents, trials, and competitive landscape for iloprost.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.