What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) similar to Ralinepag, such as other selective prostacyclin receptor agonists (e.g., selexipag), often have side effects including headache, nausea, vomiting, diarrhea, flushing, and jaw pain. Other treatments like oral endothelin receptor antagonists (ERAs) and phosphodiesterase type 5 inhibitors (PDE-5Is) can cause systemic vasodilatory effects such as hypotension and peripheral edema. Additionally, intravenous prostanoids like epoprostenol may lead to complications such as bloodstream infections due to the use of central venous catheters.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH) that are similar to Ralinepag, a Selective Prostacyclin Receptor Agonist. These include Epoprostenol, Treprostinil, and Iloprost, which are prostacyclin analogs that help to dilate blood vessels and inhibit platelet aggregation. Epoprostenol was the first prostacyclin approved for PAH, followed by Treprostinil, which is available in oral, inhaled, and subcutaneous forms, and Iloprost, which is administered via inhalation. These treatments aim to improve exercise capacity and symptoms in PAH patients.

What other types of research exist?

Promising novel alternatives to Ralinepag for PAH patients include: 1) Selexipag, an oral prostacyclin receptor agonist, which has shown efficacy in combination therapy. 2) Riociguat, a soluble guanylate cyclase stimulator, effective in improving exercise capacity and hemodynamics. 3) Macitentan, an endothelin receptor antagonist, known for improving long-term outcomes. These agents offer different mechanisms of action and can be considered based on individual patient profiles and treatment responses.

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Prostacyclin Receptor Agonist

Ralinepag for Pulmonary Arterial Hypertension

Phase 3

Waitlist Available

Research Sponsored by United Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag

Be older than 18 years old

Must not have

Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding

Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests ralinepag, a medication for lung disease, on patients with PAH who participated in earlier research. It aims to improve blood flow in the lungs by relaxing blood vessels and reducing pressure.

Who is the study for?

This trial is for individuals with WHO Group 1 Pulmonary Arterial Hypertension (PAH) who completed a prior ralinepag study. Participants must agree to use contraception if conception is possible and not attempt pregnancy during the study. Those who had drug-related issues or didn't complete previous ralinepag studies, are pregnant or breastfeeding, or had certain medical procedures are excluded.

What is being tested?

The trial tests the long-term effects of Ralinepag on PAH in an open-label extension format. This means everyone gets Ralinepag and knows what they're taking. It's for those who've already been part of earlier Phase 2 or Phase 3 trials involving this medication.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with PAH medications like Ralinepag may include headaches, diarrhea, nausea, rash, jaw pain, and flushing. Side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use birth control during the study and for 30 days after.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, trying to get pregnant, or breastfeeding.

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I have had a lung or heart/lung transplant or started long-term therapy with a prostacyclin since my last ralinepag study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Number of subjects with treatment-emergent adverse events [Safety and Tolerability]

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

Cardiac failure

Urinary tract infection

Oedema peripheral

Pneumonia

Lower respiratory tract infection

Dyspnoea exertional

Dyspnoea

Pruritus

Hypokalaemia

Respiratory tract infection

Abdominal pain

Non-cardiac chest pain

Influenza

Bronchitis

Hyperkalaemia

Back pain

Syncope

Presyncope

Anxiety

Pulmonary arterial hypertension

Haematemesis

Cardiac arrest

Pneumonia aspiration

Deep vein thrombosis

COVID-19

Oesophageal varices haemorrhage

Abdominal distension

COVID-19 pneumonia

Atrial fibrillation

Brain abscess

Breast cancer in situ

Varices oesophageal

Benign breast neoplasm

Pleural effusion

Atrial flutter

Pulmonary infarction

Acute kidney injury

Acute respiratory failure

Arrhythmia supraventricular

Asthenia

Cardiac failure congestive

Cardiopulmonary failure

Chest pain

Clostridium difficile infection

Device related sepsis

Drug withdrawal syndrome

Epilepsy

Foot fracture

Gastroenteritis viral

Haemoptysis

Head injury

Hyponatraemia

Multiple organ dysfunction syndrome

Myositis

100%

80%

60%

40%

20%

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RalinepagExperimental Treatment1 Intervention

Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ralinepag

2020

Completed Phase 2

~60

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pulmonary Arterial Hypertension (PAH) target three main pathways: the prostacyclin pathway, the endothelin pathway, and the nitric oxide pathway. Selective prostacyclin receptor agonists, such as Ralinepag, work by mimicking the effects of prostacyclin, a natural vasodilator that also inhibits platelet aggregation and smooth muscle cell proliferation. This helps to reduce pulmonary vascular resistance and improve blood flow in the lungs. Endothelin receptor antagonists block the effects of endothelin-1, a potent vasoconstrictor, thereby reducing blood pressure in the pulmonary arteries. Phosphodiesterase-5 inhibitors and soluble guanylate cyclase stimulators enhance the nitric oxide pathway, leading to vasodilation and improved oxygen delivery. These mechanisms are crucial for PAH patients as they directly address the underlying vascular abnormalities, improving symptoms, exercise capacity, and overall quality of life.