EU/3/15/1459: Orphan designation for the treatment of amyotrophic lateral sclerosis



On 19 March 2015, orphan designation (EU/3/15/1459) was granted by the European Commission to Impasara Ltd, United Kingdom, for enoxacin for the treatment of amyotrophic lateral sclerosis.

The sponsorship was transferred to Dr. Regenold GmbH, Germany, in October 2015.

In July 2017, Dr. Regenold GmbH Development Regulatory Market Access changed name to Dr. Regenold GmbH.

The sponsor's name was updated in September 2021.

Key facts

Active substance
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
EU designation number
Date of designation

Regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Tel: +49 7632 8226 0
Fax: +49 7642 8226 555

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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