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Study on the Long-term Safety and Efficacy of Ralinepag for Patients with Pulmonary Arterial Hypertension

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a medication called Ralinepag in patients with a condition known as pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The medication being tested, Ralinepag, is taken as a prolonged-release tablet, which means it is designed to release the drug slowly over time after being taken orally.

The purpose of this study is to evaluate the long-term safety and how well patients tolerate Ralinepag. Participants in this study have previously taken part in earlier phases of research involving Ralinepag. During the study, participants will continue to take the medication and attend regular visits to monitor their health and the effects of the treatment. The study will assess various health indicators, such as levels of a specific protein in the blood, the distance a patient can walk in six minutes, and overall quality of life. These assessments help researchers understand how the medication impacts the condition over an extended period.

This study is an open-label extension, meaning that all participants will receive Ralinepag, and there is no placebo group. The study aims to provide valuable information on the long-term use of Ralinepag for managing pulmonary arterial hypertension, contributing to a better understanding of its safety and effectiveness for patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must have completed the necessary procedures from a previous study involving ralinepag.

    The participant must have signed an informed consent form, indicating understanding of the study's details.

  2. Step 2

    Medication administration

    The participant will take ralinepag, which is a prolonged-release tablet, by mouth.

    The dosage and frequency of the medication will be determined by the study protocol and the participant's previous study involvement.

  3. Step 3

    Regular assessments

    Throughout the study, the participant will undergo regular assessments to evaluate the effectiveness and safety of ralinepag.

    These assessments include measuring NT-proBNP levels, a 6-minute walk distance test, and evaluating functional class according to WHO/NYHA standards.

  4. Step 4

    Monitoring and follow-up

    The participant will be monitored for any hospitalizations or changes in health status during the study period.

    A follow-up visit will occur 30 days after the last dose of ralinepag to ensure the participant's well-being.

  5. Step 5

    Study completion

    The study is estimated to conclude by December 29, 2025.

    Upon completion, the participant will have contributed to understanding the long-term safety and effectiveness of ralinepag for pulmonary arterial hypertension.

Who can join the trial?

6 criteria

  • The patient must have **pulmonary arterial hypertension (PAH)**, which is high blood pressure in the arteries of the lungs.
  • The patient must have signed and dated an **Informed Consent Form**, showing they understand the study details before any study-related activities begin.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and complete lab tests and other study procedures.
  • The patient must have completed the necessary visits in the previous study involving the study drug, **ralinepag**.
  • Both male and female patients must agree to use a highly effective method of **birth control** during the study and for 30 days after the last dose of the study drug, if there is a chance of pregnancy.
  • Patients must agree not to try to become pregnant or cause pregnancy, donate sperm, or participate in **in vitro fertilization** during the study and for 30 days after the last dose of the study drug.

Who cannot join the trial?

4 criteria

  • Patients who have not participated in a previous Phase 2 or Phase 3 study of the medication called ralinepag cannot join the study.
  • Patients with medical conditions other than pulmonary arterial hypertension (PAH) are not eligible. PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are considered part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent, may not be eligible.
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Investigated drugs

Ralinepag (APD811): This medication is being studied for its long-term safety and effectiveness in treating pulmonary arterial hypertension (PAH). It is designed to help improve blood flow in the lungs by relaxing and widening the blood vessels, which can reduce the workload on the heart and improve symptoms in patients with PAH. Participants in this trial have previously taken part in earlier studies of this medication.

What is already known about the treatment

Ralinepag – Ralinepag is administered orally in tablet form and is currently being studied for its long-term safety and effectiveness in treating pulmonary arterial hypertension (PAH). It is in the clinical trial phase, with ongoing research to assess its benefits and risks. The main therapeutic indication for ralinepag is PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, ralinepag works by targeting and activating specific receptors in the body that help relax blood vessels, thereby reducing blood pressure in the lungs. It is classified pharmacologically as a prostacyclin receptor agonist, which means it mimics the action of natural substances in the body that help dilate blood vessels.

Investigated diseases

Pulmonary Arterial Hypertension (PAH) – Pulmonary arterial hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may become enlarged and weakened due to the increased workload. The disease can progress gradually, with symptoms worsening as the pressure in the pulmonary arteries continues to rise. It is considered a rare disease and can affect individuals of any age, though it is more common in young adults. The progression of PAH can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a slower progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509305-68-00Protocol codeROR-PH-303Estimated enrolment575 patientsSponsorUnited Therapeutics Corp.

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