Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-18FDA Approved: STERILE DILUENT FOR TREPROSTINIL — Supplemental Application (Dr.Reddy's Laboratories Inc.,)
The FDA approved a supplemental application from Dr. Reddy's Laboratories for a sterile diluent (water) to accompany treprostinil in injecta…
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CLINICAL_TRIALS trial_result · 2023-09-01Clinical Trial Update: Safety and Efficacy of BIA 5-1058 in PAH [Phase 2]
Phase 2 trial results for BIA 5-1058 in pulmonary arterial hypertension have been completed, reporting safety and efficacy outcomes.
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FDA approval · 2023-08-29FDA Approved: SILDENAFIL CITRATE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' sildenafil citrate tablets as an original application (ANDA216383), establishing a generic version of …
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CLINICAL_TRIALS trial_result · 2023-08-23Clinical Trial Update: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) [Phase 3]
Phase 3 STELLAR trial evaluating sotatercept for pulmonary arterial hypertension completed with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-08-07Clinical Trial Update: EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension [Phase 4]
Phase 4 trial evaluating switched therapy in pulmonary arterial hypertension; results posted in 2023.
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FDA approval · 2023-06-06FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc. This action updates the a…
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FDA approval · 2023-05-26FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc. The submission status is…
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CLINICAL_TRIALS trial_result · 2023-05-19Clinical Trial Update: Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST [Phase 3]
A Phase 3 trial of bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension was terminated, with results p…
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CLINICAL_TRIALS withdrawal · 2023-05-15Clinical Trial Update: Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease [Phase 3]
Phase 3 trial evaluating PDE5 inhibitors in single-ventricle patients with pulmonary hypertension was withdrawn.
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FDA approval · 2023-04-24FDA Approved: TADALAFIL — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for tadalafil filed by Camber Pharmaceuticals, Inc. This action grants an updated approval related t…
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CLINICAL_TRIALS trial_result · 2023-04-19Clinical Trial Update: A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension [Phase 2]
Phase 2 pediatric dose-confirmation study of selexipag for pulmonary arterial hypertension has posted results; the trial is currently not re…
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CLINICAL_TRIALS trial_result · 2023-04-19Clinical Trial Update: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) [Phase 2]
Phase 2 clinical trial update for sotatercept in pulmonary arterial hypertension (PAH) has completed with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-04-18Clinical Trial Update: Apabetalone for Pulmonary Arterial Hypertension [Phase 2]
Phase 2 clinical trial update for apabetalone in pulmonary arterial hypertension is ongoing with unknown status.
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FDA approval · 2023-03-07FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for REMODULIN (treprostinil) submitted by United Therapeutics Corporation.
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CLINICAL_TRIALS trial_result · 2023-03-06Clinical Trial Update: A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) [Phase 2]
Phase 2 trial of ubenimex in pulmonary arterial hypertension has completed; results were posted in 2023.
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FDA approval · 2023-03-03FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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FDA approval · 2023-03-03FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
FDA approves a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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CLINICAL_TRIALS trial_result · 2023-02-27Clinical Trial Update: Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH) [Phase 2]
Phase 2 clinical trial update for inhaled nitric oxide (INOpulse DS) in pulmonary arterial hypertension (PAH) has completed enrollment/statu…
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CLINICAL_TRIALS withdrawal · 2023-02-21Clinical Trial Update: Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric [Phase 3]
Phase 3 trial investigating inhaled nitric oxide in PAH patients with LTOT use was withdrawn.
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CLINICAL_TRIALS trial_result · 2023-02-21Clinical Trial Update: Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH [Phase 3]
A long-term extension study for inhaled nitric oxide (iNO) in pulmonary arterial hypertension is ongoing (Phase 3).
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CLINICAL_TRIALS trial_result · 2023-02-10Clinical Trial Update: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension [Phase 2]
Phase 2 clinical trial of sotatercept for pulmonary arterial hypertension has completed with posted results.
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FDA approval · 2023-02-01FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., with the action relating to mod…
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CLINICAL_TRIALS trial_result · 2023-02-01Clinical Trial Update: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain [Phase 4]
Phase 4 trial update on lidocaine subcutaneous infusion to control treprostinil-related site pain in pulmonary arterial hypertension.
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FDA approval · 2023-01-31FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Pfizer Laboratories Div Pfizer Inc.
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CLINICAL_TRIALS trial_result · 2023-01-25Clinical Trial Update: Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH [Phase 3]
A Phase 3 trial evaluating pulsed, inhaled nitric oxide vs placebo in symptomatic pulmonary arterial hypertension was terminated; results po…