Recent Updates
Recently added Catalysts

iloprost

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Johnson & Johnson|Last Updated: Feb 4, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

iloprost · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT00709098Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension
COMPLETED49 Analytics
NCT00709956Iloprost Power 15 in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension
COMPLETED64 Analytics
PHASE3COMPLETED
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Pulmonary Arterial HypertensionUnlock trial analytics
PHASE3COMPLETED
Iloprost Power 15 in Pulmonary Arterial Hypertension
Pulmonary Arterial HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment-emergent Adverse Events
Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.

Number of adverse events

Treatment-emergent Serious Adverse Events
Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.

Number of serious adverse events

Adverse Events Leading to Premature Discontinuation of Study Drug
Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.

Number of adverse events leading to discontinuation of study treatment

Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.

Number of patients with adverse events leading to discontinuation of study treatment

6-minute-walk Distance (6MWD)
Study day 2 or study day 3

The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk. It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.

Safety

Secondary Endpoints

Borg Dyspnea Score
Study day 2 or study day 3
6 minute walk distance
exercise associated oxygen desaturation
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
iloprost power 6ACTIVE_COMPARATORiloprost power 15
iloprost power 15EXPERIMENTALiloprost power 15
Active / placeboEXPERIMENTALSingle dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3
Placebo / activePLACEBO_COMPARATORSingle dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3

Interventions

NameTypeDescription
iloprostDRUGIloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
iloprost (5 µg)DRUGSingle dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
placeboDRUGSingle dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Iloprost Inhalation Solution (Ventavis)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: 1. Signed informed consent prior to initiation of any study mandated procedure, 2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301, 3. Women of childbearing potential must have...

Countries:United StatesAustriaGermany
Unlock Eligibility Criteria

Frequently asked questions about iloprost

What is Iloprost used for?

Iloprost is a small molecule being studied for pulmonary fibrosis and pulmonary arterial hypertension. It is an investigational drug in clinical development, and it is not approved for these uses. Clinical trials have evaluated inhaled iloprost in adults with abnormal pulmonary pressure associated with idiopathic pulmonary fibrosis.

How does Iloprost work?

Iloprost is a prostacyclin analog that works by relaxing blood vessels and reducing pressure in the pulmonary arteries. It is being studied for conditions involving abnormal pulmonary pressure, such as pulmonary fibrosis and pulmonary arterial hypertension.

Who makes Iloprost?

Iloprost is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for pulmonary fibrosis and pulmonary arterial hypertension.

What phase is Iloprost in?

Iloprost is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials have been completed for its use in pulmonary fibrosis and pulmonary arterial hypertension.

What clinical trials is Iloprost in?

Iloprost has been studied in clinical trials including NCT00109681, which evaluated inhaled iloprost in adults with abnormal pulmonary pressure associated with idiopathic pulmonary fibrosis, and NCT00709098 and NCT00709956, which studied Iloprost Power 15 in pulmonary arterial hypertension. These trials have been completed.

Is Iloprost the same as Iloprost Power 15?

Iloprost Power 15 is a formulation of Iloprost that has been studied in clinical trials for pulmonary arterial hypertension. The trials NCT00709098 and NCT00709956 evaluated this specific formulation in patients with the condition.