Drugs / Pimozide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ORAP | — | 1994-07-27 | fda.gov ↗ |
| Approved | US (FDA) | ORAP | — | 1984-07-31 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT03272503 | Oct 2017 → Dec 2020 | amyotrophic lateral sclerosis | University of Calgary | Unknown | No outcome recorded |
| Phase 2 | NCT02463825 | Apr 2015 → Aug 2016 | amyotrophic lateral sclerosis | University of Calgary | Unknown | No outcome recorded |
| Phase 2 | NCT00004652 | Feb 1993 → ? | Tourette syndrome | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01765829 | Nov 2012 → Nov 2015 | psychotic disorder | Fundación Pública Andaluza Progreso y Salud | Unknown | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT02307396 | Feb 2015 → Jun 2016 | schizoaffective disorder, schizophrenia | Technical University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT00158223 | Oct 2004 → Feb 2009 | schizophrenia | Icahn School of Medicine at Mount Sinai | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT05507372 | Oct 2022 → Jun 2023 | tinnitus | Applied Biology, Inc. | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT05716854 Comparator | Mar → Jun 2023 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 2 | NCT04529226 Comparator | Nov 2020 → Jan 2025 | intellectual disability, psychotic disorder | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 2 | NCT00374244 Comparator | Jan 2004 → Jun 2011 | schizophrenia | Yale University | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pimozide | “Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ |
| Known as | MCN-JR-6238 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1423 ↗ |
| Known as | NSC-170984 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1423 ↗ |
| Known as | Orap | “Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome” NCT00004652 ↗ |
| Known as | Pimozida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1423 ↗ |
| Known as | R 623 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1423 ↗ |
| Known as | R 6238 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1423 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1423 ↗1“dopamine receptor antagonist Pimozide” NCT05507372 ↗ |
| Modality | Small molecule | “Pimozide, a diphenylbutylpiperidine, possesses pharmacological and clinical properties distinct from other typical antipsychotics.” PMID 21346734 ↗ Feb 2011 |
| Route | Oral | “Patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month.” NCT00004652 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1423 ↗ |