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  • Therapeutic Platform
    • Remodulin®
    • Tyvaso®
    • Orenitram®
    • NCE / Novel Biologics
    • Dinutuximab
    • Organ Manufacturing
  • Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
    • Pulmonary Hypertension (PH) WHO Group 3
    • Neuroblastoma
    • Idiopathic Pulmonary Fibrosis (IPF)
    • Bronchopulmonary Dysplasia (BPD)
    • Sepsis
    • Chronic Fibrosing Interstitial Lung Disease
    • Respiratory Failure Including Acute Respiratory Distress Syndrome (ARDS)
    • End-stage Organ Disease
  • Status
    • Pre-clinical
    • Phase I
    • Phase II
    • Phase III
    • Devices
  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • INCREASE
      (inhaled treprostinil)
    • BREEZE Treprostinil Technosphere®
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
    • LNG01 (formerly SM04646)
      (Wnt inhibitor)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • Unexisome™
      (exosomes)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • hu14.18K322A
      (humanized dinutuximab)
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unilobe
      (Lung Lobes)
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Remunity™
      (treprostinil)
    • Trevyent®
      (treprostinil sodium)
    • Implantable System for Remodulin®
      (treprostinil)
    • Accelerated Total Artificial Lung (TAL1)
    • RemoLife (treprostinil)
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • Total Artificial Lung
      (TAL)
  • Complete Pipeline
  • Program Updates
Menu
  • Therapeutic Platform
    • Remodulin®
    • Tyvaso®
    • Orenitram®
    • NCE / Novel Biologics
    • Dinutuximab
    • Organ Manufacturing
  • Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
    • Pulmonary Hypertension (PH) WHO Group 3
    • Neuroblastoma
    • Idiopathic Pulmonary Fibrosis (IPF)
    • Bronchopulmonary Dysplasia (BPD)
    • Sepsis
    • Chronic Fibrosing Interstitial Lung Disease
    • Respiratory Failure Including Acute Respiratory Distress Syndrome (ARDS)
    • End-stage Organ Disease
  • Status
    • Pre-clinical
    • Phase I
    • Phase II
    • Phase III
    • Devices
  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • INCREASE
      (inhaled treprostinil)
    • BREEZE Treprostinil Technosphere®
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
    • LNG01 (formerly SM04646)
      (Wnt inhibitor)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • Unexisome™
      (exosomes)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • hu14.18K322A
      (humanized dinutuximab)
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unilobe
      (Lung Lobes)
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Remunity™
      (treprostinil)
    • Trevyent®
      (treprostinil sodium)
    • Implantable System for Remodulin®
      (treprostinil)
    • Accelerated Total Artificial Lung (TAL1)
    • RemoLife (treprostinil)
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • Total Artificial Lung
      (TAL)
  • Complete Pipeline
  • Program Updates
PIPELINE

Welcome to UTHR Pipeline

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

6

THERAPEUTIC PLATFORMS

Our next-generation therapies are designed to address the unmet needs of patients living with conditions such as PAH, PH, cancer, 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.

list-iconCreated with Sketch.
  • Near-term
  • Mid-term
  • Long-term
TETON
(inhaled treprostinil)
Accelerated Total Artificial Lung
(TAL1)
hu14.18K322A
(humanized dinutuximab)
RemoLife
(treprostinil)
U-Lung
(3DAP Lungs)
Uniheart
(xenoheart)
Total Artificial Lung
(TAL)
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)
BREEZE Treprostinil Technosphere®
(inhaled treprostinil)
INCREASE
(inhaled treprostinil)
SAPPHIRE Aurora-GT™ eNOS Gene Therapy
LNG01
(Wnt inhibitor)
Unexisome™
(exosomes)
RemoPro™
(treprostinil prodrug)
Trevyent®
(treprostinil sodium)
Remunity™
(treprostinil)
Implantable System for Remodulin®
(treprostinil)

Program Updates

February 24, 2020

United Therapeutics Announces INCREASE Study Of Tyvaso® Meets Primary And All Secondary Endpoints

