EU/3/15/1550: Orphan designation for the treatment of idiopathic pulmonary fibrosis

3-pentylbenzeneacetic acid sodium salt


On 9 October 2015, orphan designation (EU/3/15/1550) was granted by the European Commission to ProMetic BioTherapeutics Ltd, United Kingdom, for 3-pentylbenzeneacetic acid sodium salt for the treatment of idiopathic pulmonary fibrosis.

The sponsorship was transferred to ProMetic Pharma SMT Limited, United Kingdom, in June 2016.

The sponsorship was transferred to Prometic Pharma SMT B.V., The Netherlands, in May 2019.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in February 2022 on request of the Sponsor.

Key facts

Active substance
3-pentylbenzeneacetic acid sodium salt
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
EU designation number
Date of designation

Prometic Pharma SMT B.V.
Barbara Strozzilaan 201
1083 HN Amsterdam
Tel: +44 7394560778

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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