Alzheimer's disease psychosis drug pipeline
- ICD-11 6E61
- Subtype of Alzheimer's disease
2 compounds from 2 companies are in active clinical development for alzheimer's disease psychosis, including 1 at Phase 3 or beyond.
- Phase 3 1
- Phase 2 1
Mechanisms: Small molecule (2)
Pipeline data compiled July 2026 · every fact sourced.
Upcoming readouts & recent results
Topline results from the Phase 2 RADIANT substudy of remlifanserin (ACP-204) 30 mg and 60 mg vs placebo in Alzheimer's disease psychosis (primary endpoint: change from baseline in SAPS-H+D at Week 6), expected September–October 2026. ↗
Topline results from the Phase 2 VISTA trial of ML-007C-MA 210/3 mg BID versus placebo in hallucinations and delusions associated with Alzheimer's disease psychosis — primary endpoint change from baseline in NPI-C H+D score at Week 7 — expected in the second half of 2027. ↗
ClinicalTrials.gov estimated primary completion of the full RADIANT master protocol (NCT06159673), which covers both Phase 3 confirmatory substudies: January 2028 (estimated study completion February 2028). ↗
Compounds in development (2)
| Compound | Company | Phase | Status | Mechanism |
|---|---|---|---|---|
| RemlifanserinFDA Fast Track (Alzheimer'S Disease Psychosis; Granted 2026-07-20) | ACADIA Pharmaceuticals Inc. | Phase 3 | Active | 5-HT2A Inverse agonist |
| ML-007C-MAFDA Fast Track (Hallucinations And Delusions Associated With Alzheimer'S Disease Psychosis; Granted December 2025, Announced 2026-01-05) | MapLight Therapeutics, Inc. | Phase 2 | Recruiting | M1 Agonist |
Trials recruiting now (4)
4 drug-interventional alzheimer's disease psychosis trials recruiting now, of 4 registered interventional trials. Browse all on ClinicalTrials.gov →
- Phase 3A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
ACP-204
ACP-204, Placebo
ML-007C-MA
ML-007C-MA, Placebo
Frequently asked
- How many drugs are in development for alzheimer's disease psychosis?
- 2 compounds from 2 companies are in active clinical development for alzheimer's disease psychosis, including 1 at Phase 3 or beyond.
- Which alzheimer's disease psychosis drugs are in Phase 3?
- Phase 3 (or later) programs for alzheimer's disease psychosis include Remlifanserin.
- What are the next alzheimer's disease psychosis trial readouts?
- Upcoming catalysts include Remlifanserin (September to October 2026), ML-007C-MA (2H 2027) and Remlifanserin (January 2028).
- How many clinical trials are recruiting for alzheimer's disease psychosis?
- 4 drug-interventional alzheimer's disease psychosis trials are currently recruiting participants, out of 4 registered interventional trials.