remlifanserin (ACP-204) / Acadia Pharma - LARVOL DELTA

Acadia Pharmaceuticals Announces Phase 3 Enabling Topline Results from Phase 2 RADIANT Study of Remlifanserin for the Treatment of Alzheimer’s Disease Psychosis (ADP) (Yahoo Finance) - "Detailed results to be presented at upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference in November...For the primary endpoint of change from baseline in the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D), once daily 60 mg remlifanserin demonstrated a change of -12.6 versus a -10.4 change for placebo at week 6, yielding a standardized effect size of 0.26 (p=0.0603). For the key secondary endpoint, Clinical Global Impression – Severity (CGI-S-ADP), the 60 mg dose achieved a change from baseline of -1.3 versus a change of -0.9 for placebo at week 6, yielding a standardized effect size of 0.37 [p=0.0077 (nominal)]....Given these data, Acadia plans to continue enrolling its two ongoing Phase 3 studies evaluating remlifanserin in ADP while implementing amendments to the Phase 3 program, including removing the 30 mg dosage arm."

P2 data • Trial status • Alzheimer's Disease • Psychiatry

An Open-Label Study Investigating the 5-HT2A Receptor Occupancy of Remlifanserin (ACP-204) With the PET Radioligand [18F]Altanserin in Healthy Male Participants. (PubMed, Clin Pharmacol Drug Dev) - "Remlifanserin (ACP-204) is a selective 5-HT2A receptor inverse agonist that builds upon scientific findings of its structural analog, pimavanserin. Single doses of remlifanserin were safe and well tolerated. Study findings will inform the development and dosing of remlifanserin in future Phase 2/3 trials."

Journal

Efficacy and Safety of Remlifanserin in Patients With Alzheimer's Disease Psychosis (CTAD 2026) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders • Psychiatry

Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease Psychosis (Yahoo Finance) - "Acadia is also providing an update on RADIANT, its development program evaluating remlifanserin for the treatment of hallucinations and delusions associated with ADP. Enrollment in the Phase 2 portion of the program has been completed, and the Company now expects to report topline results in September to October 2026. Consistent with RADIANT's operationally seamless design, screening and enrollment are underway in the Phase 3 studies."

Enrollment status • Fast track • P2 data • Alzheimer's Disease • Psychiatry

Nonclinical characterization of ACP-204, a novel selective serotonin receptor subtype 2A receptor inverse agonist. (PubMed, J Pharmacol Exp Ther) - "Pimavanserin was the first US Food and Drug Administration approved antipsychotic drug that does not block D2 dopamine receptors at therapeutic doses. ACP-204 is a novel 5-HT2A receptor inverse agonist/antagonist being evaluated clinically for its potential to treat Alzheimer disease psychosis and Lewy body dementia psychosis. Comprehensive nonclinical evaluations shown herein demonstrate that ACP-204 has optimized pharmacodynamic properties resulting in a favorable safety/tolerability profile, a broad therapeutic index, and promising effectiveness."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia • DRD2 • NAV1

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

Trial initiation date • 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 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc.

Trial initiation date • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Psychiatry

Population pharmacokinetics of remlifanserin (ACP-204), a serotonin 2A receptor inverse agonist. (PubMed, Alzheimers Dement (N Y)) - "The pharmacokinetics of oral remlifanserin (10 to 180 mg) are well described by dose-proportional linear kinetics. No intrinsic or extrinsic factors exhibited a clinically relevant effect on steady-state remlifanserin exposures."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Psychiatry

ACP-204-013: ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP) (clinicaltrialsregister.eu) - P2/3 | N=49 | Not yet recruiting | Sponsor: Acadia Pharmaceuticals Inc.

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

ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP) (clinicaltrialsregister.eu) - P1/2 | N=77 | Recruiting | Sponsor: Acadia Pharmaceuticals Inc.

New P1/2 trial • 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 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc. | Not yet recruiting ➔ Enrolling by invitation | Initiation date: Aug 2025 ➔ Dec 2025

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

Drug Development. (PubMed, Alzheimers Dement) - "The PK profiles were qualitatively similar over the studied dose ranges in healthy elderly and adult participants with minimal difference in exposure parameters 14% and 20% for Cmax,ss and AUC τ, respectively. ACP-204 was generally safe and well tolerated across age groups, with no unexpected safety findings."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Geriatric Disorders • Psychiatry

Drug Development. (PubMed, Alzheimers Dement) - "The criterion for bioequivalence for fed vs fasted was within the bioequivalence boundary for Cmax and AUC, indicating that food has no meaningful effect on the rate or extent of ACP-204 absorption. A single 60-mg dose of ACP-204 was safe and generally well tolerated, with no unexpected safety findings."

Clinical • Journal

Drug Development. (PubMed, Alzheimers Dement) - P2/3 | "Biomarkers, rather than syndromic presentation, are recommended as a mechanism by which to define AD biologically. Since biomarker data from patients presenting with clinical symptoms consistent with Alzheimer's disease dementia and psychosis are sparse, we present biomarker data in a rigorously phenotyped population. These results can also inform the design and execution of clinical trials in ADP in the future."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Psychiatry • APOE • Aβ42

Drug Development. (PubMed, Alzheimers Dement) - "No meaningful increases in QTcF were observed in healthy participants after single-dose administration of ACP-204 (10-180 mg); specifically, there was no QTcF prolongation up to 180 mg."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Psychiatry

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