On 29 May 2019, orphan designation (EU/3/19/2159) was granted by the European Commission to Pharma Gateway AB, Sweden, for (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (also known as FT-2102) for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Clinipace GmbH, Germany, in May 2020.
Treatment of acute myeloid leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Rigel Pharmaceuticals B.V.
|January 2023||The sponsorship was transferred from Clinipace GmbH, Germany to Rigel Pharmaceuticals B.V., The Netherlands.|
Documents related to this orphan designation evaluation
EU/3/19/2159: Public summary of opinion on orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile for the treatment of acute myeloid leukaemia (PDF/190.12 KB)
First published: 09/08/2019
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: