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Ralinepag

Phase 3

PAH | Small molecule | Immunology |United Therapeutics Corporation|Last Updated: Jun 16, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,687
FDA Designations
No designations recorded
Clinical trial landscape

Ralinepag · 3 trials · 11 indications

Phase 3 2Phase 2 1
NCT03683186A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionPAH
ENROLLING BY_INVITATION1,000 Analytics
NCT03626688A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsPAH
COMPLETED687 Analytics
PHASE3ENROLLING BY_INVITATION
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
PAH
NCT036831861,000
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PHASE3COMPLETED
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
PAH
NCT03626688687
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Study Endpoints
Primary Endpoints
Number of subjects with treatment-emergent adverse events [Safety and Tolerability]
Up to 6 years

The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events

Time from randomization to the first adjudicated protocol-defined clinical worsening event
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years

Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).

Change From Baseline in Pulmonary Vascular Resistance
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

Pulmonary vascular resistance was collected by right heart catheterization (RHC).

Change From Baseline in Cardiac Output
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

Cardiac output was collected by right heart catheterization (RHC).

Change From Baseline in Cardiac Index
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

Cardiac index was collected by right heart catheterization (RHC).

Change From Baseline in Mean Pulmonary Arterial Pressure
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).

Secondary Endpoints
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Baseline to Week 28
Change from Baseline in 6-minute walk distance (6MWD)
Baseline to Week 28
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
Baseline to Week 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RalinepagEXPERIMENTALRalinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
PlaceboPLACEBO_COMPARATORMatching placebo tablets (oral)
Oral RalinepagEXPERIMENTALRalinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration.
Interventions
NameTypeDescription
RalinepagDRUGActive
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites190

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treat...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaDenmarkFranceGermanyGreeceHungaryIsraelItalyMexicoNetherlandsPolandPortugalRomaniaSerbiaSingaporeSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)UkraineUnited KingdomSlovakia
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Recent Changes (Last 90 Days)
MEDIUMJul 17, 2026NCT03626688TRIAL_REMOVED: changed
MEDIUMJul 17, 2026NCT03626688TRIAL_REMOVED: changed
MEDIUMJul 17, 2026NCT03626688TRIAL_REMOVED: changed
LOWMay 26, 2026NCT03683186primaryCompletionDate: changed
LOWMay 24, 2026NCT03683186studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT03626688TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT03626688TRIAL_REMOVED: changed