ACP-204 / Acadia Pharma - LARVOL DELTA

Design of the Phase 2, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of ACP-204, a Novel 5-HT2A Inverse Agonist, in Adults With Lewy Body Dementia Psychosis (MDS Congress 2025) - "ACP-204 is a selective 5-HT2A (less so at 5-HT2C) inverse agonist/antagonist discovered to have an improved pharmacological profile compared with pimavanserin, which is approved for PDP. This will be the first clinical study to evaluate the efficacy and safety of ACP-204 in patients with LBDP, a population with considerable unmet needs. Abstract Figure"

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry

Acadia Pharmaceuticals Inc...announced one late-breaker oral platform presentation and two poster presentations to be presented at the International Congress of Parkinson’s Disease and Movement Disorders being held October 5-9, 2025, in Honolulu, Hawaii. (Yahoo Finance) - "The presentations highlight updates from the company’s robust pipeline including preclinical efficacy, safety and mechanism of action findings on Acadia’s investigational drug ACP-711, under development for essential tremor, as well as a report on the study design of the Phase 2 ACP-204 study in adults with Lewy body dementia psychosis. The company will also present encore findings from a post-hoc analysis of clinical trial data evaluating duration of illness and response to NUPLAZID (pimavanserin) in Parkinson’s disease psychosis."

Clinical protocol • Preclinical • Retrospective data • Dementia • Essential Tremor • Lewy Body Disease • Parkinson's Disease

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: ACADIA Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Psychiatry

Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis (clinicaltrials.gov) - P3 | N=126 | Not yet recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P3 trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Psychiatry

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Psychiatry

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Initiation of a Phase 2 study of ACP-204 for a second indication in Lewy Body Dementia in the third quarter of 2025; The Company will host its first ever R&D Day in mid-2025; Annual net sales for the full-year 2025 expected to exceed $1 billion for the first time in Company history."

New P2 trial • Sales projection • Dementia

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Key 2025-2026 Milestones...Initiation of Managed Access Programs in Europe in the second quarter of 2025, potentially resulting in the Company’s first revenues from outside the U.S; Enrollment of the last patient in the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome anticipated in the fourth quarter of 2025, followed by top-line results announcement in the first half of 2026; Enrollment of the last patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis expected in the first quarter of 2026, followed by top-line results announcement in mid-2026."

Commercial • Enrollment status • P2 data • P3 data: top line • Alzheimer's Disease • CNS Disorders • Prader–Willi syndrome

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study (clinicaltrials.gov) - P3 | N=752 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Alzheimer's Disease • CNS Disorders • Psychiatry

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study (clinicaltrials.gov) - P3 | N=752 | Not yet recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P3 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

ACP-204 in Adults With Alzheimer's Disease Psychosis (clinicaltrials.gov) - P2/3 | N=1074 | Recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P2/3 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ACP-204 for the Treatment of Alzheimer’s Disease Psychosis (Businesswire) - "Acadia Pharmaceuticals Inc...today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP)....The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes three studies: a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from Baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales (SAPS-H+D) total score at Week 6."

New P2a trial • Alzheimer's Disease • CNS Disorders • Psychiatry