Overview
A phenothiazine antipsychotic used in the management of psychoses, including schizophrenia, and in the control of severely disturbed or agitated behavior. It has little antiemetic activity. Thioridazine has a higher incidence of antimuscarinic effects, but a lower incidence of extrapyramidal symptoms, than chlorpromazine. (From Martindale, The Extra Pharmacopoeia, 30th ed, p618). Thioridazine was withdrawn worldwide in 2005 due to its association with cardiac arrythmias.
Background
A phenothiazine antipsychotic used in the management of psychoses, including schizophrenia, and in the control of severely disturbed or agitated behavior. It has little antiemetic activity. Thioridazine has a higher incidence of antimuscarinic effects, but a lower incidence of extrapyramidal symptoms, than chlorpromazine. (From Martindale, The Extra Pharmacopoeia, 30th ed, p618). Thioridazine was withdrawn worldwide in 2005 due to its association with cardiac arrythmias.
Indication
For the treatment of schizophrenia and generalized anxiety disorder.
Associated Conditions
- Psychosis
- Schizophrenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/11/09 | N/A | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/12/04 | Phase 4 | Completed | Technical University of Munich | ||
2014/03/26 | Phase 1 | Completed | Ontario Clinical Oncology Group (OCOG) | ||
2013/01/10 | Early Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 0378-0614 | ORAL | 25 mg in 1 1 | 11/28/2016 | |
| Mylan Institutional Inc. | 51079-566 | ORAL | 25 mg in 1 1 | 12/16/2021 | |
| Mylan Institutional Inc. | 51079-565 | ORAL | 10 mg in 1 1 | 12/16/2021 | |
| Mylan Institutional Inc. | 51079-567 | ORAL | 50 mg in 1 1 | 12/16/2021 | |
| Mylan Institutional Inc. | 51079-580 | ORAL | 100 mg in 1 1 | 12/16/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-0612 | ORAL | 10 mg in 1 1 | 11/28/2016 | |
| Mylan Pharmaceuticals Inc. | 0378-0616 | ORAL | 50 mg in 1 1 | 11/28/2016 | |
| Sun Pharmaceutical Industries, Inc. | 53489-148 | ORAL | 10 mg in 1 1 | 10/20/2017 | |
| Sun Pharmaceutical Industries, Inc. | 53489-150 | ORAL | 50 mg in 1 1 | 10/20/2017 | |
| Sun Pharmaceutical Industries, Inc. | 53489-500 | ORAL | 100 mg in 1 1 | 10/20/2017 |
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 |
|---|---|---|---|---|---|
| Thioridazine Hydrochloride Tablets | 国药准字H10930125 | 化学药品 | 片剂 | 5/6/2020 | |
| Thioridazine Hydrochloride Tablets | 国药准字H10930126 | 化学药品 | 片剂 | 4/25/2020 |
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. | |||||