Agitation in Alzheimer's disease drug pipeline
- MeSH D011595
- Subtype of Alzheimer's disease
5 compounds from 5 companies are in active clinical development for agitation in alzheimer's disease, including 2 at Phase 3 or beyond.
Mechanisms: Small molecule (5)
Pipeline data compiled September 2026 · every fact sourced.
Upcoming readouts & recent results
Anticipated readout from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511, expected in 2H 2026. ↗
Anticipated initiation of a Phase 2 study of NMRA-511 in Alzheimer's disease agitation, planned for Q1 2027. ↗
Anticipated Phase 2 topline for ITI-1284 in agitation associated with Alzheimer's dementia (NCT06651567); primary completion targeted October 2027. ↗
Confirmatory TRANQUILITY In-Care Phase 3 (~150 patients, 60 mcg PRN, care setting) planned but not yet started as of Q1 2026. ↗
FDA approves AUVELITY (AXS-05) for agitation associated with dementia due to Alzheimer's disease — first non-antipsychotic approved ↗
NMRA-511 Phase 1b signal-seeking study in Alzheimer's disease agitation met its goal: clinically meaningful placebo-adjusted CMAI reductions (notably 7.6/5.6 points at weeks 6/8 in the elevated-anxiety subgroup), favorable safety, no somnolence/sedation. ↗
Phase 3 AXS-05 AD-agitation program complete: ACCORD-2 relapse-prevention positive (HR 0.276, P=.001); ADVANCE-2 supportive but missed primary endpoint ↗
Study 305 topline (2024-02-13): no statistically significant difference vs placebo on the CMAI primary; falls 8.6%/9.1% on AVP-786 vs 2.8% on placebo. The result that triggered termination of the AVP-786 program on 2024-05-22. ↗
Compounds in development (5)
| Compound | Company | Phase | Status | Mechanism |
|---|---|---|---|---|
| AXS-05 (dextromethorphan-bupropion)BTDPriority Review | Axsome Therapeutics, Inc. | Approved | Approved | NMDA receptor Antagonist |
| Dexmedetomidine sublingual film (BXCL501)BTDFast Track | BioXcel Therapeutics, Inc. | Phase 3 | Active | alpha-2A adrenoceptor Agonist |
| ITI-1284 (deulumateperone) | Johnson & Johnson | Phase 2 | Recruiting | 5-HT2A Antagonist |
| NMRA-511 | Neumora Therapeutics, Inc. | Phase 1 | Active | V1a receptor Antagonist |
| AVP-786 (deudextromethorphan-quinidine)FDA Fast Track (Agitation Associated With Dementia Of The Alzheimer'S Type; November 2015) | Otsuka Pharmaceutical Co., Ltd. | Discontinued | Discontinued | NMDA receptor Antagonist |
Trials recruiting now (1)
1 drug-interventional agitation in alzheimer's disease trial recruiting now, of 16 registered interventional trials. Browse all on ClinicalTrials.gov →
ITI-1284, Placebo
Frequently asked
- How many drugs are in development for agitation in alzheimer's disease?
- 5 compounds from 5 companies are in active clinical development for agitation in alzheimer's disease, including 2 at Phase 3 or beyond.
- Which agitation in alzheimer's disease drugs are in Phase 3?
- Phase 3 (or later) programs for agitation in alzheimer's disease include AXS-05 (dextromethorphan-bupropion) and Dexmedetomidine sublingual film (BXCL501).
- What are the next agitation in alzheimer's disease trial readouts?
- Upcoming catalysts include NMRA-511 (2H 2026), NMRA-511 (Q1 2027), ITI-1284 (deulumateperone) (Q4 2027) and Dexmedetomidine sublingual film (BXCL501) (Date TBD).
- How many clinical trials are recruiting for agitation in alzheimer's disease?
- 1 drug-interventional agitation in alzheimer's disease trial is currently recruiting participants, out of 16 registered interventional trials.