EU/3/12/1026: Orphan designation for the treatment of calciphylaxis

Hexasodium phytate


On 17 July 2012, orphan designation (EU/3/12/1026) was granted by the European Commission to Sanifit Laboratoris, S.L., Spain, for hexasodium phytate for the treatment of calciphylaxis.

In October 2015, Sanifit Laboratoris, S.L. changed name to Laboratoris Sanifit S.L. In April 2021, Laboratoris Sanifit S.L. changed name to Sanifit Therapeutics S.A.

Key facts

Active substance
Hexasodium phytate
Intended use
Treatment of calciphylaxis
Orphan designation status
EU designation number
Date of designation

Vifor France
Tour Franklin La Defense 8
100 Terrasse Boieldieu
92042 Paris La Defense Cedex
E-mail :

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

Date Update
November 2022 The sponsorship was transferred from Sanifit Therapeutics S.A., Spain to Vifor France, France, in November 2022.

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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