Key findings
- ClinicalTrials.gov lists 1,646 1 interventional drug or biologic studies in Alzheimer's disease; 280 2 are active and 332 3 are Phase 3.
- 269 4 started between January 2023 and September 2026: 128 5 with a US site and 46 6 with a China site.
- Annual starts were 87 7 in 2021 and 78 8 in 2025, a flat trend despite two approvals.
- Anti-amyloid antibodies appear in 21 9 of the studies started since 2023.
Momentum: approvals did not bring a trial boom
Alzheimer's drug trial starts were 66 10 in 2020, 87 7 in 2021 and 81 11 in 2022. They dipped to 58 12 in 2023 and recovered only to 78 8 in 2025. That is unlike oncology and metabolic tracks, where approvals were followed by fast growth.
The United States hosts most studies: 34 13 of the 2025 starts had a US site, compared with 16 14 with a China site. China's share is rising slowly, helped by blood-biomarker programmes and domestic companies. Industry sponsorship has fallen as a share of new studies, while academic groups and prevention networks carry more of the work.
Alzheimer's drug trial starts have been flat for five years
Interventional Alzheimer's disease drug studies by start year; a study with sites in both countries counts in both lines
View the underlying data
| Series | Period | Type | Value |
|---|---|---|---|
| All studies | 2025 | Actual | 78 |
| All studies | 2024 | Actual | 71 |
| All studies | 2023 | Actual | 58 |
| All studies | 2022 | Actual | 81 |
| All studies | 2021 | Actual | 87 |
| All studies | 2020 | Actual | 66 |
| With a US site | 2025 | Actual | 34 |
| With a US site | 2024 | Actual | 38 |
| With a US site | 2023 | Actual | 30 |
| With a US site | 2022 | Actual | 50 |
| With a US site | 2021 | Actual | 56 |
| With a US site | 2020 | Actual | 37 |
| With a China site | 2025 | Actual | 16 |
| With a China site | 2024 | Actual | 14 |
| With a China site | 2023 | Actual | 5 |
| With a China site | 2022 | Actual | 11 |
| With a China site | 2021 | Actual | 12 |
| With a China site | 2020 | Actual | 6 |
Live registry counts retrieved 2026-09-27. Studies registered only outside ClinicalTrials.gov, including many China-only trials, are not counted.
Mechanisms: the second wave of amyloid and the first real tau tests
Anti-amyloid antibodies appear in 21 9 studies started since 2023. Most are extensions, new populations or new formulations of approved drugs. Lecanemab appears in 9 26 and donanemab in 8 27. Roche's trontinemab, which uses a transferrin-receptor "brain shuttle" to raise brain exposure, appears in 2 28. It is now in Phase 3, including a study started in 2026 in cognitively unimpaired people at risk of the disease.
Tau-targeted therapies appear in 6 29 new studies, including antisense oligonucleotides that lower tau production. GLP-1 receptor agonists appear in 5 30. Novo Nordisk reported on 24 November 2025 that its two Phase 3 semaglutide studies in early Alzheimer's disease, evoke and evoke+, did not meet their primary endpoint (Novo Nordisk), which cools this line of work.
Neuropsychiatric symptoms, such as agitation and psychosis, are a separate and more tractable market. Drugs aimed at them appear in 7 31 new studies.
Anti-amyloid antibodies lead new mechanism-specific trials
Interventional studies started since January 2023, by asset or class; a study can count in more than one bar
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| Anti-amyloid antibodies (all) | ClinicalTrials.gov | Actual | 21 |
| Lecanemab | ClinicalTrials.gov | Actual | 9 |
| Donanemab | ClinicalTrials.gov | Actual | 8 |
| Agitation and psychosis in Alzheimer's | ClinicalTrials.gov | Actual | 7 |
| Tau-targeted therapies | ClinicalTrials.gov | Actual | 6 |
| GLP-1 receptor agonists | ClinicalTrials.gov | Actual | 5 |
| Trontinemab (brain shuttle) | ClinicalTrials.gov | Actual | 2 |
Live registry counts retrieved 2026-09-27. Name and code matching can miss studies registered under other identifiers.
