EU/3/20/2387: Orphan designation for the treatment of primary biliary cholangitis



On 6 January 2021, orphan designation EU/3/20/2387 was granted by the European Commission to GenKyoTex S.A, France, for setanaxib for the treatment of primary biliary cholangitis.

Key facts

Active substance
Intended use
Treatment of primary biliary cholangitis
Orphan designation status
EU designation number
Date of designation

GenKyoTex S.A.
Forum 2
218 Avenue Marie Curie
Archamps Technopole
74166 Saint-Julien-en-Genevois Cedex
Tel. +33 456448110

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
August 2022 The sponsor's name was changed from GenKyoTex S.A. to Calliditas Therapeutics France S.A.S in August 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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