EU/3/19/2159: Orphan designation for the treatment of acute myeloid leukaemia

(S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib)

Table of contents


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.

Key facts

Active substance
(S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib)
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation

Rigel Pharmaceuticals B.V.
Avenue Ceramique 223
6221 KX Maastricht Limburg

Update history

January 2023The sponsorship was transferred from Clinipace GmbH, Germany to Rigel Pharmaceuticals B.V., The Netherlands.

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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