Treprostinil is under clinical development by United Therapeutics and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Treprostinil’s likelihood of approval (LoA) and phase transition for Idiopathic Pulmonary Fibrosis took place on 25 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Treprostinil Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Treprostinil overview

Treprostinil (Tyvaso, Tyvaso DPI) is a prostacyclin analog acts as antihypertensive agent. Tyvaso is formulated as powder and solution for inhalation. Tyvaso is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

It is under development for pulmonary arterial hypertension in Japan and for pulmonary hypertension associated with interstitial lung disease (ILD) including combined pulmonary fibrosis, emphysema (CPFE) and chronic obstructive pulmonary disease (COPD) globally and idiopathic pulmonary fibrosis in US. It was also under development for chronic thromboembolic pulmonary hypertension, pulmonary arterial hypertension in EU.

United Therapeutics overview

United Therapeutics develops and commercializes innovative pharmaceutical products for the treatment of cardiovascular disorders, particularly pulmonary arterial hypertension, and infectious diseases. The company’s products consist of prostacyclin analogues including Remodulin (treprostinil) injection; Tyvaso (treprostinil) inhalation solution; and Orenitram (treprostinil). Adcirca (tadalafil) is a phosphodiesterase type 5 (PDE-5) inhibitor and Unituxin (dinutuximab), a monoclonal antibody for oncologic applications, are the other products. Its product candidates include monoclonal antibodies (mAbs), glycobiology antiviral agents and cell-based therapies. The company also develops engineered lungs for transplantation in pre-clinical stage. It manufactures products in its facility in Silver Spring, Maryland. It markets its products in the US, Europe, South America and Israel. United Therapeutics is headquartered in Silver Spring, Maryland, the US.

Quick View Treprostinil LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Treprostinil
Administration Pathway
  • Inhalational
Therapeutic Areas
  • Cardiovascular
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.