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Prostacyclin Receptor Agonist

Ralinepag for Pulmonary Arterial Hypertension

Phase 3
Recruiting
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing ralinepag, a medication being developed for the treatment of pulmonary arterial hypertension (PAH). It aims to see if adding ralinepag to their usual treatments can improve their condition. The medication works by relaxing and opening up the blood vessels in the lungs, which can lower the pressure and improve blood flow.

Who is the study for?
Adults with symptomatic Pulmonary Arterial Hypertension (PAH) who can walk at least 150 meters unaided, are on stable PAH or other related medications for 30 days (10 days for diuretics), and have had a right heart catheterization within the last 3 years. Participants must not be pregnant, breastfeeding, have severe liver disease, recent malignancy except certain skin cancers, life expectancy less than a year, significant heart conduction issues or recent drug abuse.
What is being tested?
The trial is testing Ralinepag's effectiveness and safety in improving outcomes for PAH patients when added to their current treatment regimen. It compares Ralinepag against a placebo while all participants continue their standard care. The goal is to see if Ralinepag can better manage symptoms and progression of PAH.
What are the potential side effects?
Potential side effects of Ralinepag may include headache, diarrhea, nausea, flushing and jaw pain based on its mechanism as a prostacyclin receptor agonist which dilates blood vessels but could also cause systemic side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from randomization to the first adjudicated protocol-defined clinical worsening event
Secondary study objectives
Change from Baseline in 6-minute walk distance (6MWD)
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
+8 more

Side effects data

From 2021 Phase 2 trial • 45 Patients • NCT02279745
64%
Headache
38%
Diarrhoea
33%
Pain in jaw
31%
Nausea
27%
Myalgia
27%
Flushing
18%
Anaemia
18%
Dizziness
16%
Fatigue
16%
Arthralgia
16%
Pain in extremity
13%
N-terminal prohormone brain natriuretic peptide increased
13%
Right ventricular failure
13%
Hypotension
11%
Palpitations
11%
Upper respiratory tract infection
11%
Vomiting
11%
Iron deficiency
11%
Muscle spasms
9%
Cardiac failure
9%
Urinary tract infection
9%
Oedema peripheral
9%
Pneumonia
9%
Lower respiratory tract infection
9%
Dyspnoea exertional
9%
Dyspnoea
9%
Pruritus
7%
Hypokalaemia
7%
Respiratory tract infection
7%
Abdominal pain
7%
Non-cardiac chest pain
7%
Influenza
7%
Bronchitis
7%
Hyperkalaemia
7%
Back pain
7%
Syncope
7%
Presyncope
7%
Anxiety
7%
Pulmonary arterial hypertension
4%
Haematemesis
4%
Cardiac arrest
2%
Pneumonia aspiration
2%
Deep vein thrombosis
2%
COVID-19
2%
Oesophageal varices haemorrhage
2%
Abdominal distension
2%
COVID-19 pneumonia
2%
Atrial fibrillation
2%
Brain abscess
2%
Breast cancer in situ
2%
Varices oesophageal
2%
Benign breast neoplasm
2%
Pleural effusion
2%
Atrial flutter
2%
Pulmonary infarction
2%
Acute kidney injury
2%
Acute respiratory failure
2%
Arrhythmia supraventricular
2%
Asthenia
2%
Cardiac failure congestive
2%
Cardiopulmonary failure
2%
Chest pain
2%
Clostridium difficile infection
2%
Device related sepsis
2%
Drug withdrawal syndrome
2%
Epilepsy
2%
Foot fracture
2%
Gastroenteritis viral
2%
Haemoptysis
2%
Head injury
2%
Hyponatraemia
2%
Multiple organ dysfunction syndrome
2%
Myositis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Ralinepag

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RalinepagExperimental Treatment1 Intervention
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo tablets (oral)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ralinepag
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
110 Previous Clinical Trials
13,526 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
7,285 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Ralinepag (Prostacyclin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03626688 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: Placebo, Ralinepag
Pulmonary Arterial Hypertension Clinical Trial 2023: Ralinepag Highlights & Side Effects. Trial Name: NCT03626688 — Phase 3
Ralinepag (Prostacyclin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03626688 — Phase 3
~138 spots leftby Dec 2025
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