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ACP-211

Phase 2

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |ACADIA Pharmaceuticals Inc.|Trials Updated: Oct 5, 2026

ACP-211 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2025

ACP-211 target and mechanism

Molecular targetNMDA
ModalitySmall molecule

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

ACP-211 clinical trials

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 Sites28

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)

LOWOct 5, 2026NCT07284667lastUpdatePostDate: changed
LOWOct 5, 2026NCT07284667lastUpdatePostDate: changed
LOWSep 15, 2026NCT07284667lastUpdatePostDate: changed
LOWSep 15, 2026NCT07284667lastUpdatePostDate: changed
LOWSep 15, 2026NCT07284667lastUpdatePostDate: changed
LOWAug 6, 2026NCT07284667lastUpdatePostDate: changed
LOWAug 6, 2026NCT07284667lastUpdatePostDate: changed

Frequently asked questions about ACP-211

What is ACP-211 used for?

ACP-211 is an investigational small molecule being developed for Major Depressive Disorder (MDD). It is currently being studied as a monotherapy in patients with MDD who have had an inadequate response to prior antidepressant treatment. The drug is in Phase 2 clinical development and has not been approved by regulatory authorities.

What does ACP-211 target?

ACP-211 targets the NMDA receptor, a molecular target involved in the pathophysiology of depression. By modulating NMDA receptor activity, the drug is being investigated for its potential to treat Major Depressive Disorder. This mechanism is being evaluated in a Phase 2 clinical trial for patients with inadequate antidepressant response.

Who makes ACP-211?

ACP-211 is being developed by ACADIA Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACAD. The company is currently conducting a Phase 2 clinical trial to evaluate the drug as a monotherapy for Major Depressive Disorder in patients who have not responded adequately to existing antidepressants.

What phase is ACP-211 in?

ACP-211 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is recruiting participants to evaluate the drug's efficacy and safety as a monotherapy for Major Depressive Disorder with inadequate antidepressant response.

What clinical trials is ACP-211 in?

ACP-211 is being evaluated in one Phase 2 clinical trial with the identifier NCT07284667. This randomized, double-blind, placebo-controlled study is recruiting 153 participants in the United States. The trial is investigating ACP-211 monotherapy for Major Depressive Disorder in adults aged 18 years and older who have had an inadequate response to antidepressants.