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ACP-211

Phase 2

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |ACADIA Pharmaceuticals Inc.|Last Updated: Aug 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

ACP-211 · 1 trial · 2 indications

Phase 2 1
NCT07284667ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant ResponseMajor Depressive Disorder (MDD)
RECRUITING153 Analytics
PHASE2RECRUITING
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
Baseline and Day 28

The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.

Secondary Endpoints

Change From Baseline in MADRS Total Score at Day 2
Baseline and Day 2 (24 hours postdose)
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
Baseline through Day 28
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits
Baseline through Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ACP-211 600 mgEXPERIMENTALACP-211 600 mg, administered orally twice weekly
ACP-211 300 mgEXPERIMENTALACP-211 300 mg, administered orally twice weekly
PlaceboPLACEBO_COMPARATORMatching placebo, administered orally twice weekly

Interventions

NameTypeDescription
ACP-211DRUGACP-211 monotherapy
PlaceboDRUGPlacebo control
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Adults ≥18 and ≤65 years of age * Provides written informed consent * Clinical diagnosis of MDD * History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode * Currently treated with an approved an...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 6, 2026NCT07284667lastUpdatePostDate: changed
LOWAug 6, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 13, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 13, 2026NCT07284667lastUpdatePostDate: changed

Frequently asked questions about ACP-211

What is ACP-211 used for?

ACP-211 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and is being studied in patients with MDD who have had an inadequate response to prior antidepressant therapy.

Who makes ACP-211?

ACP-211 is being developed by ACADIA Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACAD. The company is conducting a Phase 2 clinical trial of ACP-211 in the United States.

What phase is ACP-211 in?

ACP-211 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 trial is actively recruiting participants to evaluate its safety and efficacy in patients with Major Depressive Disorder.

What clinical trials is ACP-211 in?

ACP-211 is being studied in a Phase 2 clinical trial with the identifier NCT07284667. This randomized, double-blind, placebo-controlled trial is evaluating ACP-211 as a monotherapy for Major Depressive Disorder with inadequate antidepressant response. The trial is recruiting 153 participants in the United States.

How does ACP-211 work?

ACP-211 is a small molecule being developed for Major Depressive Disorder. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.