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Ralinepag - United Therapeutics Corporation

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Drug Profile

Ralinepag - United Therapeutics Corporation

Alternative Names: APD-811

Latest Information Update: 26 Jun 2025

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At a glance

  • Originator Arena Pharmaceuticals
  • Developer United Therapeutics Corporation
  • Class Acetic acids; Antihypertensives; Benzene derivatives; Carbamates; Chlorobenzenes; Cyclohexanes; Ethers; Small molecules
  • Mechanism of Action Epoprostenol receptor agonists
  • Orphan Drug Status

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

    Yes - Pulmonary arterial hypertension
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Pulmonary arterial hypertension

Most Recent Events

  • 23 Jun 2025 United Therapeutics completes enrolment in the phase III ADVANCE OUTCOMES trial for Pulmonary arterial hypertension in USA, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, France, Greece, Hungary, Israel, South Korea, Poland, Romania, Singapore, Spain, Taiwan, Ukraine, United Kingdom (NCT03626688) (EudraCT2018-001187-33)
  • 17 May 2024 Interim efficacy and adverse events data from a phase III OLE trial in Pulmonary arterial hypertension presented at the 120th International Conference of the American Thoracic Society (ATS-2024)
  • 02 Aug 2023 United Therapeutics Corporation plans to launch ralinepag in pulmonary arterial hypertension

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