Tyvaso (treprostinil) / United Therapeutics Corporation - LARVOL DELTA

Breathing Easy: Cases of Transitioning Between Inhaled Prostacyclin Products (SCCM 2026) - "Once optimized, patients are often transitioned back to maintenance medications, however there is minimal to no evidence to guide the transition from nebulized epoprostenol to inhaled treprostinil products.Description: We present 3 patients with PH who were successfully transitioned from nebulized epoprostenol to inhaled treprostinil DPI (Tyvaso DPI®) or nebulizer (Tyvaso®) using multiple approaches. Pulmonologists specialized in PH and pharmacists are uniquely suited to develop treatment plans for transitioning patients between these high-risk medications. Further research and discussion regarding transitions between these inhaled agents would be beneficial to inform patient specific strategies in the future."

Clinical • Cardiovascular • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

United Therapeutics plans to submit a supplemental New Drug Application (sNDA) to the FDA by the second half of 2026 to add IPF to the labeled indications for nebulized Tyvaso following results from the ongoing TETON-1 study, which are expected soon (United Therapeutics Press Release)

FDA filing • P3 data • Idiopathic Pulmonary Fibrosis

United Therapeutics Corporation Announces Full Results of TETON-2 Phase 3 Clinical Trial Published in The New England Journal of Medicine (United Therapeutics Press Release) - "The study met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was −49.9 mL (95% confidence interval [CI], −79.2 to −19.5) in the nebulized Tyvaso group and −136.4 mL (95% CI, −172.5 to −104.0) in the placebo group, and the between group difference was 95.6 mL (95% CI, 52.2 to 139.0; P<0.001). Nebulized Tyvaso reduced risk of a clinical worsening event by 29% (hazard ratio, 0.71; 95% CI, 0.53 to 0.95; P=0.02) relative to placebo, a statistically significant improvement in this key secondary endpoint."

P3 data • Idiopathic Pulmonary Fibrosis

Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis. (PubMed, N Engl J Med) - P3 | "In patients with IPF, inhaled treprostinil was associated with a smaller decline in FVC and fewer clinical-worsening events than placebo over a period of 52 weeks. (Funded by United Therapeutics; TETON-2 ClinicalTrials.gov number, NCT05255991.)."

Journal • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The Minimal Important Difference in N-Terminal Pro-Brain Natriuretic Peptide in Pulmonary Hypertension. (PubMed, Chest) - "The estimated MID for short-term NT-proBNP improvement in PAH and PH-ILD is remarkably similar at 48%. Achievement of the MID for NT-proBNP change is strongly associated with clinically important outcomes in both PAH and PH-ILD, demonstrating that measuring NT-proBNP change over 12-16 weeks can be informative for prognosis and may be useful for decisions regarding treatment escalation in individuals with PAH and PH-ILD."

Journal • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • NPPB

TETON-PPF Clinical Trial of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis (ATS 2026) - No abstract available

Clinical • Immunology • Pulmonary Disease • Respiratory Diseases

TETON-1 Phase 3 Clinical Trial of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis (ATS 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

TETON Phase 3 Clinical Trials of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis: Integrated Efficacy and Safety Results for TETON-1 and TETON-2 (ATS 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

TETON: Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=598 | Completed | Sponsor: United Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

SAPPHIRE: Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=5 | Completed | Sponsor: University of Florida | Recruiting ➔ Completed | N=10 ➔ 5 | Trial completion date: Jul 2026 ➔ Dec 2025

Enrollment change • Trial completion • Trial completion date • Cardiovascular • Hypertension • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Sarcoidosis

A treprostinil inhaler (Yutrepia) for pulmonary hypertension. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Real-World Comparison of Patients With PH-ILD Initiating Inhaled Treprostinil Versus Patients Who Remain Untreated. (PubMed, Pulm Circ) - "Patients who initiated inhaled treprostinil had a 30% decreased risk of hospitalization compared to untreated patients (relative risk: 0.70; 95% CI: 0.59-0.83; p < 0.01). Among real-world patients with PH-ILD, treatment with inhaled treprostinil is associated with fewer all-cause hospitalizations and ICU-related hospitalizations compared to untreated patients with PH-ILD."

