Recent Updates
Recently added Catalysts

Iloprost

Phase 3

Hypertension, Pulmonary | Small molecule | Cardiovascular |Bayer AG|Last Updated: Dec 7, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Iloprost · 1 trial · 1 indication

Phase 3 1
NCT01469169Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation StudyHypertension, Pulmonary
COMPLETED27 Analytics
PHASE3COMPLETED
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
Hypertension, Pulmonary
NCT0146916927
Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)
At baseline and 12 weeks
Number of participants with adverse events as a measure of safety and tolerability
Up to 52 weeks
Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC)
At baseline, 12 weeks, 52 weeks and over 52 weeks
Maximum drug concentration in plasma after start of inhalation (Cmax)
Up to 12 weeks

Secondary Endpoints

Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12
At baseline and 12 weeks
Change of mean of pulmonary artery pressure from baseline to week 12
At baseline and 12 weeks
Change of systolic pulmonary artery pressure from baseline to week 12
At baseline and 12 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Iloprost (Ventavis inhaled, BAYQ6256)DRUG2.5 μg or 5.0 μg BAYQ6256 per inhalation session (Inhalation session is to be conducted 6 to 9 times per day with dosing intervals of at least 2 hours.)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Male or female subjects aged 18 to 75 years * Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification 1) * New York Heart Association (NYHA)/World Health Organization (WHO) functional class III or IV * PAPmean at rest \> 25 mm Hg, Pulmonary capill...

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about Iloprost

What is Iloprost used for?

Iloprost is a small molecule cardiovascular drug being developed by Bayer AG for the treatment of pulmonary hypertension, a condition of high blood pressure in the arteries of the lungs. It is administered via inhalation and is currently in Phase 3 clinical development.

What does Iloprost target?

Iloprost is a synthetic prostacyclin analog that works by mimicking the effects of prostacyclin, a naturally occurring substance that dilates blood vessels and inhibits platelet aggregation. This helps to reduce pulmonary blood pressure and improve blood flow in patients with pulmonary hypertension.

Who makes Iloprost?

Iloprost is being developed by Bayer AG, a German multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.

What phase is Iloprost in?

Iloprost is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 study has been completed to evaluate its efficacy, safety, and pharmacokinetics in patients with pulmonary hypertension.

What clinical trials is Iloprost in?

Iloprost has one completed Phase 3 clinical trial, identified by the NCT number NCT01469169. This study, titled 'Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study,' enrolled 27 participants in Japan and was an uncontrolled, non-randomized, open-label trial.

Is Iloprost the same as Ventavis?

Yes, Iloprost is also known as Ventavis, which is the brand name for the inhaled formulation of the drug. The clinical trial NCT01469169 specifically refers to 'Inhaled Iloprost (Ventavis),' confirming that these names refer to the same medication.