EU/3/16/1673: Orphan designation for the treatment of fragile X syndrome

pyridoxine / l-pyroglutamic acid

Table of contents


On 27 June 2016, orphan designation (EU/3/16/1673) was granted by the European Commission to FGK Representative Service Ltd, United Kingdom, for pyridoxine and L-pyroglutamic acid (the combination is also called metadoxine) for the treatment of fragile X syndrome.

Key facts

Active substance
  • pyridoxine
  • l-pyroglutamic acid
Intended use
Treatment of fragile X syndrome
Orphan designation status
EU designation number
Date of designation
FGK Representative Service Ltd.
c/o EMW, Seebeck House
1 Seebeck Place
Knowlhill, Milton Keynes
Buckinghamshire MK5 8FR
United Kingdom
Tel. +44 (0)20 3769 0905
Fax +44 (0)33 0808 0587

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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