EU/3/11/934: Orphan designation for the treatment of idiopathic pulmonary fibrosis

4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol (tanzisertib)


This medicine is now known as tanzisertib.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in January 2018 on request of the sponsor.

On 9 December 2011, orphan designation (EU/3/11/934) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for 4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol for the treatment of idiopathic pulmonary fibrosis.

Key facts

Active substance
4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol (tanzisertib)
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
EU designation number
Date of designation
Celgene Europe Ltd
1 Longwalk Road
Stockley Park
Uxbridge UB11 1BD
United Kindgom
Telephone: +44 208 831 8300
Telefax: +44 208 831 8301

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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