On 19 November 2014, orphan designation (EU/3/14/1361) was granted by the European Commission to Inventiva, France, for 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis.

This medicine is now known as lanifibranor.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2020 on request of the Sponsor.

Key facts

Active substance
1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid (lanifibranor)
Disease / condition
Treatment of systemic sclerosis
Date of first decision
EU designation 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

50 route de Dijon
21121 Daix
Tel. +33 3 80 44 75 00
Fax +33 3 80 44 75 61

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.

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