Remodulin is under clinical development by United Therapeutics and currently in Phase II for Ischemia Reperfusion Injury. According to GlobalData, Phase II drugs for Ischemia Reperfusion Injury does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Remodulin LoA Report. Buy the report here.
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Remodulin overview
Treprostinil (Remodulin, Treprost) is a prostacyclin analog acts as antihypertensive agent. It is formulated as injectable solution for intravenous and subcutaneous route of administration and solution for inhalational route of administration. Remodulin is indicated for the treatment of pulmonary arterial hypertension for newborn and in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH, PAH associated with congenital systemic -to-pulmonary shunts or PAH associated with connective tissue diseases.
Treprostinil (Remodulin) is also under development for the treatment of ischemia-reperfusion injury during kidney transplantation. It is administered by intravenous route.
It was also under development for the treatment of pulmonary hypertension in pediatrics.
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 Remodulin’s drug-specific PTSR and LoA scores, buy the report here.
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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.
