EU/3/15/1560: Orphan designation for the treatment of Duchenne muscular dystrophy

N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide (edasalonexent)


On 9 October 2015, orphan designation (EU/3/15/1560) was granted by the European Commission to FGK Representative Service GmbH, Germany, for N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide for the treatment of Duchenne muscular dystrophy.

This medicine is now known as edasalonexent.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2021 upon request of the Sponsor.


Key facts

Active substance
N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide (edasalonexent)
Intended use
Treatment of Duchenne muscular dystrophy
Orphan designation status
EU designation number
Date of designation

FGK Representative Service GmbH
Heimeranstrasse 35
80339 Munich
Tel. +49 8989 311922

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:

How useful was this page?

Add your rating