EU/3/19/2158: Orphan designation for the treatment of pulmonary arterial hypertension

(S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib)

Table of contents


On 29 May 2019, orphan designation (EU/3/19/2158) was granted by the European Commission to MWB Consulting S.A.R.L., France, for (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (also known as GB002) for the treatment of pulmonary arterial hypertension.

Key facts

Active substance
(S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib)
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
EU designation number
Date of designation

Gossamer Bio 002 Limited
10 Earlsfort Terrace
Dublin 2 D02 T380
Co. Dublin


Update history

September 2022The sponsorship was transferred from MWB Consulting S.A.R.L., France, to Gossamer Bio 002 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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