EMA/OD/0000149115 - orphan designation for treatment of amyotrophic lateral sclerosis
cutamesine
OrphanHuman
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
Key facts
- Active substance
- cutamesine
- Intended use
- Treatment of amyotrophic lateral sclerosis
- Orphan designation status
- Positive
- EU designation number
- EMA/OD/0000149115
- Date of designation
- Sponsor
3R Pharma Consulting GmbH
EMA list of opinions on orphan medicinal product designation
EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:
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: