On 21 March 2014, orphan designation (EU/3/13/1228) was granted by the European Commission to Intercept Italia S.R.L., Italy, for obeticholic acid for the treatment of primary sclerosing cholangitis.

The sponsorship was transferred to Intercept Pharma Ltd, United Kingdom, in June 2016.

Key facts

Active substance
Obeticholic acid
Disease / condition
Treatment of primary sclerosing cholangitis
Date of decision
Orphan decision number

Review of designation

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

Sponsor's contact details

Intercept Pharma Ltd
1st Floor
2 Pancras Square
London N1C 4AG
United Kingdom
Tel. +44 (0)20 3805 7542

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.

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