EU/3/17/1882: Orphan designation for the treatment of growth hormone deficiency

Ibutamoren mesilate


On 20 June 2017, orphan designation (EU/3/17/1882) was granted by the European Commission to Richardson Associates Regulatory Affairs Ltd., United Kingdom, for ibutamoren mesilate (also known as MK-0677) for the treatment of growth hormone deficiency.

The sponsorship was transferred to Richardson Associates Regulatory Affairs Ltd, Ireland, in December 2018 and to Agos Healthcare Limited, Ireland, in December 2020.

The sponsor's address was updated in September 2021.

Key facts

Active substance
Ibutamoren mesilate
Intended use
Treatment of growth hormone deficiency
Orphan designation status
EU designation number
Date of designation

Agos Healthcare Limited
Castle Chambers
6 Castle Street
Co. Cork
T12 T25W
Tel: +353 21 206 9222

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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