EU/3/16/1712: Orphan designation for the treatment of idiopathic pulmonary fibrosis

2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-alpha]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile (ziritaxestat)


This medicine is now known as ziritaxestat.

On 29 August 2016, orphan designation (EU/3/16/1712) was granted by the European Commission to Galapagos NV, Belgium, for 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-alpha]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile for the treatment of idiopathic pulmonary fibrosis.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in April 2021 on request of the Sponsor.

Key facts

Active substance
2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-alpha]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile (ziritaxestat)
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
EU designation number
Date of designation

Galapagos N.V.
Generaal De Wittelaan L11 A3
2800 Mechelen Antwerp
Tel. +32 1534 2900

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:

  • 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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