EU/3/07/459: Orphan designation for the treatment of narcolepsy

1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride


On 10 July 2007, orphan designation (EU/3/07/459) was granted by the European Commission to Bioprojet, France, for 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride for the treatment of narcolepsy.

In November 2015, Bioprojet changed name to Bioprojet Pharma.

Update: 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride (Wakix) has been authorised in the EU since 31 March 2016. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy.

More information on Wakix can be found in the European public assessment report (EPAR).

Key facts

Active substance
1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride
Intended use
Treatment of narcolepsy
Orphan designation status
EU designation number
Date of designation
Bioprojet Pharma
9 rue Rameau
75002 Paris
Tel. + 33 1 4703 6633
Fax + 33 1 4703 6630

Review of designation

During its meeting of 16 to 18 February 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/459 for Wakix (pitolisant1) as an orphan medicinal product for the treatment of narcolepsy. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with narcolepsy. The COMP recommended that the orphan designation of the medicine be maintained2.

1Previously known as 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride.

2The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Wakix (pitolisant) for the treatment of narcolepsy (PDF/80.07 KB)


    First published: 20/04/2016
    Last updated: 20/04/2016

  • Patients' organisations

    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

    • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

    • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

    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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