Approvals
- Kisunla (donanemab), approved 2 July 2024 (BLA 761248)
- Leqembi (lecanemab), 6 January 2023 (BLA 761269)
- Aduhelm (aducanumab), 7 June 2021 (BLA 761178); Biogen announced its discontinuation in January 2024 (Biogen)
The approved antibodies slow decline modestly and need amyloid confirmation, infusion or injection and MRI monitoring for amyloid-related imaging abnormalities. Those practical burdens, more than efficacy alone, limit uptake and define what a better drug must fix.
What it means for founders and R&D teams
- Solve a practical problem of the approved drugs. Examples are lower ARIA risk, subcutaneous or less frequent dosing, and better brain penetration. These are clearer goals than a new mechanism with an unproven link to cognition.
- Use blood biomarkers to cut trial cost. Plasma p-tau assays make screening cheaper and enable prevention trials. Companies that design trials around them can move faster.
- Treat symptom drugs as a separate business. Agitation, psychosis and sleep in dementia have shorter trials and clearer endpoints than disease modification.
- Expect a high failure rate. Of the tracks in this series, Alzheimer's has the most studies stopped for lack of efficacy. Stage-gate funding and early human biomarker evidence of target engagement are essential.
Methodology and limitations
Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies in Alzheimer's disease with a drug or biologic intervention. It therefore includes some diagnostic radiotracer studies and repurposed generic drugs.
Mechanism bars match intervention names and are restricted to Alzheimer's studies. They are small numbers and can move with a few registrations. The comparison of efficacy-related stops across tracks comes from a review of the stop reasons recorded in the registry and is not a separate published statistic. Semaglutide trial results and product discontinuations come from company announcements. Approval dates come from Drugs@FDA.
Approved, Phase 3 and Phase 2 drugs
The named drugs in this report by their furthest stage: US approval from Drugs@FDA, phase from ClinicalTrials.gov. Sort any column or download CSV; each date and trial number links to its source.
| Drug | Stage | First FDA approval | Latest trial at that stage | Trial start | Trial |
|---|---|---|---|---|---|
| AXS-05 (dextromethorphan-bupropion) | Approved | 18 Aug 2022 Auvelity · NDA 215430 | NCT06736509 Phase 3 · Terminated | 21 Nov 2024 | An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study |
| Aducanumab | Approved | 7 Jun 2021 Aduhelm · BLA 761178 | NCT05310071 Phase 3 · Terminated | 2 Jun 2022 | A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease |
| Brexpiprazole | Approved | 10 Jul 2015 Rexulti · NDA 205422 | NCT03594123 Phase 3 · Completed | 11 Oct 2018 | A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type |
| Donanemab | Approved | 2 Jul 2024 Kisunla · BLA 761248 | NCT06996730 Phase 2/3 · Recruiting | 8 Jul 2026 | A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease |
| Lecanemab | Approved | 6 Jan 2023 Leqembi, Leqembi Iqlik · BLA 761269 | NCT03887455 Phase 3 · Active, not recruiting | 27 Mar 2019 | A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease |
| Blarcamesine | Phase 3 | Not FDA approved | NCT04314934 Phase 2/3 · Completed | 10 Oct 2019 | OLE of Phase 2b/3 Study ANAVEX2-73-AD-004 |
| Buntanetap | Phase 3 | Not FDA approved | NCT07757204 Phase 2/3 · Not yet recruiting | 21 Sep 2026 | An Open-label Long-term Safety Study of Buntanetap in Participants With AD |
| E2814 / etalanetug (anti-tau) | Phase 3 | Not FDA approved | NCT05269394 Phase 2/3 · Active, not recruiting | 22 Dec 2021 | Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU) |
| Gantenerumab | Phase 3 | Not FDA approved | NCT05256134 Phase 3 · Terminated | 19 Apr 2022 | A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD) |
| Pimavanserin | Phase 3 | 29 Apr 2016 Nuplazid · NDA 207318 For another use; no current US label for Alzheimer's disease | NCT03325556 Phase 3 · Completed | 27 Sep 2017 | Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis |
| Remternetug | Phase 3 | Not FDA approved | NCT06653153 Phase 3 · Active, not recruiting | 24 Oct 2024 | A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) |
