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  • Therapeutic Platform
    • Remodulin®
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  • Targeted Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
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  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • Tyvaso DPI™
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • Unilobe
      (Lung Lobes)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • RemoLife (treprostinil)
  • Complete Pipeline
  • Program Updates
Menu
  • Therapeutic Platform
    • Remodulin®
    • Tyvaso®
    • Orenitram®
    • NCE / Novel Biologics
    • Organ Manufacturing
  • Targeted Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
    • Pulmonary Hypertension (PH) WHO Group 3
    • Idiopathic Pulmonary Fibrosis (IPF)
    • Sepsis
    • End-stage Organ Disease
  • Status
    • Pre-clinical
    • Phase 1
    • Phase 3
    • Registration Phase Study
    • Devices
  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • Tyvaso DPI™
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • Unilobe
      (Lung Lobes)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • RemoLife (treprostinil)
  • Complete Pipeline
  • Program Updates
PIPELINE

Welcome to UTHR Pipeline

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model.

5

THERAPEUTIC PLATFORMS

Our next-generation therapies are designed to address the unmet needs of patients living with conditions such as PAH, PH, and end-stage organ disease.

VISION

Our pipeline phases are islands we must reach in our journey to better patient outcomes. Driven by our vision of cures, we build bridges between them and travel towards a future of individualized medicine via gene therapy and organ manufacturing.

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  • Near-term
  • Mid-term
  • Long-term
TETON
(inhaled treprostinil)
RemoLife
(treprostinil)
U-Lung
(3DAP Lungs)
Uniheart
(xenoheart)
Unikidney
(xenokidney)
Genetically-Enhanced Mesenchymal stem cells
(GEM)
Unilobe
(Lung Lobes)
OreniPro™
(once-daily, oral treprostinil prodrug)
ADVANCE Studies Ralinepag
(IP receptor agonist)
Centralized Ex-Vivo Lung Evaluation System
(EVLP)
PERFECT
(inhaled treprostinil)
Tyvaso DPI™
(inhaled treprostinil)
SAPPHIRE Aurora-GT™ eNOS Gene Therapy
RemoPro™
(treprostinil prodrug)

Program Updates

September 7, 2021

United Therapeutics Presents Tyvaso DPI™ BREEZE Clinical Data At The European Respiratory Society International Congress 2021

READ MORE

June 16, 2021

United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review

READ MORE

June 3, 2021

United Therapeutics Announces First Patient Enrolled in Phase 3 TETON Study of Tyvaso in Patients With Idiopathic Pulmonary Fibrosis

READ MORE

Our Therapeutic Platforms are vibrant and change regularly. Please refer to our most recent public filings for the latest updates.

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© Copyright 2021 United Therapeutics Corporation | All rights reserved. | US-CORP-0173 UTHR

Menu
  • Therapeutic Platform
    • Remodulin®
    • Tyvaso®
    • Orenitram®
    • NCE / Novel Biologics
    • Organ Manufacturing
  • Targeted Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
    • Pulmonary Hypertension (PH) WHO Group 3
    • Idiopathic Pulmonary Fibrosis (IPF)
    • Sepsis
    • End-stage Organ Disease
  • Status
    • Pre-clinical
    • Phase 1
    • Phase 3
    • Registration Phase Study
    • Devices
  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • Tyvaso DPI™
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • Unilobe
      (Lung Lobes)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • RemoLife (treprostinil)
  • Complete Pipeline
  • Program Updates
Near-term
Mid-term
Long-term
Near-term
Tyvaso DPI™ (inhaled treprostinil)

Product

Tyvaso DPI™
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)Pulmonary Hypertension (PH) WHO Group 3

Status

Phase 3

Dry 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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Centralized Ex-Vivo Lung Evaluation System (EVLP)

Product

Centralized Ex-Vivo Lung Evaluation System
(EVLP)

Therapeutic Platform

Organ Manufacturing

Targeted Indication

End-stage Organ Disease

Status

Devices / Pivotal Trial

Ex-vivo lung perfusion (EVLP) is a process used to measure lung function prior to transplant.

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RemoLife (treprostinil)
RemoLife (treprostinil)

Product

RemoLife
(treprostinil)

Therapeutic Platform

Remodulin®

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Devices / Prototype development

Next-generation ambulatory micro-infusion pumps with smartphone compatibility.

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Mid-term
PERFECT (inhaled treprostinil)

Product

PERFECT
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 3

Status

Phase 3

Phase 3 clinical trial with Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension due to chronic obstructive pulmonary disease (PH-COPD).

