Pulmonary Arterial Hypertension

FDA approval · 2025-02-28

FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc. The approval involves change…

CLINICAL_TRIALS trial_result · 2025-02-27

Clinical Trial Update: A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) [Phase 3]

Phase 3 trial update for sotatercept in Japanese patients with pulmonary arterial hypertension; the study is completed and results have been…

FDA approval · 2025-02-21

FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

FDA approved a supplemental application for Bosentan from Sun Pharmaceutical, approving a generic version of bosentan for treating pulmonary…

FDA approval · 2025-02-21

FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)

FDA approved a supplemental application for Bosentan by Actavis Pharma, enabling a generic version of the pulmonary arterial hypertension me…

FDA approval · 2025-02-21

FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

The FDA approved a supplemental application for TRACLEER (bosentan) by Actelion Pharmaceuticals US, Inc.

FDA approval · 2025-02-21

FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

The FDA approved a supplemental application for TRACLEER (bosentan) filed by Actelion Pharmaceuticals US, Inc., resulting in updated labelin…

FDA approval · 2025-02-21

FDA Approved: BOSENTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

The FDA approved a supplemental application for bosentan submitted by Lupin Pharmaceuticals, Inc.

CLINICAL_TRIALS trial_result · 2025-02-21

Clinical Trial Update: A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007) [Phase 2, Phase 3]

A Phase 2/3 study (INSIGNIA-PAH) evaluated the inhaled sGC stimulator Frespaciguat (MK-5475) for pulmonary arterial hypertension; the trial …

FDA approval · 2025-02-21

FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

FDA approved a supplemental application to authorize a generic bosentan product (BOSENTAN) from Zydus Pharmaceuticals USA Inc.

CLINICAL_TRIALS research · 2025-02-20

Clinical Trial Update: Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH [Phase 3]

Phase 3 trial evaluating parenteral treprostinil and riociguat on right ventriculo-vascular coupling and morphology in advanced pulmonary ar…

FDA approval · 2025-02-19

FDA Approved: TADALAFIL — Supplemental Application (Alembic Pharmaceuticals Inc.)

FDA approved a supplemental application for tadalafil from Alembic Pharmaceuticals Inc., enabling a generic tadalafil product. The approval …

CLINICAL_TRIALS trial_result · 2025-02-13

Clinical Trial Update: Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension [Phase 1]

A Phase 1 study evaluating carnitine consumption and augmentation in pulmonary arterial hypertension has completed, with results posted.

CLINICAL_TRIALS trial_result · 2025-02-12

Clinical Trial Update: Olaparib for PAH: a Multicenter Clinical Trial [Phase 1, Phase 2]

A multicenter Phase 1/Phase 2 trial of olaparib for pulmonary arterial hypertension has been terminated. The sponsor is Laval University.

CLINICAL_TRIALS trial_result · 2025-02-11

Clinical Trial Update: Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children With Heart Disease [NA]

This document reports the completion of a clinical trial evaluating the safety and effectiveness of a virtual pediatric cardiac rehabilitati…

CLINICAL_TRIALS trial_result · 2025-02-10

Clinical Trial Update: A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)

This completed real-world clinical trial update assesses the effectiveness, safety, and use of riociguat in United States patients with pulm…

FDA approval · 2025-02-05

FDA Approved: BOSENTAN — Original Application (Lupin Pharmaceuticals, Inc.)

The FDA approved Lupin Pharmaceuticals' original application for a generic Bosentan, enabling a generic version of the endothelin receptor a…

CLINICAL_TRIALS trial_result · 2025-02-04

Clinical Trial Update: Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH) [Phase 3]

A Phase 3 trial evaluating the efficacy and safety of bosentan in sickle cell disease patients with pulmonary arterial hypertension was term…

CLINICAL_TRIALS trial_result · 2025-02-04

Clinical Trial Update: Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology [Phase 4]

Phase 4 trial update shows completion of study evaluating the effects of Tracleer (bosentan) on pulmonary arterial hypertension related to E…