EU/3/14/1362: Orphan designation for the treatment of idiopathic pulmonary fibrosis

1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid (lanifibranor)


On 19 November 2014, orphan designation (EU/3/14/1362) was granted by the European Commission to Inventiva, France, for 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of idiopathic pulmonary fibrosis.

This medicine is now known as lanifibranor.

Key facts

Active substance
1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid (lanifibranor)
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
EU designation number
Date of designation
50 route de Dijon
21121 Daix
Tel. +33 3 80 44 75 00
Fax +33 3 80 44 75 61

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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