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Iloprost

Phase 3FDA approved

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

Iloprost development status

FDA approval on record Dec 29, 2004
Approval holderActelion
ApplicationNDA021779
Highest phase Phase 3
Registered trials 5 across 4 sponsors since Jul 2008

Iloprost target and mechanism

Molecular targetPTGIR
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL494

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Iloprost clinical trials

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, PulmonaryUnlock 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
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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.)
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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
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Frequently asked questions about Iloprost

What is iloprost used for in pulmonary hypertension?

Iloprost is an inhaled small molecule developed for pulmonary hypertension, a condition of high blood pressure in the lung arteries. It is given by inhalation as Ventavis. Bayer AG is developing it, and the program has reached Phase 3 clinical development for this cardiovascular indication.

How does iloprost work?

Iloprost acts as an agonist at PTGIR, the prostacyclin receptor. By activating this receptor, it mimics the effects of natural prostacyclin, a signaling molecule involved in the pulmonary vasculature. This receptor agonist activity is the basis for its use in pulmonary hypertension.

Who makes iloprost?

Iloprost is developed by Bayer AG, which trades under the ticker BAYRY. The inhaled formulation is known as Ventavis. Bayer is the company behind the clinical development program for this small molecule in pulmonary hypertension.

What phase is iloprost in?

Iloprost is in Phase 3 clinical development for pulmonary hypertension. It is an investigational small molecule and has not been described as approved in this program. The Phase 3 study supporting this stage has been completed.

What clinical trials is iloprost in?

Iloprost has been studied in the Phase 3 trial NCT01469169, titled Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study. That trial enrolled 27 participants in Japan, included adults 18 years and older of all sexes, and has been completed.

Is iloprost the same as Ventavis?

Yes, Ventavis is the inhaled brand name for iloprost, and the compound is also referenced as BAYQ6256. Searches for Ventavis inhaled or BAYQ6256 refer to the same small molecule developed by Bayer AG for pulmonary hypertension.