Overview
Zuclopenthixol, also known as Zuclopentixol or Zuclopenthixolum, is an antipsychotic agent. Zuclopenthixol is a thioxanthene-based neuroleptic with therapeutic actions similar to the phenothiazine antipsychotics. It is an antagonist at D1 and D2 dopamine receptors. Major brands of zuclopenthixol are Cisordinol, Acuphase, and Clopixol. This drug is a liquid. This compound belongs to the thioxanthenes. These are organic polycyclic compounds containing a thioxanthene moiety, which is an aromatic tricycle derived from xanthene by replacing the oxygen atom with a sulfur atom. Known drug targets of zuclopenthixol include 5-hydroxytryptamine receptor 2A, D(1B) dopamine receptor, D(2) dopamine receptor, D(1A) dopamine receptor, and alpha-1A adrenergic receptor. It is known that zuclopenthixol is metabolized by Cytochrome P450 2D6. Zuclopenthixol was approved for use in Canada in 2011, but is not approved for use in the United States.
Indication
用于治疗有焦虑和幻觉症状的精神病、类妄想狂-幻觉型精神分裂症、青春期痴呆、躁狂及焦虑周期性精神病；精神因素引起的不安、兴奋、精神错乱，脑萎缩过程，外伤后的精神病、震颤谵妄等。本品较适用于老年患者。
Associated Conditions
- Acute Exacerbation of Psychosis
- Acute Schizophrenia
- Chronic Schizophrenia
- Organic Mental Disorder
- Schizophrenia
- Acute Manic episode
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2014/12/04 | Phase 4 | Completed | Technical University of Munich | ||
2008/10/07 | Phase 4 | Terminated | |||
2005/09/21 | Not Applicable | Completed | Birte Glenthoj |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| CLOPIXOL DEPOT INJECTION 200 mg/ml | SIN01365P | INJECTION | 200 mg/ml | 5/18/1988 |
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 |
|---|---|---|---|---|---|
| CLOPIXOL ACUPHASE zuclopenthixol acetate 100 mg/2 mL injection ampoule | 46061 | Medicine | A | 9/20/1993 | |
| CLOPIXOL DEPOT zuclopenthixol decanoate 200 mg/1 mL injection ampoule | 45082 | Medicine | A | 9/20/1993 | |
| CLOPIXOL zuclopenthixol 10 mg (as zuclopenthixol hydrochloride) tablet bottle | 45077 | Medicine | A | 9/20/1993 | |
| CLOPIXOL ACUPHASE zuclopenthixol acetate 50 mg/1 mL injection ampoule | 45080 | Medicine | A | 9/20/1993 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CLOPIXOL DEPOT - LIQ IM 500MG/ML | hoechst marion roussel canada inc. | 02162962 | Liquid - Intramuscular | 500 MG / ML | 12/31/1995 |
| CLOPIXOL-ACUPHASE 50MG/ML | 02230405 | Solution - Intramuscular | 50 MG / ML | 4/7/1997 | |
| CLOPIXOL DEPOT 200MG/ML | 02230406 | Solution - Intramuscular | 200 MG / ML | 4/7/1997 | |
| CLOPIXOL ACUPHASE - LIQ IM 50MG/ML | hoechst marion roussel canada inc. | 02162946 | Liquid - Intramuscular | 50 MG / ML | 12/31/1995 |
| CLOPIXOL DEPOT - LIQ IM 200MG/ML | hoechst marion roussel canada inc. | 02162954 | Liquid - Intramuscular | 200 MG / ML | 12/31/1995 |
| CLOPIXOL DEPOT 500MG/ML | 02230407 | Liquid - Intramuscular | 500 MG / ML | N/A |
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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