EU/3/15/1588: Orphan designation for the treatment of gastro-entero-pancreatic neuroendocrine tumours
(R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide)
Table of contents
Overview
On 14 December 2015, orphan designation (EU/3/15/1588) was granted by the European Commission to Trio Medicines Ltd, United Kingdom, for (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (also known as TR2-A) for the treatment of gastro-entero-pancreatic neuroendocrine tumours.
The sponsorship was transferred to Regulis Consulting Europe Limited, Ireland, in April 2019.
The sponsorship was transferred to YES Pharmaceutical Development Services GmbH , Germany, in February 2021.
Key facts
Active substance |
(R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide)
|
Intended use |
Treatment of gastro-entero-pancreatic neuroendocrine tumours
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/15/1588
|
Date of designation |
14/12/2015
|
Sponsor |
YES Pharmaceutical Development Services GmbH |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
This medicine is now known as ceclazepide.
Update history
Date | Update |
---|---|
March 2023 | Please note that this product was withdrawn from the Union Register of orphan medicinal products in March 2023 on request of the Sponsor. |
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: