Treprostinil is under clinical development by United Therapeutics and currently in Phase III for Pulmonary Fibrosis. According to GlobalData, Phase III drugs for Pulmonary Fibrosis have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Treprostinil’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Treprostinil overview

Treprostinil (Tyvaso, Tyvaso DPI) is a prostacyclin analog acts as antihypertensive agent. Tyvaso is formulated as solution and dry powder for inhalational route of administration (DPI) . 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 progressive pulmonary fibrosis (PPF), 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 and pulmonary hypertension due to chronic obstructive pulmonary disease (PH-COPD).

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 analogs 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 the 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.

For a complete picture of Treprostinil’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.