READ MORE

February 24, 2020

United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin®

READ MORE

January 24, 2019

United Therapeutics Announces Closing Of License Agreement With Arena Pharmaceuticals For Ralinepag

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 2020 United Therapeutics Corporation | All rights reserved. | US-CORP-0173 UTHR

Menu
  • Therapeutic Platform
    • Remodulin®
    • Tyvaso®
    • Orenitram®
    • NCE / Novel Biologics
    • Dinutuximab
    • Organ Manufacturing
  • Indication
    • Pulmonary Hypertension (PH) WHO Group 1 (PAH)
    • Pulmonary Hypertension (PH) WHO Group 3
    • Neuroblastoma
    • Idiopathic Pulmonary Fibrosis (IPF)
    • Bronchopulmonary Dysplasia (BPD)
    • Sepsis
    • Chronic Fibrosing Interstitial Lung Disease
    • Respiratory Failure Including Acute Respiratory Distress Syndrome (ARDS)
    • End-stage Organ Disease
  • Status
    • Pre-clinical
    • Phase I
    • Phase II
    • Phase III
    • Devices
  • Oral
    • OreniPro™
      (oral treprostinil prodrug)
    • ADVANCE Studies Ralinepag
      (IP receptor agonist)
  • Inhaled
    • INCREASE
      (inhaled treprostinil)
    • BREEZE Treprostinil Technosphere®
      (inhaled treprostinil)
    • PERFECT
      (inhaled treprostinil)
    • TETON (inhaled treprostinil)
    • LNG01 (formerly SM04646)
      (Wnt inhibitor)
  • Infused
    • RemoPro™
      (treprostinil prodrug)
    • Unexisome™
      (exosomes)
    • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
    • hu14.18K322A
      (humanized dinutuximab)
    • Genetically-Enhanced Mesenchymal stem cells (GEM)
  • Transplant
    • Unilobe
      (Lung Lobes)
    • Unikidney
      (xenokidney)
    • Uniheart
      (xenoheart)
    • U-Lung
      (3DAP Lungs)
  • Device
    • Remunity™
      (treprostinil)
    • Trevyent®
      (treprostinil sodium)
    • Implantable System for Remodulin®
      (treprostinil)
    • Accelerated Total Artificial Lung (TAL1)
    • RemoLife (treprostinil)
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • Total Artificial Lung
      (TAL)
  • Complete Pipeline
  • Program Updates
Near-term
Mid-term
Long-term
Near-term
Remunity™ (treprostinil)
Remunity product

Product

Remunity™
(treprostinil)

Therapeutic Platform

Remodulin®

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Please click here to see important safety information

Status

Devices / FDA Cleared

Pre-filled system for subcutaneous administration of Remodulin® (treprostinil).

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Trevyent® (treprostinil sodium)
Trevyent® (treprostinil sodium)

Product

Trevyent®
(treprostinil sodium)

Therapeutic Platform

Remodulin®

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Devices / Complete Response Letter (CRL) Under Review

Pre-filled, pre-programmed, single-use PatchPump® for subcutaneous administration of treprostinil.

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INCREASE (inhaled treprostinil)
INCREASE (inhaled treprostinil)

Product

INCREASE
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Indication

Pulmonary Hypertension (PH) WHO Group 3

Status

Phase III

INCREASE – Phase III clinical trial with Tyvaso® (treprostinil) for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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Implantable System for Remodulin® (treprostinil)
Synchromed-II Medtronic

Product

Implantable System for Remodulin®
(treprostinil)

Therapeutic Platform

Remodulin®

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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Accelerated Total Artificial Lung (TAL1)

Product

Accelerated Total Artificial Lung
(TAL1)

Therapeutic Platform

Organ Manufacturing

Indication

Respiratory Failure Including Acute Respiratory Distress Syndrome (ARDS)

Status

Devices

The TAL1 is a biomedical device being developed to provide respiratory support for patients with Respiratory Failure including Acute Respiratory Distress Syndrome (ARDS).

