EU/3/16/1721: Orphan designation for the prevention of graft loss in pancreatic islet transplantation

L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide)


On 29 August 2016, orphan designation (EU/3/16/1721) was granted by the European Commission to Araim Pharma Europe Ltd, United Kingdom, for L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (also known as ARA 290) for the prevention of graft loss in pancreatic islet transplantation.

This medicine is now known as cibinetide.

The sponsorship was transferred to Araim Pharmaceuticals Europe Limited, Ireland, in April 2019.

Key facts

Active substance
L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide)
Intended use
Prevention of graft loss in pancreatic islet transplantation
Orphan designation status
EU designation number
Date of designation

Araim Pharmaceuticals Europe Limited
Riverside One
Sir John Rogerson's Quay
Dublin 2
D02 X576
Tel.:  +353 1 829 0000


Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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