Ralinepag for Pulmonary arterial hypertension
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The FDA is expected to decide on Ralinepag for Pulmonary arterial hypertension by June 24, 2027, under an NDA from United Therapeutics.
What is being decided
United Therapeutics has an NDA under FDA review for Ralinepag in Pulmonary arterial hypertension. Once-daily oral prostacyclin receptor agonist.
Who this decision matters to
Pulmonary arterial hypertension is a rare disease characterized by abnormally high blood pressure in the pulmonary arteries, causing progressive heart and lung damage. The disease involves vasoconstriction, thrombosis, and vascular remodeling. Multiple disease-modifying therapies targeting different pathways have improved survival and quality of life.
Prevalence: 1-2 per million people. See our full Pulmonary Arterial Hypertension page for current treatments, recruiting trials, and community resources.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where Pulmonary Arterial Hypertension treatment stands today
Read our full Pulmonary Arterial Hypertension treatment summary
The treatment approach for pulmonary arterial hypertension has shifted significantly toward early, aggressive combination therapy targeting multiple pathways at once, and current trials are building on that momentum. Sotatercept (Winrevair), an activin signaling inhibitor given as an injection under the skin every 3 weeks, was FDA approved in March 2024 for adults with PAH and works on a different pathway from the established endothelin, nitric oxide, and prostacyclin drugs.
Researchers are testing other new pulmonary vasodilators and antiproliferative agents that go beyond those pathways. Most guidelines now recommend starting combination therapy right at diagnosis rather than waiting, so if you have PAH, early action matters.
Regular monitoring through right heart catheterization helps your care team fine-tune your regimen over time. The Pulmonary Hypertension Association is an excellent resource for finding trials in your area, and if you have idiopathic or familial PAH, genetic testing can provide valuable information about your prognosis and potential trial eligibility.
The Pulmonary Arterial Hypertension page has every treatment and trial →Meanwhile, 129 Pulmonary Arterial Hypertension trials are recruiting
Whatever the FDA decides here, research on Pulmonary Arterial Hypertension does not stop. A few currently enrolling studies, US sites first:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Pulmonary Arterial Hypertension. Unsubscribe anytime.
Frequently asked questions
When will the FDA decide on Ralinepag?
The FDA's target date (PDUFA date) for Ralinepag in Pulmonary arterial hypertension is June 24, 2027.
Who disclosed it: United Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Ralinepag being reviewed for?
United Therapeutics submitted an NDA for Ralinepag in Pulmonary arterial hypertension.
What to know: Once-daily oral prostacyclin receptor agonist.
Is there already an FDA-approved treatment for Pulmonary Arterial Hypertension?
Yes. Trial Friend's drug list includes 12 FDA-approved drugs for Pulmonary Arterial Hypertension.
Approved: Flolan (epoprostenol), Tracleer (bosentan), Tyvaso (treprostinil), Ventavis (iloprost), Revatio (sildenafil), Letairis (ambrisentan), Adcirca (tadalafil), Adempas (riociguat), Opsumit (macitentan), Uptravi (selexipag), Winrevair (sotatercept), Yutrepia (treprostinil inhalation powder).
Check: the Pulmonary Arterial Hypertension page also searches FDA drug labels for approved treatments.
Can I get Ralinepag before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 129 Pulmonary Arterial Hypertension trials are recruiting now. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask United Therapeutics directly. Registered programs are listed on ClinicalTrials.gov.
How much will Ralinepag cost?
United Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Ralinepag decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from United Therapeutics press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.