On 12 October 2017, orphan designation (EU/3/17/1937) was granted by the European Commission to Quintiles Ireland Limited, Ireland, for 4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one (also known as RX-3117) for the treatment of pancreatic cancer.
In May 2018 the sponsor, Quintiles Ireland Limited changed name to IQVIA RDS Ireland Limited.
EU/3/17/1937: Public summary of opinion on orphan designation: 4-Amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one for the treatment of pancreatic cancer (PDF/122.43 KB)
First published: 15/01/2018
Last updated: 15/01/2018
|Disease / condition||
Treatment of pancreatic cancer
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
East Point Business Park
Tel. +353 1819 5100
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.