NDAINHALATIONSOLUTIONPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
VENTAVIS (iloprost) by Johnson & Johnson is 2 . First approved in 2004.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VENTAVIS (iloprost) is an inhaled prostacyclin analog approved in 2004 for pulmonary arterial hypertension. It functions as a vasodilator and platelet aggregation inhibitor, improving exercise capacity and hemodynamics in PAH patients. Delivered via inhalation solution, it offers a non-systemic route of administration.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); expect defensive positioning and resource reallocation toward LOE mitigation strategies.
Mechanism of Action
2 . Iloprost is a vasodilator and inhibits platelet aggregation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure
Started Oct 2019
279 enrolled
Septic Shock
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
Started Oct 2019
198 enrolled
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
Started Mar 2019
34 enrolled
Raynaud Phenomenon Secondary to Systemic Sclerosis
Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Started Feb 2018
31 enrolled
Hypertension, Pulmonary
Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
Started Sep 2016
64 enrolled
Hypertension, Pulmonary
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.