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BREEZE Treprostinil Technosphere® (inhaled treprostinil)

Product

BREEZE Treprostinil Technosphere®
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase III

Dry Powder Inhaled (DPI) treprostinil in a small handheld device for the treatment of pulmonary arterial hypertension (PAH).

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RemoLife (treprostinil)
RemoLife (treprostinil)

Product

RemoLife
(treprostinil)

Therapeutic Platform

Remodulin®

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®

Indication

Pulmonary Hypertension (PH) WHO Group 3

Status

Phase III

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

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TETON (inhaled treprostinil)

Product

TETON
(inhaled treprostinil)

Therapeutic Platform

Tyvaso®

Indication

Chronic Fibrosing Interstitial Lung Disease

Status

Phase III

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Inhaled Treprostinil in Patients with Chronic Fibrosing Interstitial Lung Disease.

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

Product

OreniPro™
(once-daily, oral treprostinil prodrug)

Therapeutic Platform

Orenitram®

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase I

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®

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase I

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

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Centralized Ex-Vivo Lung Evaluation System (EVLP)

Product

Centralized Ex-Vivo Lung Evaluation System
(EVLP)

Therapeutic Platform

Organ Manufacturing

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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Unexisome™ (exosomes)

Product

Unexisome™
(exosomes)

Therapeutic Platform

NCE / Novel Biologics

Indication

Bronchopulmonary Dysplasia (BPD)

Status

Phase I

Unexisome™ (exosomes) biologic vesicle therapy treatment for bronchopulmonary dysplasia (BPD).

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ADVANCE Studies Ralinepag (IP receptor agonist)

Product

ADVANCE Studies Ralinepag
(IP receptor agonist)

Therapeutic Platform

NCE / Novel Biologics

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase III

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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SAPPHIRE Aurora-GT™ eNOS Gene Therapy

Product

SAPPHIRE Aurora-GT™ eNOS Gene Therapy

Therapeutic Platform

NCE / Novel Biologics

Indication

Pulmonary Hypertension (PH) WHO Group 1 (PAH)

Status

Phase IIPhase III

Phase II/III 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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Unilobe (Lung Lobes)

Product

Unilobe
(Lung Lobes)

Therapeutic Platform

Organ Manufacturing

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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Unikidney (xenokidney)

Product

Unikidney
(xenokidney)

Therapeutic Platform

Organ Manufacturing

Indication

End-stage Organ Disease

Status

Pre-clinical

Xenokidneys – Revivicor Transgene Biologic.

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hu14.18K322A (humanized dinutuximab)
hu14.18K322A

Product

hu14.18K322A
(humanized dinutuximab)

Therapeutic Platform

Dinutuximab

Indication

Neuroblastoma

Status

Phase II

hu14.18K322A is a humanized monoclonal antibody targeting ganglioside 2 (GD2) that is currently in clinical development for the treatment of advanced stage high-risk neuroblastoma with St. Jude Children’s Research Hospital.

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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

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
LNG01 (Wnt inhibitor)

Product

LNG01
(Wnt inhibitor)

Therapeutic Platform

NCE / Novel Biologics

Indication

Idiopathic Pulmonary Fibrosis (IPF)

Status

Phase I

LNG01 is a small molecule inhibitor of the Wnt pathway for the treatment of idiopathic pulmonary fibrosis (IPF).

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Total Artificial Lung (TAL)
Total Artificial Lung (TAL)

Product

Total Artificial Lung
(TAL)

Therapeutic Platform

Organ Manufacturing

Indication

End-stage Organ Disease

Status

Devices

The 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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Uniheart (xenoheart)
Uniheart

Product

Uniheart
(xenoheart)

Therapeutic Platform

Organ Manufacturing

Indication

End-stage Organ Disease

Status

Pre-clinical

Xenohearts – Revivicor Transgene Biologic.

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U-Lung (3DAP Lungs)

Product

U-Lung
(3DAP Lungs)

Therapeutic Platform

Organ Manufacturing

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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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.