Investigator Sponsored Studies


Investigator Sponsored Studies

United Therapeutics provides support for both interventional and non-interventional research in our therapeutic areas of interest:

  • pulmonary arterial hypertension (World Health Organization [WHO] Group 1 pulmonary hypertension [PH])
  • pulmonary hypertension due to lung diseases and/or hypoxia (WHO Group 3 PH);
  • respiratory diseases and disorders (e.g., COVID-19, acute lung injury [ALI], interstitial lung disease); and
  • lung transplantation; and
  • prostacyclin research.

The research must be intended to contribute knowledge to the medical community, and the budget must be reasonable and appropriate for the proposed work. In considering applications for support, United Therapeutics will also consider the expertise of the proposed principal investigator and any sub-investigators, including their experience in the relevant therapeutic area, demonstrated ability to successfully conduct clinical trials, and available resources.

 

United Therapeutics Investigator Sponsored Study program strategic interests:

  • Novel treatment approaches to acute and chronic respiratory diseases – including, but not limited to, ALI related to COVID-19
  • Preclinical prostacyclin pharmacology and mechanism of action (across WHO groups) – synergistic treatment pathway approaches, prostacyclin receptor pharmacology
  • New treatment approaches and adverse event management strategies associated with prostacyclin class therapies for PH – multimodal therapy, synergistic treatment pathway approaches, transitions, treprostinil adverse events
  • Personalized medicine – pharmacogenomics, “-omics”, biomarkers, individualized drug therapy, diagnostic strategies for pulmonary diseases
  • Novel indications and study endpoints – hemodynamics, cardiopulmonary function/structure and imaging, biomarkers
  • Real-world data analyses and other health outcomes research in PH – claims database analyses, electronic health record analyses, health economic studies

 

Available materials through the United Therapeutics Investigator Sponsored Study program:

  • Unexisome™ (bone marrow mesenchymal stem cell-derived exosomes), subject to supply constraints*
  • Treprostinil, active pharmaceutical ingredient
  • Remodulin© (treprostinil) Injection (1, 2.5, 5, 10 mg/mL concentration vials)
  • Tyvaso© (treprostinil) Inhalation Solution (0.6 mg/mL ampules)
  • Orenitram© (treprostinil) extended-release tablets
  • Next generation infusion pumps to administer Remodulin©

*Unexisome is a composition of complex biologic vesicles containing cytokines, enzymes, and ribonucleic acid in development for the treatment of bronchopulmonary dysplasia. Unexisome is a development-stage product not approved for sale in any jurisdiction.

 

Data Query Program

The purpose of the Data Query program is to allow investigators to propose independent post-hoc analyses of United Therapeutics clinical data sets.

 

Your proposal will be considered by a cross-functional committee that meets routinely. To apply, please visit www.utcrequests.com. For assistance, please email ISS@unither.com.