Anavex Life Sciences has announced the withdrawal of its European marketing authorisation application (MAA) for blarcamesine for the treatment of early Alzheimer’s disease.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had previously found on 11 December 2025 that the benefits of blarcamesine did not outweigh its risks and had therefore issued a negative opinion on the drug. Anavex requested a re-examination of the decision, continuing to engage with the CHMP in further discussions. In its press release issued on 25 March, Anavex stated that the CHMP had said that “it would not be in a position to issue a positive opinion for the application at this time”. As a result, the company has withdrawn its MAA for blarcamesine.
Blarcamesine is a small molecule drug delivered as a daily, oral capsule. It acts by enhancing autophagy, a cellular process that removes damaging waste products from the brain. This mechanism of action differs from that of anti-amyloid therapies, with no risk of severe side effects linked to brain microbleeds or swelling. In its December 2025 opinion, the CHMP concluded that the main clinical study did not provide clear evidence of benefit across the key measures of cognition and daily functioning. They also stated that the available safety data were limited, with a number of participants stopping treatment due to side effects. Anavex requested re-examination of the opinion on 17 December.
Alzheimer Europe recognises that this news will come as a disappointment for people living with Alzheimer’s disease in Europe. The organisation’s recent position statement on blarcamesine supported the granting of a conditional marketing authorisation, re-evaluated on a yearly basis, with an obligation for the company to conduct an additional phase III clinical trial and to collect real-world evidence from patients being treated in European countries.
Alzheimer Europe will continue to monitor clinical trial developments and welcomes the commitment of Anavex to gathering additional data and conducting further analyses. The organisation hopes that these and other ongoing clinical trials will lead to positive results. Alzheimer Europe also calls for continued research into much-needed, additional treatment options, including symptomatic treatments for people in more advanced stages of the disease. The organisation remains committed to a holistic approach to Alzheimer’s disease and dementia where treatment should be provided alongside counselling, support and adequate care of people with dementia and their carers throughout the disease process.
Read the Anavex press release: https://anavex.com/news/anavex-blarcamesine-eu-regulatory-update-alzheimers/
