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    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
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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
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    • 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
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      (treprostinil prodrug)
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    • Unikidney
      (xenokidney)
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      (xenoheart)
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      (Lung Lobes)
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      (3DAP Lungs)
  • Device
    • Centralized Ex-Vivo Lung Evaluation System (EVLP)
    • RemoLife (treprostinil)
  • Complete Pipeline
  • Program Updates
PIPELINE

Near-term

  • Tyvaso DPI™ (inhaled treprostinil)
  • Centralized Ex-Vivo Lung Evaluation System (EVLP)
  • RemoLife (treprostinil)

Mid-term

  • PERFECT (inhaled treprostinil)
  • OreniPro™ (once-daily, oral treprostinil prodrug)
  • RemoPro™ (treprostinil prodrug)
  • TETON (inhaled treprostinil)
  • ADVANCE Studies Ralinepag (IP receptor agonist)
  • Unikidney (xenokidney)
  • Uniheart (xenoheart)
  • Unilobe (Lung Lobes)
  • SAPPHIRE Aurora-GT™ eNOS Gene Therapy
  • Genetically-Enhanced Mesenchymal stem cells (GEM)

Long-term

  • U-Lung (3DAP Lungs)
ADVANCE Studies Ralinepag (IP receptor agonist)
  • Description
  • Targeted Indication
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  • Product Information
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NCE / Novel Biologics therapeutic platform
ADVANCE Studies Ralinepag (IP receptor agonist)
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ADVANCE OUTCOMES – Phase 3, randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy of ralinepag in subjects with pulmonary arterial hypertension (PAH) by evaluating ralinepag’s impact on time to clinical worsening in patients with PAH. ADVANCE CAPACITY is an additional Phase 3 clinical trial to evaluate ralinepag’s impact on exercise capacity in patients with PAH.

Ralinepag is a novel, once daily IP receptor agonist undergoing Phase 3 studies for PAH. Ralinepag has demonstrated superiority and improved pharmacology over selexipag in nonclinical studies and proof of concept in a Phase 2 clinical trial in PAH.

Ralinepag is a development-stage product not approved for sale in any jurisdiction.
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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
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.

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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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.