Tyvaso (treprostinil) / United Therapeutics Corp - LARVOL DELTA

Safety of Low-Dose Oral Treprostinil in PH-HFpEF Supports Use in Patients with PAH with Cardiovascular Comorbidities (ISHLT 2025) - P3 | "Recent analyses of the FREEDOM-EV and TRIUMPH trials demonstrated no difference in treatment response or tolerability of oral and inhaled treprostinil (TRE) with increasing CV comorbidity burden...No oral TRE patients died during the study; one (2%) PBO patient died during the study.Conclusion In SOUTHPAW, AEs were consistent with prior TRE studies, and there were no concerning safety signals with low doses of oral TRE (study maximum dose 4 mg TID). This suggests that oral TRE may be safely used in PAH patients with CV comorbidities and risk factors for HFpEF."

Clinical • Cardiovascular • Congestive Heart Failure • Fatigue • Heart Failure • Pain • Pulmonary Disease

Heart Lung Transplantation for Fibrosing Mediastinitis (ISHLT 2025) - "While awaiting transplant, he was on dobutamine, tyvaso, diuretics & HFNC...Rituximab, Vascular & bronchoscopic stents and surgical corrections are options. Glucocorticoids & antifungals are not beneficial. Heart lung transplantation was successful in our case and may be considered."

Cardiovascular • Cough • Fibrosis • Pulmonary Arterial Hypertension • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Transplantation

Derivation of a simple risk calculator for predicting clinical worsening in patients with pulmonary hypertension due to interstitial lung disease. (PubMed, JHLT Open) - "The INCREASE study was a 16-week study that evaluated inhaled treprostinil in patients with ILD-PH...The risk calculators may also find utility as part of the composite allocation score of ILD-PH patients listed for lung transplant. Future research in this area could include incorporating longer-term outcomes as well as validating the risk models in a separate patient population."

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

Impact of Pharmacist Managed Pulmonary Arterial Hypertension Program on TYVASO Adherence (ISPOR 2025) - "OBJECTIVES: Pulmonary Arterial Hypertension (PAH) is a chronic condition requiring consistent medication adherence to optimize outcomes. Enrollment in the PAH program was associated with improved treprostinil adherence. These preliminary results highlight the potential of targeted pharmacy programs to enhance medication adherence and patient outcomes in PAH."

Adherence • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Teton Phase 3 Clinical Trials of Inhaled Treprostinil in the Treatment of Idiopathic Pulmonary Fibrosis: Annual Update of Preliminary Baseline Data (ATS 2025) - No abstract available

Clinical • P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

TETON-PPF Clinical Trial of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis: Preliminary Baseline Demographics (ATS 2025) - No abstract available

Clinical • Immunology • Pulmonary Disease • Respiratory Diseases

Tyvaso, a treatment for pulmonary hypertension, re-challenges for listing as an 'essential treatment drug' [Google translation] (HIT News) - "'Tyvaso Inhalation Solution (ingredient: treprostinil),' a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD), has reapplied for reimbursement as an essential drug for medical treatment. As the scope of use has been adjusted for reapplication, attention is being paid to whether it will be listed on the essential drug track, which has effectively become a dead letter....In order to be included in the essential medicine track, all of the following conditions must be met: there must be no alternative treatment, life-threatening serious disease, rare disease, etc., targeting a small number of patients, and demonstrating clinically meaningful improvement. Therefore, the essential medicine status has become meaningless since 2015."

Reimbursement • Interstitial Lung Disease • Pulmonary Arterial Hypertension

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 | Recruiting ➔ Active, not recruiting

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

United Therapeutics Corporation Reports Fourth Quarter and Full Year 2024 Financial Results (Businesswire) - "'both TETON studies in idiopathic pulmonary fibrosis are enrolled, facilitating data starting the second half of this year; ralinepag, our potentially best-in-class once-daily oral prostacyclin agonist, will generate data next year'...Total Tyvaso revenues grew by 19 percent to $415.9 million in the fourth quarter of 2024, compared to $350.6 million in the fourth quarter of 2023...Total Tyvaso revenues grew by 31 percent to $1,620.4 million in 2024, compared to $1,233.7 million in 2023...The growth in Remodulin revenues resulted from an increase in U.S. Remodulin revenues, driven by an increase in quantities sold. The growth in Orenitram revenues resulted from an increase in quantities sold and, to a lesser extent, a price increase."

Clinical data • Commercial • P3 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Respiratory Diseases

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=29 | Completed | Sponsor: Mayo Clinic | Enrolling by invitation ➔ Completed

Trial completion • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

United Therapeutics Corporation Announces Full Enrollment of the TETON 1 Study of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis (Businesswire) - "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). The TETON 1 study enrolled 598 patients and is part of the three-study global TETON clinical trial program evaluating the use of inhaled treprostinil in IPF and a similar condition, progressive pulmonary fibrosis (PPF)....Enrollment in TETON 2 completed in July 2024 and top-line data for that study is expected in the second half of 2025....The TETON 1 study is a 598-patient, multicenter, randomized, double-blind, placebo-controlled phase 3 registration study to evaluate the safety and efficacy of nebulized Tyvaso in subjects with IPF over a 52-week period at sites in the United States and Canada. The study reached full enrollment in January 2025 and top-line data is expected in the first half of 2026."

