This section highlights FDA-related milestones and regulatory updates for drugs developed by United Therapeutics (UTHR).
Over the past two years, United Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ralinepag, Tyvaso, and UKidney. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ralinepag - FDA Regulatory Timeline and Events
ralinepag is a drug developed by United Therapeutics for the following indication: For the Treatment of Pulmonary Arterial Hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ralinepag
- Announced Date:
- June 23, 2025
- Indication:
- For the Treatment of Pulmonary Arterial Hypertension
Announcement
United Therapeutics Corporation announced the conclusion of enrollment of the phase 3 ADVANCE OUTCOMES study evaluating the use of an extended-release formulation of ralinepag for the treatment of pulmonary arterial hypertension (PAH).
AI Summary
United Therapeutics Corporation recently announced that enrollment for its phase 3 ADVANCE OUTCOMES study has been completed. This study is evaluating an extended‐release formulation of ralinepag for the treatment of pulmonary arterial hypertension (PAH). A total of 728 participants were enrolled, and they will continue to be monitored through the end of 2025 to track the time to the first clinical worsening event. Top-line results are expected in the first half of 2026.
If successful, ralinepag could be the first once-a-day oral prostacyclin agonist for PAH patients, offering a new treatment option that may change the current treatment approach. United Therapeutics expressed gratitude to the patients and clinical investigators who contributed to this important study.
Read Announcement
Tyvaso (Treprostinil) - FDA Regulatory Timeline and Events
Tyvaso (Treprostinil) is a drug developed by United Therapeutics for the following indication: Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tyvaso (Treprostinil)
- Announced Date:
- February 4, 2025
- Indication:
- Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Announcement
United Therapeutics Corporation announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).
AI Summary
United Therapeutics Corporation announced that enrollment for the TETON 1 study is now complete. This important Phase 3 trial is evaluating nebulized Tyvaso® (treprostinil) for treating idiopathic pulmonary fibrosis (IPF) in the United States and Canada. A total of 598 patients have been enrolled in this randomized, double-blind, placebo-controlled study, which will run over a 52-week period. The trial aims to assess the safety and effectiveness of nebulized Tyvaso in improving lung function and quality of life for IPF patients, a group with limited treatment options. Top-line data from TETON 1 are expected in the first half of 2026. If the data prove successful, United Therapeutics intends to use the study results to support an FDA filing to add IPF to the approved indications for nebulized Tyvaso, potentially offering a transformative treatment option.
Read Announcement- Drug:
- Tyvaso (Treprostinil)
- Announced Date:
- July 10, 2024
- Indication:
- Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Announcement
United Therapeutics Corporation announced full enrollment of the TETON 2 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).
AI Summary
United Therapeutics Corporation has reached full enrollment for its TETON 2 study, a Phase 3 trial testing nebulized Tyvaso® (treprostinil) for the treatment of idiopathic pulmonary fibrosis (IPF). The study, conducted at sites outside the United States and Canada, enrolled 597 patients. Over a 52‐week period, investigators will compare nebulized Tyvaso to a placebo to evaluate its safety and effectiveness. The TETON 2 trial is part of a broader global TETON program that aims to find better treatment options for a condition that affects over 100,000 people in the U.S. alone. Top-line results, which will focus on improvements in forced vital capacity (FVC) among other key measures, are expected in the second half of 2025.
Read Announcement- Drug:
- Tyvaso (Treprostinil)
- Announced Date:
- July 10, 2024
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Announcement
United Therapeutics Corporation announced that Top line data expected in the second half of 2025
AI Summary
United Therapeutics Corporation recently announced that the TETON 2 study has reached full enrollment and that top-line data is expected in the second half of 2025. This phase 3 trial evaluates the safety and efficacy of nebulized Tyvaso (treprostinil) in treating idiopathic pulmonary fibrosis (IPF) in patients located outside the United States and Canada. The study enrolled 597 patients as part of the global TETON clinical program, which is looking into how inhaled treprostinil may improve lung function and overall outcomes for patients with fibrotic lung diseases. United Therapeutics plans to use these findings to support potential FDA approval of Tyvaso for IPF, aiming to provide new treatment options for the more than 100,000 IPF patients in the United States.
Read Announcement
UKidney - FDA Regulatory Timeline and Events
UKidney is a drug developed by United Therapeutics for the following indication: Xenotransplantation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UKidney
- Announced Date:
- February 3, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- Xenotransplantation
Announcement
United Therapeutics Corporation announced that First xenotransplant is expected to occur around mid-year 2025
AI Summary
United Therapeutics Corporation has received clearance from the U.S. FDA to begin a first-in-human clinical trial using its investigational xenokidney, called UKidney™, derived from a genetically modified pig. This study targets patients with end-stage renal disease who have limited transplant options and may not be eligible for a conventional kidney transplant. The trial intends to enroll up to 50 participants, starting with an initial cohort of six individuals. A significant milestone in this initiative is that the first xenotransplant is expected to take place around mid-year 2025. The study will assess both the safety and efficacy of the UKidney transplant, with participants receiving post-transplant follow-up that includes regular monitoring of kidney function and checks for infections. United Therapeutics hopes that this innovative approach will provide a promising alternative to lifelong dialysis for many patients.
Read Announcement- Drug:
- UKidney
- Announced Date:
- February 3, 2025
- Indication:
- Xenotransplantation
Announcement
United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company's investigational UKidney™ derived from a 10 gene-edited source pig.
AI Summary
United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin a clinical study of its investigational UKidney™, an organ derived from a 10 gene-edited source pig. This study is designed to evaluate the safety and effectiveness of the UKidney in patients with end-stage renal disease (ESRD) who are not eligible for a conventional kidney transplant. Initially, six patients will receive the xenotransplant, with the potential to expand the trial to 50 participants. The aim is to gather data that will support a future Biologics License Application (BLA) submission to the FDA. The first xenotransplant under this trial is expected to be performed around mid-year 2025, offering a promising therapeutic alternative for patients reliant on dialysis.
Read Announcement
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