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
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-â ¢ | 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 |