| Semaglutide | Phase 3 | 5 Dec 2017 Ozempic, Rybelsus, Wegovy · NDA 209637 For another use; no current US label for Alzheimer's disease | NCT05891496 Phase 3 · Completed | 20 Jun 2023 | A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease |
| Trontinemab | Phase 3 | Not FDA approved | NCT07170150 Phase 3 · Active, not recruiting | 12 Nov 2025 | A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease |
| Valiltramiprosate / ALZ-801 | Phase 3 | Not FDA approved | NCT04770220 Phase 3 · Completed | 19 May 2021 | An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects |
| Xanomeline-trospium | Phase 3 | Not FDA approved | NCT06947941 Phase 3 · Recruiting | 25 Mar 2026 | A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5) |
| Bepranemab (anti-tau) | Phase 2 | Not FDA approved | NCT04867616 Phase 2 · Completed | 9 Jun 2021 | A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD) |
| Masupirdine | Phase 2 | Not FDA approved | NCT02580305 Phase 2 · Completed | Sep 2015 | SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study |
How this report is checked
Every figure is a count from ClinicalTrials.gov, the US National Library of Medicine's trial registry. Each links to a StatOrigin record that keeps the exact query, so anyone can run it again; how the counts are made and what they leave out is set out under Methodology and limitations above.
The development-stage table
Checked on 4 October 2026. A drug's US approval is the original approval of its first new drug application or biologics licence application in Drugs@FDA, read through the FDA's openFDA service, with the FDA approval letter where Drugs@FDA links one. A drug counts as approved here only if one of its current FDA labels names Alzheimer's disease in its Indications and Usage section. Cell and gene therapies are licensed by a different FDA centre (CBER) and are not in Drugs@FDA; an approval for one of them is shown only where it was checked by hand against the FDA's product page. Approvals outside the United States — by the European Medicines Agency or China's NMPA, for example — are not shown. The phase is the highest phase among the drug's interventional ClinicalTrials.gov records. The trial shown is the most recently started one at that phase whose title names the drug, or, where none does, the most recently started one that lists it.
Writing and review
Written by StatOrigin editorial with AI assistance. Each count is checked automatically against the registry's own response before it is published. No named clinical reviewer has checked this report yet. Report an error through the corrections page.
Not medical advice
This report describes research activity and regulatory status. It is not medical advice and does not say whether any medicine is safe or effective for any person. Trial activity is not evidence that a drug works. Decisions about treatment belong with a qualified health professional; for what a medicine is approved to treat, read its current FDA label.
Data behind this report
The industry hubs and indicator series these figures come from. Each page carries the full table, every source and the records this report does not quote.
Industry hubs
Indicator series
- Alzheimer's disease drug trial starts 21
- Active Alzheimer's disease drug trials 1
- Phase 3 Alzheimer's disease drug trials 1
- Registered interventional Alzheimer's disease drug trials 1
- Trial starts since 2023: Agitation and psychosis in Alzheimer's 1
- Trial starts since 2023: Anti-amyloid antibodies (all) 1
- Trial starts since 2023: Donanemab 1
- Trial starts since 2023: GLP-1 receptor agonists 1
- Trial starts since 2023: Lecanemab 1
- Trial starts since 2023: Tau-targeted therapies 1
- Trial starts since 2023: Trontinemab (brain shuttle) 1
Sources
Every figure in this report is a published StatOrigin record. The table lists the 31 cited statistics. Sort any column or download CSV. Open a record for APA, MLA, Chicago or BibTeX.
Cite this report
StatOrigin. (2026). Alzheimer's disease drugs: a flat pipeline in the middle of a scientific turn. https://statorigin.org/reports/alzheimers-disease-drug-pipeline-2026
Prefer citing the underlying statistic when you only need one figure. Published 26 September 2026 · updated 27 September 2026. Data licence: CC BY 4.0.