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The FDA is expected to decide on Tyvaso for Idiopathic pulmonary fibrosis in late April 2027, under a sNDA from United Therapeutics.
What the FDA is deciding on Tyvaso for Idiopathic pulmonary fibrosis
The FDA is reviewing United Therapeutics' request to approve Tyvaso (nebulized treprostinil) for a new use, idiopathic pulmonary fibrosis.
United Therapeutics says that, if approved, it would be the first inhaled antifibrotic for IPF. United Therapeutics reported that in a combined analysis of its TETON-1 and TETON-2 trials, people on Tyvaso kept 111.8mL more lung capacity (forced vital capacity, FVC) than people on placebo at week 52.
United Therapeutics has disclosed only that it expects the review to finish in late April 2027.
Who the Tyvaso decision matters to
Idiopathic pulmonary fibrosis is a chronic, progressive lung disease characterized by scarring (fibrosis) of lung tissue. The fibrosis reduces lung capacity and oxygen transfer, causing progressive dyspnea and hypoxemia.
Three antifibrotic drugs are FDA approved to slow the loss of lung function: pirfenidone, nintedanib and nerandomilast (Jascayd), approved in October 2025.
Prevalence: About 100,000 people in the U.S., with 30,000 to 40,000 new cases a year (MedlinePlus Genetics). See our full Idiopathic Pulmonary Fibrosis page for current treatments, recruiting trials, and community resources.
How Tyvaso works
Tyvaso: prostacyclin analog that dilates pulmonary blood vessels and inhibits platelet aggregation. Our full Tyvaso profile covers how it works, side effects in plain language, and its trial history.
What an approval or a rejection of Tyvaso 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. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Idiopathic Pulmonary Fibrosis treatment stands today
Read our full Idiopathic Pulmonary Fibrosis treatment summary
Three antifibrotic medications are FDA approved for IPF: pirfenidone (Esbriet and generics), nintedanib (Ofev, with generics approved in April 2026) and nerandomilast (Jascayd, approved October 7, 2025), which was tested both on its own and alongside either of the other two. Each slows the loss of lung function rather than reversing scarring.
Several other approaches are in late-stage testing, including inhaled treprostinil (Tyvaso), which United Therapeutics has asked the FDA to approve for IPF with the review expected to finish in late April 2027, and admilparant from Bristol Myers Squibb, whose Phase 3 ALOFT-IPF trial met its main goal at the 60mg dose, the company announced on October 12, 2026.
Getting an accurate diagnosis through clinical evaluation, high-resolution CT imaging, and sometimes lung biopsy is an important first step, since it opens the door to both approved therapies and clinical trials. The Pulmonary Fibrosis Foundation can help you find studies near you, and for patients with advanced disease, lung transplantation remains a viable option worth discussing with your care team.
The Idiopathic Pulmonary Fibrosis page has every treatment and trial →Meanwhile, 105 Idiopathic Pulmonary Fibrosis studies are open or about to open
Whatever the FDA decides here, research on Idiopathic Pulmonary Fibrosis does not stop. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Idiopathic Pulmonary Fibrosis. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Frequently asked questions
When will the FDA decide on Tyvaso?
United Therapeutics expects a decision in late April 2027 but has not given an exact date.
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 Tyvaso being reviewed for?
United Therapeutics submitted a sNDA for Tyvaso in Idiopathic pulmonary fibrosis.
What to know: United Therapeutics says that, if approved, it would be the first inhaled antifibrotic for IPF. United Therapeutics reported that in a combined analysis of its TETON-1 and TETON-2 trials, people on Tyvaso kept 111.8mL more lung capacity (forced vital capacity, FVC) than people on placebo at week 52. United Therapeutics has disclosed only that it expects the review to finish in late April 2027.
How it works: Prostacyclin analog that dilates pulmonary blood vessels and inhibits platelet aggregation.
More: the Tyvaso drug page explains it in plain language.
Is there already an FDA-approved treatment for Idiopathic Pulmonary Fibrosis?
Yes. Trial Friend's drug list includes 3 FDA-approved drugs for Idiopathic Pulmonary Fibrosis.
Approved: Ofev (nintedanib), Esbriet (pirfenidone), Jascayd (nerandomilast).
Also coming: Admilparant.
Check: the Idiopathic Pulmonary Fibrosis page also searches FDA drug labels for approved treatments.
What are the side effects of Tyvaso?
Route-dependent: IV/SC can cause infusion site pain, headache, diarrhea, and jaw pain. Inhaled versions cause cough and throat irritation.
More: the Tyvaso drug page has the label's warnings in full.
Can I get Tyvaso before the FDA decides?
Tyvaso is already FDA approved for other conditions, but not yet for Idiopathic pulmonary fibrosis, and insurers may not cover use for an unapproved condition.
Trials: 105 Idiopathic Pulmonary Fibrosis studies are open or about to open. 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 Tyvaso cost?
Tyvaso is already sold in the US for other conditions. Trial Friend does not list a price, and coverage for Idiopathic pulmonary fibrosis depends on the FDA decision and your insurer.
Drugmaker help: United Therapeutics Cares.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Tyvaso 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.