EU/3/16/1657: Orphan designation for the treatment of biliary tract cancer

(R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride (derazantinib)


This medicine is now known as derazantinib.

On 30 May 2016, orphan designation (EU/3/16/1657) was granted by the European Commission to Coté Orphan Consulting UK Limited, United Kingdom, for (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride for the treatment of biliary tract cancer.

The sponsorship was transferred to Basilea Pharmaceutica Deutschland GmbH, Germany, in May 2019.

Key facts

Active substance
(R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride (derazantinib)
Intented use
Treatment of biliary tract cancer
Orphan designation status
EU designation number
Date of designation

Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Loerrach
Tel. +49 7621 1639475

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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