EU/3/20/2283: Orphan designation for the treatment of neonatal encephalopathy

Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24


On 4 June 2020, orphan designation EU/3/20/2283 was granted by the European Commission to Clinipace GmbH, Germany, for Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24 (also known as PIC1-dPEG24) for the treatment of neonatal encephalopathy.

Key facts

Active substance
Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24
Intended use
Treatment of neonatal encephalopathy
Orphan designation status
EU designation number
Date of designation

Clinipace GmbH
Helfmann-Park 10
65760 Eschborn
Tel: +1 757 901 0460

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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