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 10 registered interventional trials.

Neurocognitive Disorders

Agitation in Alzheimer's disease drug pipeline

MeSH D011595
Subtype of Alzheimer's disease

4 compounds from 4 companies are in active clinical development for agitation in alzheimer's disease, including 2 at Phase 3 or beyond.

4Compounds

4Companies

2Phase 3+

4Upcoming readouts

1Trials recruiting

Approved 1
Phase 3 1
Phase 2 1
Phase 1 1

Mechanisms: Small molecule (4)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2H 2026AnticipatedNMRA-511Interim analysis
Anticipated readout from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511, expected in 2H 2026. ↗
Q1 2027AnticipatedNMRA-511Registry results
Anticipated initiation of a Phase 2 study of NMRA-511 in Alzheimer's disease agitation, planned for Q1 2027. ↗
Q4 2027AnticipatedITI-1284 (deulumateperone)Topline dataNCT06651567
Anticipated Phase 2 topline for ITI-1284 in agitation associated with Alzheimer's dementia (NCT06651567); primary completion targeted October 2027. ↗
Date TBDAnticipatedDexmedetomidine sublingual film (BXCL501)Topline data
Confirmatory TRANQUILITY In-Care Phase 3 (~150 patients, 60 mcg PRN, care setting) planned but not yet started as of Q1 2026. ↗
2026-04-30ReportedAXS-05 (dextromethorphan-bupropion)Regulatorymet
FDA approves AUVELITY (AXS-05) for agitation associated with dementia due to Alzheimer's disease — first non-antipsychotic approved ↗
2026-01-05ReportedNMRA-511Topline datametNCT06546995
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. ↗
2025-04-08ReportedAXS-05 (dextromethorphan-bupropion)Topline datametNCT04947553
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 ↗
2023-06-29ReportedDexmedetomidine sublingual film (BXCL501)Topline datametNCT05271552
TRANQUILITY II Phase 3 met its primary endpoint: 60 mcg sublingual dexmedetomidine cut PEC by 7.5 points at 2h vs 5.4 placebo (p=0.0112). ↗

See the full catalyst calendar →

Compounds in development (4)

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

Trials recruiting now (1)

1 drug-interventional agitation in alzheimer's disease trial recruiting now, of 10 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 2A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia
ITI-1284, Placebo
Intra-Cellular Therapies, Inc.n=320Bulgaria, Croatia +6 · 69 sitesStarted Oct 2024Tracked: ITI-1284 (deulumateperone)NCT06651567

Frequently asked

How many drugs are in development for agitation in alzheimer's disease?: 4 compounds from 4 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 10 registered interventional trials.