Enrollment closed • P3 data: top line • Idiopathic Pulmonary Fibrosis

United Therapeutics Corporation to Feature Clinical Data Across its Commercial and Development Portfolio at the Pulmonary Vascular Research Institute 2025 Annual Congress (Businesswire) - "United Therapeutics Corporation...announced that five posters across its commercial and development portfolio in pulmonary hypertension (PH) will be presented at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress taking place January 29 through February 1, 2025 in Rio de Janeiro. In addition, professionals from United Therapeutics will participate in two speaking events associated with the congress."

Clinical data • Pulmonary Arterial Hypertension

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=24 | Enrolling by invitation | Sponsor: Mayo Clinic | Trial completion date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Treatment with Oral or Inhaled Treprostinil in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities. (PubMed, Chest) - "This post hoc analysis suggests that patients with PAH and cardiovascular comorbidities can benefit from combination therapy with inhaled or oral treprostinil."

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

Patents delisted for Tyvaso from Orange Book (Orange Book) - Patent no.s 10716793 and 9604901

Patent • Idiopathic Pulmonary Fibrosis

United Therapeutics Corporation Reports Third Quarter 2024 Financial Results (Businesswire) - "Total Tyvaso revenues grew by 33 percent to $433.8 million in the third quarter of 2024, compared to $325.8 million in the third quarter of 2023. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in commercial utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, price increases."

Commercial • Idiopathic Pulmonary Fibrosis

Tyvaso: Newly added patent in Orange Book (Orange Book) - Expiry on May 14, 2027 and Dec 15, 2028

Patent • Idiopathic Pulmonary Fibrosis

7250: TYVASO DPI® (treprostinil inhalation powder): Clinical Pearls and Drug-Device Characteristics (CHEST 2024) - "Description: This event brings together renowned experts and experienced clinicians at the forefront of PAH and PH-ILD care and research. We aim to review clinical evidence related to inhaled prostacyclin therapy and discuss patient selection, side effect management, transitions between different formulations, and drug-device technical characteristics."

Clinical

LONG-TERM OUTCOMES AND DOSING IN THE BREEZE STUDY OPTIONAL EXTENSION PHASE (CHEST 2024) - P1 | "In patients with PAH, Tyvaso DPI was safe and well-tolerated. The persistent benefit on 6MWD may be attributed to the up-titrated dose over time, which has been seen in other studies of inhaled treprostinil, or alternatively may be associated with improved compliance. CLINICAL IMPLICATIONS: Tyvaso DPI is a safe and tolerable treatment option for patients with PAH that may provide long-term maintenance of clinical stability."

Cough • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

COPD associated pulmonary hypertension: A post hoc analysis of the PERFECT study. (PubMed, Pulm Circ) - "The PERFECT study, a randomized, controlled, double-blind study of inhaled treprostinil in patients with COPD and associated pulmonary hypertension (PH-COPD) was a negative trial that was terminated early...These analyses are post hoc, observational, and exploratory. The thresholds defining the spectrum of responders are preliminary and may require further refinement and validation in future studies."

Journal • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • NPPB

TETON-OLE: Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=792 | Enrolling by invitation | Sponsor: United Therapeutics | Trial primary completion date: Jun 2024 ➔ Jun 2026

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

United Therapeutics Corporation Reports Second Quarter 2024 Financial Results (United Therapeutics Press Release) - "United Therapeutics Corporation...announced its financial results for the quarter ended June 30, 2024. Total revenues in the second quarter of 2024 grew 20 percent year-over-year to $714.9 million, compared to $596.5 million in the second quarter of 2023...Total Tyvaso revenues grew by 25 percent to $398.2 million in the second quarter of 2024, compared to $318.9 million in the second quarter of 2023. This growth was primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in commercial utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, price increases....Cost of sales, excluding share-based compensation.Cost of sales for the three months ended June 30, 2024 increased as compared to the same period in 2023, primarily due to an increase in Tyvaso DPI royalty expense."

Sales • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Respiratory Diseases

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=24 | Enrolling by invitation | Sponsor: Mayo Clinic | Trial completion date: Jun 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

UNITED THERAPEUTICS CORPORATION ANNOUNCES FULL ENROLLMENT OF THE TETON 2 STUDY OF INHALED TREPROSTINIL FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (United Therapeutics Press Release) - "Top line data expected in the second half of 2025...United Therapeutics Corporation...announced full enrollment of the TETON 2study evaluating the use of Tyvaso (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF)....Patients in any of the TETON program studies may use nebulized Tyvaso alone as a monotherapy or in combination with one background therapy approved for the treatment of IPF or PPF. Enrollment in TETON 1 and TETON PPF is ongoing."

Enrollment closed • Enrollment status • P3 data: top line • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

TETON-2: Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=597 | Active, not recruiting | Sponsor: United Therapeutics | Recruiting ➔ Active, not recruiting

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