Overview
Iloperidone is an atypical antipsychotic for the treatment of schizophrenia symptoms. Hoechst Marion Roussel Inc. researched the drug until May 1996. In June 1997 they gave the research rights to Titan Pharmaceuticals, who gave the worldwide development, manufacturing, and marketing rights to Novartis in August 1998. On June 9, 2004, Titan Pharmaceuticals gave the Phase III development rights to Vanda Pharmaceuticals. FDA approved on May 9, 2009.
Indication
Treatment of acute schizophrenia.
Associated Conditions
- Schizophrenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/08 | Phase 3 | Not yet recruiting | |||
2024/07/10 | Phase 1 | Not yet recruiting | |||
2022/12/13 | Phase 4 | Recruiting | |||
2022/04/25 | Phase 2 | Withdrawn | |||
2021/07/20 | Phase 1 | Completed | |||
2021/03/29 | Phase 3 | Completed | |||
2021/01/15 | Phase 1 | Completed | |||
2019/10/15 | Phase 1 | Completed | |||
2018/02/05 | Phase 1 | UNKNOWN | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2015/11/09 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Avera McKennan Hospital | 69189-0665 | ORAL | 4 mg in 1 1 | 3/28/2017 | |
| Vanda Pharmaceuticals Inc. | 43068-108 | ORAL | 8 mg in 1 1 | 9/15/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-0634 | ORAL | 8 mg in 1 1 | 12/21/2022 | |
| Vanda Pharmaceuticals Inc. | 43068-112 | ORAL | 12 mg in 1 1 | 9/15/2021 | |
| Vanda Pharmaceuticals Inc. | 43068-905 | ORAL | 1 mg in 1 1 | 5/12/2025 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4181 | ORAL | 6 mg in 1 1 | 3/29/2018 | |
| Vanda Pharmaceuticals Inc. | 43068-102 | ORAL | 2 mg in 1 1 | 9/15/2021 | |
| Vanda Pharmaceuticals Inc. | 43068-902 | ORAL | 8 mg in 1 1 | 9/15/2021 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4182 | ORAL | 8 mg in 1 1 | 3/29/2018 | |
| Vanda Pharmaceuticals Inc. | 43068-110 | ORAL | 10 mg in 1 1 | 9/15/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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