EU/3/18/1982: Orphan designation for the treatment of pulmonary arterial hypertension

N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide

Table of contents

Overview

On 22 February 2018, orphan designation (EU/3/18/1982) was granted by the European Commission to ATXA Therapeutics Limited, Ireland, for N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide (also known as NTP42) for the treatment of pulmonary arterial hypertension.

The sponsor’s address was updated in April 2020.

Key facts

Active substance
N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
Positive
EU designation number
EU/3/18/1982
Date of designation
22/02/2018
Sponsor

ATXA Therapeutics Limited
Temple Chambers
3 Burlington Road
Ballsbridge
Dublin 4
Co. Dublin D04 RD68
Ireland 
Tel. +353 877765446
E-mail: therese.kinsella@atxatherapeutics.com

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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