EU/3/20/2385: Orphan designation for the treatment of invasive candidiasis

Rezafungin acetate


On 6 January 2021, orphan designation EU/3/20/2385 was granted by the European Commission to Mundipharma Corporation (Ireland) Limited, Ireland, for rezafungin acetate for the treatment of invasive candidiasis.

Key facts

Active substance
Rezafungin acetate
Intended use
Treatment of invasive candidiasis
Orphan designation status
EU designation number
Date of designation

Mundipharma GmbH
De-Saint-Exupery-Strasse 10
60549 Frankfurt Am Main


Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

June 2022The sponsorship was transferred from Mundipharma Corporation (Ireland) Limited to Mundipharma GmbH, Germany 

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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