In 2025, the world will be closely watching developments regarding treatments for Alzheimer’s.
Clinical trials of Alzheimer’s drugs have already seen big successes and failures. Now, after years of efforts and massive investments of money, we are starting to bear the fruit of the successes. New treatments have come to market.
Two of the newest treatments for Alzheimer’s are already available in the USA. Each drug has two names, its brand name and its generic name.
Lecanemab is sold under the brand name Leqembi, and donanemab is branded as Kisunla. Both drugs lower brain amyloid levels in patients, slowing down Alzheimer’s in the early stages. Notwithstanding, they cannot cure the disease or even reverse it. Both of the drugs include side effects such as brain bleeding and brain swelling.
Brand Name | Generic Name | Company |
Leqembi | lecanemab | Biogen Inc. and Eisai Co. |
Kisunla | donanemab | Ely Lilly & Co. |
The drugs are both gaining momentum across the United States.
The top developments ahead for the year 2025 include:
1. Leqembi
Patients on Leqembi at this time take it as an infusion. Patients need to go to the hospital or a clinic to be treated.
There is a new version that can be administered at home. In the next few months, Biogen hopes to get FDA approval for the injectable formulation. Patients would then be able to get treated at home, instead of having to travel to the hospital.
A separate research company called BioArctic AB originally discovered Leqembi. Royalties are paid to BioArctic for Leqembi.
2. Kisunla
The FDA approved Eli Lilly’s Kisunla treatment in July 2024. Doctors and patients realize Kisunla is playing catch-up with Leqembi, and are keeping a close eye on how Kisunla performs against its earlier competitor. While there are important differences between the two, they basically work with similar effects.
3. Remternetug
Ely Lilly is rushing to introduce an additional Alzheimer’s drug called remternetug. Remternetug’s plan is similar to Leqembi’s, in that two versions are expected, one via infusion and the second via injection. It is currently finishing up clinical trials that will assess amyloid plaque clearance and safety. If it proves to be a better treatment option than Kisunla, it could have a profound affect on the landscape of available treatments. Remternetug’s results are expected in late 2025 or early 2026.
4. Semaglutide
In the exploding anti-obesity / anti-diabetic drug market, patients taking semaglutide showed themselves to be at significantly reduced risk of Alzheimer’s. The drugs maker, Novo Nordisk, has started clinical trials for Alzheimer’s and expects results from the trial in the later half of 2025.
5. Trontinemab
Roche finished the early phases of trontinemab clinical trials, showing it to be safe and ready for advanced trials. The drug deploys a brain shuttle technology, slipping past the blood-brain barrier to clear amyloid. More data needs to come in over the next few months before Roche decides whether to proceed with late-stage trials. The drug is an upgraded version of gantenerumab, a Roche drug that was not sufficiently effective in treating Alzheimer’s in earlier trials.
6. Bepranemab
Under consideration by Belgian biotech firm UCB SA is the continued development of the drug bepranemab. The experimental drug has been shown to ease cognitive decline. In addition, it slows accumulation of tau proteins, the second culprit that works alongside amyloid plaque to cause Alzheimer’s.
Next Events on the Calendar
Mid-January: The European Union is expected by most experts to approve Leqembi. The European Union’s EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization to Leqembi for treating mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copy of ApoE4 gene.
January 25, 2025: The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for January 25, 2025. Approval would allow patients who have completed the biweekly IV initiation phase to start receiving a monthly IV dose that maintains effective drug concentration to sustain the treatment of Alzheimer’s with Leqembi.
Keep an eye on the Alzheimer’s Weekly’s newsletter for regular updates on how these drugs are performing and progressing.