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.

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)
Disease / condition
Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of first decision
EU designation number

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.

Sponsor's contact details

Regulis Consulting Europe Limited
The Black Church
Saint Mary's Place
Dublin 7 DO7 P4AX
Tel: +353 1 231 4691

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;

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