Drugs / Iloperidone
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed bipolar I disorder 1 milestone | |||||
| Filed | US (FDA) | Fanapt | bipolar I disorder | 2023-11-08 | “sNDA) for Fanapt ® in bipolar I disorder in adults was accepted for filing by the U.S. Food and Drug Administration (FDA)” vandapharma.com ↗ |
| Rejected schizophrenia 3 milestones | |||||
| Refused (EMA) | EU (EMA) | Fanaptum | schizophrenia | 2017-11-10 | “refusal of the marketing authorization application (MAA) of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia” vandapharma.com ↗ |
| Refused (EMA) | EU (EMA) | Fanaptum | schizophrenia | 2017-07-21 | “negative opinion recommending against the marketing authorization of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union” vandapharma.com ↗ |
| Refused (EMA) | EU (EMA) | Fanaptum | schizophrenia | 2012-12-13 | “negative opinion recommending against approval of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union” vandapharma.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| 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
| 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 Stop: Business |
| Phase 2 | NCT01917318 | Jul 2013 → Feb 2014 | post-traumatic stress disorder | University of Colorado, Denver | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01623713 | Jun 2012 → Oct 2013 | schizophrenia | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00254202 | Nov 2005 → Sep 2006 | schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT05648591 | May 2023 → Dec 2028 expected | 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 Stop: Enrollment |
| Phase 4 | NCT01464229 | Apr 2012 → Dec 2014 | major depressive disorder | Maurizio Fava, MD | Completed | Missed primary |
| Phase 4 | NCT01207414 | Aug 2010 → Jan 2012 | schizophrenia | Novartis | Completed | No outcome recorded |
| Comparator or background therapy4 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 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | Missed primary |
| Phase 4 | NCT00806234 Comparator | Jan 2009 → Mar 2014 | psychotic disorder | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-04-02 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals' Fanapt® (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt ® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. |
| 2022-12-19 | Vanda Pharmaceuticals | Results Fanapt® Shown to be Effective in Bipolar I Disorder in Phase III Clinical Study vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported positive results in a Phase III clinical study of Fanapt ® (iloperidone tablets), a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. |
| 2017-11-10 | Vanda Pharmaceuticals | Regulatory Vanda Receives Negative Opinion for Marketing Authorization from the European Medicines Agency on Fanaptum™ for the Treatment of Schizophrenia vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today the refusal of the marketing authorization application (MAA) of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union . |
| 2017-07-21 | Vanda Pharmaceuticals | Regulatory Vanda Receives Negative Opinion for Marketing Authorization from the European Medicines Agency on Fanaptum™ for the Treatment of Schizophrenia vandapharma.com ↗
The CHMP was of the opinion that the benefits of Fanaptum™ did not outweigh its risks and recommended against marketing authorization. |
| 2016-05-26 | Vanda Pharmaceuticals | Regulatory Vanda Announces FDA Approval of the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults vandapharma.com ↗ |
| 2015-12-22 | Vanda Pharmaceuticals | Regulatory European Medicines Agency Accepts Fanaptum® (iloperidone) Marketing Authorization Application for the Treatment of Schizophrenia in Adults vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that its Marketing Authorization Application (MAA) for oral Fanaptum ® tablets has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults. |
| 2015-06-23 | Vanda Pharmaceuticals | Results Vanda Announces Positive Results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) Demonstrating the Long-Term Maintenance Effects of Fanapt® (iloperidone) vandapharma.com ↗
The REPRIEVE study demonstrated the ability of Fanapt® (iloperidone) to prevent relapse or impending relapse in adult patients with schizophrenia as compared to placebo. |
| 2013-03-14 | Vanda Pharmaceuticals | Regulatory Vanda Withdraws Its Marketing Authorization Application For Fanaptum™ In The European Union vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today that it has withdrawn its Marketing Authorization Application (MAA) submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™ (oral iloperidone tablets) for the treatment of adult patients with schizophrenia. |
| 2012-12-13 | Vanda Pharmaceuticals | Regulatory Vanda Receives Negative Opinion from CHMP on Fanaptum™ for the Treatment of Schizophrenia vandapharma.com ↗
The CHMP was of the opinion that the benefits of Fanaptum™ did not outweigh its risks and recommended against marketing authorization at this point in time. |
All press releases naming this drug 35 releases
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 ↗ |