Drugs / Pimavanserin
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | NUPLAZID | — | 2018-06-28 – 2026-04-27 | fda.gov ↗ |
| Approved | US (FDA) | NUPLAZID | — | 2016-04-29 | fda.gov ↗ |
Trials 38 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05796167 | Jan 2023 → Jun 2024 | Parkinson disease | State University of New York - Downstate Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT04794413 | Nov 2018 → Feb 2021 | Tourette syndrome, tardive dyskinesia | Joseph Jankovic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07610135 | Jul 2026 → Jun 2028 expected | — | Johns Hopkins University | Not yet recruiting | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT05999240 | Oct 2025 → Dec 2026 expected | autism spectrum disorder | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03994965 | Dec 2024 | schizophrenia | Bjorn H. Ebdrup | Withdrawn | No outcome recorded |
| Phase 2 | NCT06455293 | Aug 2024 → Jun 2027 expected | Parkinson disease, depressive disorder | Joshua Woolley, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05895513 | Aug 2024 → Jan 2027 expected | intermittent explosive disorder | Ohio State University | Recruiting | No outcome recorded |
| Phase 2 | NCT03947216 | Oct 2020 → Apr 2024 | Parkinson disease | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase 2 | NCT04164758 | Oct 2019 → Sep 2020 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03482882 | Mar 2018 → Jul 2019 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03118947 | Feb 2017 → Feb 2019 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03018340 | Dec 2016 → Sep 2018 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02970305 | Nov 2016 → Oct 2019 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02992132 | Nov 2016 → Jan 2018 | — | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02035553 | Nov 2013 → Sep 2016 | Alzheimer disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00361166 | Aug 2005 → Mar 2007 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01518309 | Nov 2004 → May 2013 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00086294 | Jun 2004 → Nov 2007 | Parkinson disease, drug-induced dyskinesia | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00087542 | Mar 2004 → Dec 2005 | Parkinson disease, psychotic disorder | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05555615 | Nov 2022 → Feb 2025 | autism spectrum disorder | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT05523895 | Aug 2022 → Sep 2024 | autism spectrum disorder | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT06068465 | Sep 2024 → Feb 2026 | Parkinson disease | Tasly Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT04531982 | Aug 2020 → Jan 2024 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04000009 | Jun 2019 → Feb 2021 | — | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03968159 | Apr 2019 → Apr 2020 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03623321 | Jul 2018 → May 2023 | neurodegenerative disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03575052 | May 2018 → May 2022 | neurodegenerative disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03325556 | Sep 2017 → Jul 2019 | psychotic disorder | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03121586 | Jan 2017 → Apr 2024 | schizophrenia | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02970292 | Oct 2016 → May 2019 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01174004 | Jul 2010 → Nov 2012 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00550238 | Jul 2007 → May 2018 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00477672 | Jun 2007 → Jun 2009 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05357612 | Jan 2023 → Jun 2027 expected | Parkinson disease, neurodegenerative disease | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04809116 | Dec 2022 → Dec 2023 | insomnia, post-traumatic stress disorder | Baylor College of Medicine | Withdrawn | No outcome recorded |
| Phase 4 | NCT04292223 | Feb 2020 → Apr 2022 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04188392 | Jan 2020 → Oct 2021 | insomnia, post-traumatic stress disorder | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07022366 | Feb 2025 → Jun 2026 overdue | — | University of Oxford | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05350215 Comparator | Jun 2022 → Dec 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06592833 Comparator | Feb 2025 → Mar 2028 expected | major depressive disorder | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT05441280 Comparator | Dec 2023 → Jul 2027 expected | insomnia, post-traumatic stress disorder | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00658567 Comparator | Mar 2008 → Dec 2009 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04373317 Comparator | Oct 2022 → Oct 2026 expected | Parkinson disease | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT05590637 Comparator | Apr 2022 → Aug 2026 overdue | Lewy body dementia, Parkinson disease | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02762591 Background | — | Parkinson disease | ACADIA Pharmaceuticals Inc. | Approved for marketing | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pimavanserin | “Pimavanserin, a promising serotonin 2A receptor antagonist, may help to counteract atomoxetine's noradrenergic effects by increasing arousal threshold and possibly reducing OSA...” PMID 40158847 ↗ Mar 202540 |
| Known as | ACP-103 | “pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks” NCT00658567 ↗6“Pimavanserin tartrate (ACP-103)” NCT00477672 ↗ “pimavanserin tartrate (ACP-103)” NCT01518309 ↗ “Pimavanserin tartrate (ACP-103)” NCT00550238 ↗ |
| Known as | NUPLAZID | “Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions...” NCT03947216 ↗5“Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)” NCT03482882 ↗ “Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)” NCT03575052 ↗ “It is currently marketed under the name NUPLAZID (pimavanserin) capsules by Acadia Pharmaceuticals.” NCT04794413 ↗ “Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]” NCT05999240 ↗ “Drug: Pimavanserin 34 milligrams (MG) [Nuplazid]” NCT03994965 ↗ |
| Known as | pimavanserin tartrate | “Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)” NCT02035553 ↗7“Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth” NCT02992132 ↗ “pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks” NCT00658567 ↗ “Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]” NCT05999240 ↗ “Pimavanserin tartrate (ACP-103)” NCT00477672 ↗ “pimavanserin tartrate (ACP-103)” NCT01518309 ↗ “Pimavanserin tartrate (ACP-103)” NCT00550238 ↗ |
| Known as | Pimavanserina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111101 ↗ |
| Known as | Pimavanserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111101 ↗ |
| Action | Inhibit | “the effect of the 5HT2A/C receptor inverse agonist ACP-103” NCT00086294 ↗ |
| Modality | Small molecule | — CHEMBL2111101 ↗ |
| Route | Oral | “Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed...” NCT00086294 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor inverse agonist” CHEMBL2111101 ↗ |