Journal • Real-world evidence • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

United Therapeutics Corporation Reports Record Third Quarter 2025 Financial Results (United Therapeutics Press Release) - "Total Tyvaso revenues grew by 10 percent to $478.0 million in the third quarter of 2025, compared to $433.8 million in the third quarter of 2024...Total Tyvaso revenues grew by 10 percent to $478.0 million in the third quarter of 2025, compared to $433.8 million in the third quarter of 2024...The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $11.7 million and, to a lesser extent, a price increase."

Commercial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Arterial Hypertension

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Bastiaan Driehuys | Phase classification: P1 ➔ P2

Phase classification • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Total Tyvaso product revenues grew 10% to $478 million, with Tyvaso DPI sales surging 22% to $336.2 million, partially offset by an 11% decline in nebulized Tyvaso (Investing.com)

Sales • Interstitial Lung Disease • Pulmonary Arterial Hypertension

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Bastiaan Driehuys | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2025 ➔ Sep 2025

Enrollment open • Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

MannKind Completes Acquisition of scPharmaceuticals, Accelerating Revenue Growth in Cardiometabolic Care (Mannkind Corp Press Release) - "The transaction will strengthen MannKind’s commercial and medical capabilities by integrating scPharmaceuticals’ experienced team into its existing infrastructure. MannKind is positioned as a diversified, growth-focused biopharmaceutical company with its commercial assets—Afrezza, FUROSCIX and V-Go -- along with Tyvaso DPI-related revenues, contributing to an annualized run rate of over $370 million based on Q2 2025 results. Additionally, the FUROSCIX ReadyFlow Autoinjector supplemental New Drug Application (sNDA) filing was submitted as planned in Q3 2025."

M&A • Pulmonary Arterial Hypertension • Type 2 Diabetes Mellitus

United Therapeutics Corporation Announces TETON-2 Pivotal Study of Tyvaso Meets Primary Endpoint for the Treatment of Idiopathic Pulmonary Fibrosis (Businesswire) - "Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use."

P3 data • Idiopathic Pulmonary Fibrosis

United Therapeutics Corporation to Review Data from the Successful TETON-2 Pivotal Study of Nebulized Tyvaso in Idiopathic Pulmonary Fibrosis - "During the webcast, Steven D. Nathan, M.D., Schar Chair, Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital and Chair of the TETON Steering Committee, will review data that were presented earlier in the day at the European Respiratory Society Congress."

Trial status • Idiopathic Pulmonary Fibrosis

TETON-OLE: Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (clinicaltrials.gov) - P3 | N=1850 | Enrolling by invitation | Sponsor: United Therapeutics | N=792 ➔ 1850

Enrollment change • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

BREEZE Optional Extension Phase: Long-Term Safety and Efficacy of Treprostinil Dry Powder Inhaler (Tyvaso DPI) in Pulmonary Arterial Hypertension. (PubMed, Respir Med) - P1 | "The BREEZE OEP successfully demonstrated the safety of long-term treatment with treprostinil DPI in patients with PAH."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

United Therapeutics Corporation Reports Record Second Quarter 2025 Financial Results (Businesswire) - "Tyvaso DPI record total revenue of $315 million, reflecting 22 percent growth over the second quarter of 2024....Double-digit, year-over-year revenue growth for Nebulized Tyvaso, Orenitram, and Unituxin with record quarterly revenue for Orenitram; Phase 3 TETON 2 study of Nebulized Tyvaso in idiopathic pulmonary fibrosis is complete; data expected in September 2025; phase 3 TETON 1 data expected in the first half of 2026; Enrollment for the phase 3 ADVANCE OUTCOMES study of ralinepag in pulmonary arterial hypertension is complete; data expected in the first half of 2026."

Enrollment closed • P3 data • Sales • Idiopathic Pulmonary Fibrosis • Neuroblastoma • Neuroendocrine Tumor • Pulmonary Arterial Hypertension

Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: University of California, San Diego

New P1 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TETON: Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=576 | Active, not recruiting | Sponsor: United Therapeutics | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

TETON-2: Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=597 | Completed | Sponsor: United Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Jan 2026 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases