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ACADIA Pharmaceuticals, Inc.

ACADIA Pharmaceuticals, Inc. logo
🇺🇸United States
Ownership
Public
Established
1993-07-16
Employees
598
Market Cap
$2.6B
Website
http://www.acadia.com

Clinical Trials

102

Active:60
Completed:26

Trial Phases

5 Phases

Phase 1:59
Phase 2:18
Phase 3:19
+2 more phases

Drug Approvals

4

FDA:2
CANADA:1

Drug Approvals

NUPLAZID

Approval Date
Sep 19, 2023
FDA

Daybue

Approval Date
Mar 29, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (98 trials with phase data)• Click on a phase to view related trials

Phase 1
59 (60.2%)
Phase 3
19 (19.4%)
Phase 2
18 (18.4%)
Not Applicable
1 (1.0%)
Phase 4
1 (1.0%)

Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis

Not Applicable
Not yet recruiting
Conditions
Lewy Body Dementia Psychosis
Interventions
First Posted Date
2025-07-31
Last Posted Date
2025-07-31
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
126
Registration Number
NCT07095465

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

Phase 2
Recruiting
Conditions
Lewy Body Dementia Psychosis
Interventions
Drug: Placebo
First Posted Date
2025-06-19
Last Posted Date
2025-09-19
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
180
Registration Number
NCT07029581
Locations
🇺🇸

Humanity Clinical Research, Corp, Aventura, Florida, United States

🇺🇸

K2 Medical Research Winter Garden LLC, Clermont, Florida, United States

🇺🇸

K2 Summit Research, Lady Lake, Florida, United States

and more 5 locations

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Phase 3
Conditions
Hyperphagia in Prader-Willi Syndrome
Interventions
First Posted Date
2024-05-20
Last Posted Date
2025-09-05
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
160
Registration Number
NCT06420297
Locations
🇺🇸

Children's of Alabama, Birmingham, Alabama, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

University of California Irvine, Orange, California, United States

and more 27 locations

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study

Phase 3
Conditions
Alzheimer's Disease Psychosis
Interventions
First Posted Date
2024-01-08
Last Posted Date
2025-09-08
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
752
Registration Number
NCT06194799
Locations
🇧🇷

BR Trials-Ensaios Clinicos e Consultoria, São Paulo, Brazil

🇺🇸

ATP Clinical Research, Costa Mesa, California, United States

🇺🇸

National Institute Of Clinical Research, Garden Grove, California, United States

and more 48 locations

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Phase 3
Active, not recruiting
Conditions
Hyperphagia in Prader-Willi Syndrome
Interventions
Drug: Placebo
First Posted Date
2023-12-15
Last Posted Date
2025-09-10
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
170
Registration Number
NCT06173531
Locations
🇺🇸

Children's of Alabama, Birmingham, Alabama, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

University of California Irvine, Orange, California, United States

and more 27 locations
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News

Real-World LOTUS Study Shows Sustained Efficacy of DAYBUE in Rett Syndrome Patients Over 12 Months

Acadia Pharmaceuticals published interim results from the LOTUS study showing 71-90% of Rett syndrome patients experienced behavioral improvements with DAYBUE treatment over 12 months.

Major Pharmaceutical Companies Face Surge in Generic Drug Patent Challenges in Early 2025

Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025.

Acadia Pharmaceuticals Unveils $12 Billion Pipeline Strategy at Inaugural R&D Day

Acadia Pharmaceuticals outlined an ambitious multi-year strategy with a pipeline potentially generating up to $12 billion in annual peak sales across eight clinical programs.

Saniona Advances Neurological Pipeline with Strategic Partnerships and Strong Financial Position

Saniona secured SEK 115 million through warrant exercise and maintains SEK 261 million in cash, strengthening its financial runway to advance three internal neurological programs to Phase 2 trials.

Acadia Pharmaceuticals Appoints Bristol Myers Squibb Veteran to Lead Rare Disease Commercial Strategy

Acadia Pharmaceuticals has appointed Allyson McMillan-Youngblood as Senior Vice President, Rare Disease Franchise, bringing over 20 years of pharmaceutical industry experience.

Acadia Pharmaceuticals Secures Patent Victory for Parkinson's Drug Nuplazid Until 2038

The U.S. District Court for the District of Delaware ruled in favor of Acadia Pharmaceuticals, upholding their '721 formulation patent for Nuplazid against Aurobindo Pharma's generic challenge.

Acadia Pharmaceuticals Wins Patent Infringement Case Against Aurobindo for Parkinson's Drug Nuplazid

A U.S. District Court ruled that Aurobindo Pharma infringes on two key patent claims held by Acadia Pharmaceuticals for its Parkinson's disease drug Nuplazid.

FDA Approves Trofinetide as First-Ever Treatment for Rett Syndrome, Opening New Era for Rare Genetic Disorder

The FDA has approved trofinetide (developed by ACADIA Pharmaceuticals) as the first-ever treatment for Rett syndrome, a rare genetic disorder primarily affecting females that causes severe developmental delays and neurological symptoms.

FDA Priority Review Vouchers Face Transparency Challenges Amid Rising Prices

Priority Review Vouchers (PRVs) have surged in value to $150-158 million in recent months, up from the typical $100 million, following Congress's failure to reauthorize the rare pediatric disease program.

ACP-711 Shows Promising Safety Profile in Phase 1 Multiple-Ascending-Dose Study for Essential Tremor

Acadia Pharmaceuticals and Saniona successfully completed Phase 1 multiple-ascending-dose study of ACP-711 in healthy volunteers, demonstrating favorable safety and tolerability profile.

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