EU/3/12/1043: Orphan designation for the diagnosis of positive folate-receptor status in ovarian cancer

N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide)


Please note that this product was withdrawn from the Union Register of orphan medicinal products in December 2021 on request of the sponsor.

On 10 September 2012, orphan designation (EU/3/12/1043) was granted by the European Commission to Endocyte Europe B.V., the Netherlands, for N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine to be used with folic acid (etarfolatide) for the diagnosis of positive folate-receptor status in ovarian cancer.

The sponsorship was transferred to Voisin Consulting S.A.R.L., France, in December 2016.

In October 2021, Voisin Consulting S.A.R.L. changed name to Voisin Consulting Life Sciences.

This medicine is now known as etarfolatide. 


Key facts

Active substance
N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide)
Medicine name
Intended use
Diagnosis of positive folate-receptor status in ovarian cancer
Orphan designation status
EU designation number
Date of designation

Voisin Consulting Life Sciences 
64 Avenue Pierre Grenier
92100 Boulogne-Billancourt
Tel. +33 1413 18300

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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