EU/3/18/2130: Orphan designation for the treatment of pulmonary arterial hypertension



On 11 January 2019, orphan designation (EU/3/18/2130) was granted by the European Commission to Arena Pharmaceuticals Limited, Ireland, for ralinepag for the treatment of pulmonary arterial hypertension.

The sponsorship was transferred to Unither Therapeutik GmbH, Germany in April 2019.

The sponsor's address was updated in July 2021.

Key facts

Active substance
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
EU designation number
Date of designation

United Therapeutics Ireland Limited
6th Floor
South Bank House
Barrow Street
Dublin 4
D04 TR29

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

Date Update
January 2023 The sponsorship was transferred from Unither Therapeutik GmbH, Germany, to United Therapeutics Ireland Limited, Ireland

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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