On 8 November 2017, orphan designation (EU/3/17/1936) was granted by the European Commission to Worldwide Clinical Trials Limited, United Kingdom, for 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea (also known as DCC-2618) for the treatment of gastrointestinal stromal tumours.
The sponsorship was transferred to Pharma Gateway AB, Sweden, in May 2018.
The sponsorship was transferred to Deciphera Pharmaceuticals (Netherlands) B.V., Netherlands, in July 2020.
The sponsor’s address was updated in August 2021.
Ripretinib has been authorised in the EU as Qinlock since 18 November 2021.
Treatment of gastrointestinal stromal tumours
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Review of designation
Documents related to this orphan designation evaluation
EU/3/17/1936: Public summary of opinion on orphan designation: 1-[4-Bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for the treatment of gastrointestinal stromal tum... (PDF/126.97 KB)
First published: 15/01/2018
Last updated: 15/01/2018
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: