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Epoprostenol

Phase 3FDA approved

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

Epoprostenol development status

FDA approval on record Jun 27, 2008
Approval holderActelion
ApplicationNDA022260
Highest phase Phase 3
Registered trials 2 across 2 sponsors since Jul 2011

Label indication VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

Epoprostenol target and mechanism

Molecular targetPTGIR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Epoprostenol clinical trials

Epoprostenol · 1 trial · 1 indication

Phase 3 1
NCT01470144Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension
COMPLETED41 Analytics
PHASE3COMPLETED
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Pulmonary Arterial HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment-emergent Adverse Events
On average 2.72 years

Secondary Endpoints

Exposure Duration
On average 2.72 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTALSingle arm, open-label

Interventions

NameTypeDescription
EpoprostenolDRUGAdministered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit
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Eligibility Criteria

SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Signed informed consent prior to initiation of any study-mandated procedure 2. Patients who completed participation in study AC-066A301 3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301 Exclusion Criteria: 1....

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Frequently asked questions about Epoprostenol

What is Epoprostenol used for?

Epoprostenol is used for the treatment of pulmonary arterial hypertension, a condition characterized by high blood pressure in the arteries of the lungs. It is being developed by Johnson & Johnson for this cardiovascular indication. The drug is a small molecule and is currently in Phase 3 clinical development.

How does Epoprostenol work?

Epoprostenol works as an agonist of PTGIR, the prostacyclin receptor. By activating this receptor, it mimics the effects of natural prostacyclin, leading to vasodilation and inhibition of platelet aggregation. This mechanism helps lower pulmonary arterial pressure and is beneficial in pulmonary arterial hypertension.

Who is developing Epoprostenol?

Epoprostenol is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development of this small molecule for pulmonary arterial hypertension.

What phase is Epoprostenol in?

Epoprostenol is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug is not yet approved. It remains an investigational therapy for pulmonary arterial hypertension.

What clinical trials is Epoprostenol in?

Epoprostenol has been studied in a Phase 3 clinical trial, NCT01470144, titled "Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension." This trial enrolled 41 patients and has been completed. It was an uncontrolled study without randomization or double-blinding.