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Treprostinil - United Therapeutics Corporation

Drug Profile

Treprostinil - United Therapeutics Corporation

Alternative Names: 15AU; 15AU81; ARD-1500; ARD-1550; BW 15AU; BW 15AU81; BW A15AU; LRX 15; MD 711; MD-0701; OreniCell; OreniLeft; Orenitram; Remodulin; Sustained-release treprostinil - United Therapeutics; TransCon treprostinil; Treprost; Treprostenol; Treprostinil diolamine; Treprostinol; Tresprostinol diethanolamine; Tyvaso; U 62840; Uniprost; UT 15; UT-15C; UT-15C SR

Latest Information Update: 24 Oct 2019

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At a glance

  • Originator GlaxoSmithKline; Pfizer
  • Developer Ascendis Pharma; Ferrer; Lee's Pharmaceutical; Mochida Pharmaceutical; United Therapeutics Corporation
  • Class Antihypertensives; Prostaglandins; Skin disorder therapies; Small molecules; Vasodilators
  • Mechanism of Action Epoprostenol receptor agonists; Platelet aggregation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pulmonary arterial hypertension; Systemic scleroderma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pulmonary arterial hypertension
  • Phase II Systemic scleroderma
  • Discontinued Cancer; Heart failure; Peripheral ischaemia

Most Recent Events

  • 22 Oct 2019 The US FDA approves the sNDA for treprostinil label to include data from the phase III FREEDOM-EV study
  • 17 May 2019 Addition adverse events and efficacy data from the phase III FREEDOM-EV trial in pulmonary arterial hypertension presented at the 115th International Conference of the American Thoracic Society (ATS-2019)
  • 25 Mar 2019 First generic equivalent available in USA for Pulmonary arterial hypertension
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