EU/3/20/2320: Orphan designation for the treatment of Menkes disease

Copper histidinate


On 21 August 2020, orphan designation EU/3/20/2320 was granted by the European Commission to CambPharma Solutions (CY) Limited, Cyprus, for copper histidinate (also known as CUTX-101) for the treatment of Menkes disease.

Key facts

Active substance
Copper histidinate
Intended use
Treatment of Menkes disease
Orphan designation status
EU designation number
Date of designation

CambPharma Solutions (CY) Limited
D. Vrachimis Building
Agiou Athanasiou 59
Agios Athanasios, Limassol 4102
Tel. +441480465755

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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