Ozmosi | Pimavanserin Drug Profile
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Pimavanserin

Alternative Names: pimavanserin, acp-103, nuplazid
Clinical Status: Active
Latest Update: 2026-01-13
Latest Update Note: News Article

Product Description

Pimavanserin (ACP-103) is a selective inverse agonist of the 5-hydroxytryptamine 2A (5-HT2A) receptor intended to treat patients with Parkinson's disease psychosis (PDP). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/26744739/)

Mechanisms of Action: 5-HT2A Inverse Agonist, 5-HT2A Antagonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Bangladesh | United States

Approved Indications: None

Known Adverse Events: None

Company: Acadia
Company Location: Western America
Company CEO: Stephen R. Davis
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Pimavanserin

Countries in Clinic: Argentina, Australia, Bulgaria, China, Colombia, Croatia, Czech Republic, France, Georgia, Hungary, India, Italy, Lithuania, Mexico, Poland, Romania, Russia, Serbia, South Africa, Spain, Ukraine, United States

Active Clinical Trial Count: 12

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Acadia presented P3 Schizophrenia results on 2024-03-11 for Pimavanserin
  • PDUFA Summary: FDA accepted Acadia's supplemental new drug application for pimavanserin on June 3, 2020, with a target action date of April 3, 2021.

Highest Development Phases

Phase 3: Autism Spectrum Disorder|Other|Parkinson's Disease|Psychotic Disorders|Schizophrenia

Phase 2: Conduct Disorder

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05999240

NCT05999240

P2

Recruiting

Autism Spectrum Disorder

2026-05-15

12%

2025-03-07

NCT05895513

2023H0014

P2

Recruiting

Conduct Disorder

2027-01-01

12%

2025-03-28

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT06068465

TSL-CM-JSSPMFSL-Ⅲ

P3

Recruiting

Parkinson's Disease|Schizophrenia|Psychotic Disorders

2025-10-01

25%

2025-08-20

Primary Completion Date|Primary Endpoints|Treatments

NCT03623321

ACP-103-047

P3

Completed

Other

2023-05-05

18%

2025-08-27

Primary Endpoints

NCT05523895

ACP-103-069

P3

Completed

Autism Spectrum Disorder

2024-09-27

18%

2025-08-26

Primary Endpoints|Treatments

2019-003343-29

ADVANCE 2

P3

Completed

Schizophrenia

2024-02-19

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT04531982

ADVANCE-2

P3

Completed

Schizophrenia

2024-01-25

16%

2025-04-02

NCT06450184

PR/BE/23/296

P1

Completed

Parkinson's Disease|Schizophrenia

2024-01-17

2024-10-16

Primary Endpoints|Treatments

2017-004439-36

2017-004439-36

P3

Active, not recruiting

Other

2022-05-19

18%

2022-03-13

Treatments

2024-512202-25-00

ACP-103-070

P2

Completed

Autism Spectrum Disorder

2025-02-09

2025-05-02

Treatments

NCT03947216

PIMPARK

P2

Completed

Conduct Disorder|Parkinson's Disease

2024-04-23

2025-01-03

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

2021-005387-22

2021-005387-22

P2

Active, not recruiting

Autism Spectrum Disorder

2024-04-04

2025-05-06

Treatments