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Epoprostenol

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01470144Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionPHASE3 COMPLETED 41Jun 1, 2011Jul 1, 2015Feb 4, 2025 -
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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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