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OreniPro™ (once-daily, oral treprostinil prodrug)
OreniPro™ (oral treprostinil prodrug)

Product

OreniPro™
(once-daily, oral treprostinil prodrug)

Therapeutic Platform

Orenitram®

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase 1

Oral prodrug being developed to provide increased tolerability and convenience through a once-daily dosing regimen.

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RemoPro™ (treprostinil prodrug)
RemoPro™ (treprostinil prodrug)

Product

RemoPro™
(treprostinil prodrug)

Therapeutic Platform

Remodulin®

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase 1

Prodrug of treprostinil that is being developed to reduce site pain associated with subcutaneous delivery of treprostinil.

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TETON (inhaled treprostinil)

Product

TETON
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Targeted Indication

Idiopathic Pulmonary Fibrosis (IPF)

Status

Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Patients with Idiopathic Pulmonary Fibrosis (IPF).

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ADVANCE Studies Ralinepag (IP receptor agonist)

Product

ADVANCE Studies Ralinepag
(IP receptor agonist)

Therapeutic Platform

NCE / Novel Biologics

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase 3

An 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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Unikidney (xenokidney)

Product

Unikidney
(xenokidney)

Therapeutic Platform

Organ Manufacturing

Targeted Indication

End-stage Organ Disease

Status

Pre-clinical

Xenokidneys – Revivicor Transgene Biologic.

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Uniheart (xenoheart)
Uniheart

Product

Uniheart
(xenoheart)

Therapeutic Platform

Organ Manufacturing

Targeted Indication

End-stage Organ Disease

Status

Pre-clinical

Xenohearts – Revivicor Transgene Biologic.

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Unilobe (Lung Lobes)

Product

Unilobe
(Lung Lobes)

Therapeutic Platform

Organ Manufacturing

Targeted Indication

End-stage Organ Disease

Status

Pre-clinical

Unilobe is a decellularized porcine lung scaffold that have been recellularized with human allogeneic lung cells.

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SAPPHIRE Aurora-GT™ eNOS Gene Therapy

Product

SAPPHIRE Aurora-GT™ eNOS Gene Therapy

Therapeutic Platform

NCE / Novel Biologics

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Registration phase study

Registration phase study in Canada 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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Genetically-Enhanced Mesenchymal stem cells (GEM)
Genetically-Enhanced Mesenchymal stem cells (GEMS)

Product

Genetically-Enhanced Mesenchymal stem cells
(GEM)

Therapeutic Platform

NCE / Novel Biologics

Targeted Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH) / Sepsis

Status

Pre-clinical

Enhanced Mesenchymal stem cells for the treatment of sepsis and pulmonary arterial hypertension (PAH).

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Long-term
U-Lung (3DAP Lungs)

Product

U-Lung
(3DAP Lungs)

Therapeutic Platform

Organ Manufacturing

Targeted Indication

End-stage Organ Disease

Status

Pre-clinical

U-Lung is a 3D printed lung scaffold that is cellularized with either allogenic cells or a patient’s own cells.

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Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a scarring disease of the lungs of an unknown (idiopathic) cause and is the most common of the idiopathic interstitial pneumonias. IPF is characterized by the progressive loss of the ability of the lungs to absorb oxygen, ultimately resulting in respiratory failure and death. While the precise causes of IPF remain unknown, IPF rarely presents before age 50 and can be associated with cigarette smoking and certain genetic dispositions. In addition, some evidence suggests that gastroesophageal reflux (acid reflux, or heartburn), certain viral infections, air pollution, and some exposures in the workplace may be risk factors for IPF. IPF is estimated to affect approximately 100,000 patients in the United States and the median survival of patients with IPF ranges from 2 to 3 years.

Neuroblastoma

Neuroblastoma is a rare cancer that primarily affects children. Neuroblastoma occurs when immature nerve cells (also called neuroblasts) fail to normally develop into mature nerve cells. These immature nerve cells then multiply, leading to the growth of a cancerous mass of cells (tumor). Neuroblastoma tumors can originate anywhere in the body but are often found in the abdomen or belly and usually involve the adrenal glands, which sit on top of the kidney. The chest, neck, hips, bone marrow, and pelvis are other sites that are commonly affected by neuroblastoma. Once diagnosed, neuroblastoma can be further classified according to the level of risk (i.e., low, intermediate or high-risk) it may pose to the patient. Risk classification is based on factors known to affect prognosis (i.e., chance of recovery) and the risk of the neuroblastoma returning after treatment (i.e., relapse). The factors that impact risk classification include, age of diagnosis, stage of disease, and other characteristics of the tumor.

Pulmonary Arterial Hypertension (PAH) WHO Group 1

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.