Drugs / Iloperidone
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Iloperidone Vanda Pharmaceuticals | — | 2026-06-12 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | FANAPT | — | 2016-05-26 – 2024-04-02 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Fanaptum | — | 2018-01-15 | europa.eu ↗ |
| Approved | US (FDA) | FANAPT | — | 2009-05-06 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06494397 | Jul → Oct 2024 | bipolar I disorder, schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04712734 | Jan 2021 → Aug 2022 | schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04127058 | Oct → Nov 2019 | bipolar I disorder, schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01495169 | Oct 2011 → Feb 2015 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01529294 | Aug 2010 → Jul 2012 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01348100 | Apr 2011 → Jul 2012 | schizophrenia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07090161 | Sep 2025 → Oct 2026 expected | hypertensive disorder | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05344365 | Jun 2022 → Nov 2023 | Parkinson disease | Vanda Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT01917318 | Jul 2013 → Feb 2014 | post-traumatic stress disorder | University of Colorado, Denver | Terminated | No outcome recorded |
| Phase 2 | NCT01623713 | Jun 2012 → Oct 2013 | schizophrenia | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06961968 | May 2025 → Nov 2027 expected | schizophrenia | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT04819776 | Mar 2021 → Sep 2022 | bipolar I disorder | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02453893 | Nov 2013 → Jun 2015 | schizophrenia | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01291511 | Feb 2011 → Mar 2014 | schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00254202 | Nov 2005 → Sep 2006 | schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05648591 | May 2023 → Mar 2026 overdue | bipolar I disorder, schizophrenia | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT01920802 | Nov 2012 → Aug 2014 | — | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT02413918 | Apr 2012 → Apr 2015 | bipolar disorder | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT01929889 | Apr 2012 → Feb 2014 | schizoaffective disorder, schizophrenia | Northwestern University | Terminated | No outcome recorded |
| Phase 4 | NCT01464229 | Apr 2012 → Dec 2014 | major depressive disorder | Maurizio Fava, MD | Completed | No outcome recorded |
| Phase 4 | NCT01207414 | Aug 2010 → Jan 2012 | schizophrenia | Novartis | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03565068 Background | Jun 2018 → Apr 2020 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02181803 Background | Aug 2014 → Apr 2015 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00806234 Comparator | Jan 2009 → Mar 2014 | psychotic disorder | Johns Hopkins University | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iloperidone | “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗24“Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.” NCT03319953 ↗ “AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone” NCT03565068 ↗ |
| Known as | Fanapt | ChEMBL registry synonym — accepted as the source's own label CHEMBL14376 ↗ |
| Known as | HP 873 | ChEMBL registry synonym — accepted as the source's own label CHEMBL14376 ↗ |
| Known as | Iloperidona | ChEMBL registry synonym — accepted as the source's own label CHEMBL14376 ↗ |
| Action | Inhibit | “a new antipsychotic with mixed dopamine and serotonin antagonism” NCT01929889 ↗2“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL14376 ↗ “Dopamine D2 receptor antagonist” CHEMBL14376 ↗ |
| Modality | Small molecule | — CHEMBL14376 ↗ |
| Route | Oral | “Oral iloperidone” NCT00254202 ↗ |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL14376 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL14376 ↗ |