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WHO Group 1 pulmonary hypertension is also known as pulmonary arterial hypertension (PAH) and is distinguished by high blood pressure that specifically occurs in the vessels that supply the lungs. This is distinct from more generalized hypertension which is characterized by high blood pressure in vessels throughout the body. In PAH, the blood vessels in the lung stiffen and become narrower, which increases the pressure in the arteries and causes the heart to pump harder in order to pass blood through them. Over time, the added stress from heightened blood pressure in the lungs can cause the heart to weaken. Patients with PAH commonly experience symptoms such as shortness of breath, fatigue, chest pain, dizziness and/or fainting. These patients can also experience difficulties in completing normal activities such as climbing stairs.
Product
Therapeutic Platform
Remodulin®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Please click here to see important safety information
Status
Devices / FDA ClearedProduct
Therapeutic Platform
Tyvaso®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 3Status
Phase 3INCREASE – Phase 3 clinical trial with Tyvaso® (treprostinil) for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
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Remodulin®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Please click here to see important safety information
Status
Devices / FDA Approved*Implantable System for intravenous delivery of Remodulin® (treprostinil).
*FDA requires that certain conditions of Medtronic’s PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions of approval.
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Therapeutic Platform
Remodulin®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Devices / Preparing NDA ResubmissionPrefilled, pre-programmed, single-use PatchPump® for subcutaneous administration of treprostinil.
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Tyvaso®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Pulmonary Hypertension (PH) WHO Group 3Status
Phase 3Dry Powder Inhaled (DPI) treprostinil in a small handheld device for the treatments of pulmonary arterial hypertension (PAH), and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
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Therapeutic Platform
Remodulin®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Devices / Prototype developmentTherapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
Devices / Pivotal TrialEx-vivo lung perfusion (EVLP) is a process used to measure lung function prior to transplant.
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Therapeutic Platform
Tyvaso®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 3Status
Phase 3Phase 3 clinical trial with Tyvaso® (treprostinil) for the treatment of pulmonary hypertension due to chronic obstructive pulmonary disease (PH-COPD).
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Therapeutic Platform
Tyvaso®Targeted Indication
Chronic Fibrosing Interstitial Lung DiseaseStatus
Phase 3A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Patients with Chronic Fibrosing Interstitial Lung Disease.
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Orenitram®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Phase 1Oral prodrug being developed to provide increased tolerability and convenience through a once-daily dosing regimen.
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Therapeutic Platform
Remodulin®Targeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Phase 1Prodrug of treprostinil that is being developed to reduce site pain associated with subcutaneous delivery of treprostinil.
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Therapeutic Platform
NCE / Novel BiologicsTargeted Indication
Bronchopulmonary Dysplasia (BPD)Status
Phase 1Unexisome™ (exosomes) biologic vesicle therapy treatment for bronchopulmonary dysplasia (BPD).
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NCE / Novel BiologicsTargeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Phase 3An IP receptor agonist that is a next-generation, once-a-day oral therapy that targets the prostacyclin pathway for patients with pulmonary arterial hypertension (PAH).
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Therapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
Pre-clinicalProduct
Therapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
Pre-clinicalProduct
Therapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
Pre-clinicalUnilobe is a decellularized porcine lung scaffold that have been recellularized with human allogeneic lung cells.
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NCE / Novel BiologicsTargeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Status
Phase 2Phase 2 clinical trial to establish the efficacy and safety of repeat dosing of autologous endothelial progenitor cells (EPCs) transfected with human endothelial nitric oxide synthase (eNOS) and expanded ex-vivo in patients with PAH on top of conventional treatments.
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NCE / Novel BiologicsTargeted Indication
Pulmonary Hypertension (PH) WHO Group 1 (PAH) / SepsisStatus
Pre-clinicalEnhanced Mesenchymal stem cells for the treatment of sepsis and pulmonary arterial hypertension (PAH).
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Therapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
DevicesThe TAL is a biomedical device that is being developed to provide respiratory assistance for patients who cannot receive a tissue-based lung, or who need partial or short-term lung support.
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Therapeutic Platform
Organ ManufacturingTargeted Indication
End-stage Organ DiseaseStatus
Pre-clinicalU-Lung is a 3D printed lung scaffold that is cellularized with either allogenic cells or a patient’s own cells.
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