What treatments for Alzheimer are currently FDA-approved as of 2025?
Executive summary
As of 2025 the FDA’s approved arsenal for Alzheimer’s disease includes new anti-amyloid monoclonal antibodies for early-stage illness, longstanding symptom‑relief drugs, and a few recent approvals for administration options and behavioral symptoms; these therapies change the treatment landscape but apply to specific patient groups and carry important safety and monitoring requirements [1] [2] [3]. Disease‑modifying anti‑amyloid antibodies — notably lecanemab (Leqembi) and donanemab (marketed as Kisunla/Kisunla in FDA material) — are approved for people with mild cognitive impairment or mild dementia due to Alzheimer’s, while cholinesterase inhibitors, memantine and newer formulations or indications address symptoms and associated behaviors [4] [5] [1] [3].
1. The disease‑modifying anti‑amyloid drugs now approved
Lecanemab (Leqembi) was converted from accelerated to traditional FDA approval after a confirmatory Phase 3 trial showed slowed clinical decline for early Alzheimer’s; the label specifies use in people with mild cognitive impairment or mild dementia and requires confirmation of brain amyloid pathology [2] [4]. Donanemab received FDA approval as Kisunla (donanemab‑azbt) for initiation in patients with mild cognitive impairment or mild dementia and is administered as an intravenous infusion every four weeks in the studied population, with trials showing statistically significant slowing of clinical decline [5]. Peer‑reviewed pipeline reviews and 2025 summaries also characterize these monoclonal antibodies as approved anti‑amyloid immunotherapies that remove high‑molecular‑weight amyloid forms and rely on biomarkers for both selection and proof of target engagement [1] [6].
2. Symptom‑management drugs remain foundational
Cholinesterase inhibitors and memantine remain standard therapies for symptomatic management of cognitive and functional decline; in recent years new formats have expanded options, such as the once‑weekly donepezil transdermal patch (Adlarity) approved in 2022, widening tolerability and delivery choices for clinicians and patients [3]. These agents do not claim to modify underlying disease biology in the way anti‑amyloid antibodies do, but they remain central to care for many patients and are part of the 2025 clinical playbook alongside behavioral and lifestyle strategies [3] [6].
3. Treatments for neuropsychiatric/behavioral symptoms and new drugs with limited public data
The FDA cleared brexpiprazole (Rexulti) specifically for agitation in Alzheimer’s after a Phase 3 trial demonstrated a modest benefit, representing a regulatory acknowledgement of the severe impact behavioral symptoms can have on patients and caregivers [3]. Company announcements and smaller reporting note newer agents — for example Zunveyl (benzgalantamine) — promoted by their developers as an approved galantamine‑like option, but coverage in peer‑reviewed or regulatory sources is more limited here and readers should treat single‑company press claims with caution until corroborated by FDA or independent clinical publications [7].
4. Who qualifies, how patients are selected, and safety caveats
Anti‑amyloid antibodies are indicated for early AD populations with biomarker confirmation of amyloid pathology, and approvals and clinical practice rely heavily on PET or cerebrospinal fluid testing to establish that target [1] [4]. These agents carry risks — notably amyloid‑related imaging abnormalities (ARIA), including brain swelling or microhemorrhages — which have driven careful labeling, monitoring protocols, and clinician guidance about follow‑up imaging and patient selection [8] [9]. Regulatory documents for Kisunla document trial populations, dosing regimens and statistically significant, but numerically modest, benefits on integrated clinical scales [5].
5. The practical reality and the edges of current reporting
The available literature and FDA materials paint a picture of a treatment era defined by targeted immunotherapies plus established symptomatic medicines, but real‑world access, cost, optimal long‑term duration, and equitable availability remain active debates; professional groups and research centers emphasize that biomarkers, monitoring frameworks, and further research are still needed to optimize benefit and safety [9] [1]. Reporting from industry and advocacy outlets celebrates new launch formats and patient‑assistance programs, yet independent analyses and ongoing trials will continue to refine who benefits most and how best to combine or sequence these treatments [10] [11].