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)

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Withdrawn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
Bahnstrasse 42-46
61381 Friedrichsdorf
Hassia
Germany
E-mail: trio@triomedicines.com

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

DateUpdate
March 2023Please note that this product was withdrawn from the Union Register of orphan medicinal products in March 2023 on request of the Sponsor.

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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