Thioridazine

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 Thioridazine was withdrawn worldwide in 2005 due to its association with cardiac arrythmias.

Indication

For the treatment of schizophrenia and generalized anxiety disorder.

Associated Conditions

Psychosis
Schizophrenia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)	2015/11/09	NCT02600741	N/A	Completed	Janssen Scientific Affairs, LLC
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients	2014/12/04	NCT02307396	Phase 4	Completed	Technical University of Munich
Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia	2014/03/26	NCT02096289	Phase 1	Completed	Ontario Clinical Oncology Group (OCOG)
Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells	2013/01/10	NCT01765803	Early Phase 1	Terminated	New Mexico Cancer Care Alliance

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Thioridazine Hydrochloride	Mylan Pharmaceuticals Inc.	0378-0614	ORAL	25 mg in 1 1	11/28/2016
Thioridazine Hydrochloride	Mylan Institutional Inc.	51079-566	ORAL	25 mg in 1 1	12/16/2021
Thioridazine Hydrochloride	Mylan Institutional Inc.	51079-565	ORAL	10 mg in 1 1	12/16/2021
Thioridazine Hydrochloride	Mylan Institutional Inc.	51079-567	ORAL	50 mg in 1 1	12/16/2021
Thioridazine Hydrochloride	Mylan Institutional Inc.	51079-580	ORAL	100 mg in 1 1	12/16/2021
Thioridazine Hydrochloride	Mylan Pharmaceuticals Inc.	0378-0612	ORAL	10 mg in 1 1	11/28/2016
Thioridazine Hydrochloride	Mylan Pharmaceuticals Inc.	0378-0616	ORAL	50 mg in 1 1	11/28/2016
Thioridazine Hydrochloride	Sun Pharmaceutical Industries, Inc.	53489-148	ORAL	10 mg in 1 1	10/20/2017
Thioridazine Hydrochloride	Sun Pharmaceutical Industries, Inc.	53489-150	ORAL	50 mg in 1 1	10/20/2017
Thioridazine Hydrochloride	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
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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MELLARIL TAB 200MG	Sandoz Canada Inc	00027561	Tablet - Oral	200 MG / TAB	12/31/1959
MELLARIL TAB 100MG	Sandoz Canada Inc	00027553	Tablet - Oral	100 MG / TAB	12/31/1959
PMS-THIORIDAZINE 10MG/TAB USP	Pharmascience Inc	00575119	Tablet - Oral	10 MG	12/31/1984
NOVO-RIDAZINE 50MG	novopharm limited	00037486	Tablet - Oral	50 MG	12/31/1972
PMS-THIORIDAZINE SOLUTION 5MG/ML	Pharmascience Inc	00776513	Solution - Oral	5 MG / ML	12/31/1988
PMS-THIORIDAZINE SOLUTION 30MG/ML	Pharmascience Inc	00775320	Solution - Oral	30 MG / ML	12/31/1988
NOVO-RIDAZINE 10MG	novopharm limited	00037508	Tablet - Oral	10 MG	12/31/1972
MELLARIL TAB 25MG	Sandoz Canada Inc	00027537	Tablet - Oral	25 MG / TAB	12/31/1959
MELLARIL	novartis pharmaceuticals canada inc	00027375	Suspension - Oral	10 MG / 5 ML	12/31/1964
MELLARIL TAB 50MG	Sandoz Canada Inc	00027545	Tablet - Oral	50 MG / TAB	12/31/1959

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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