Overview
The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class, chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking dopamine receptors. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.
Indication
For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.
Associated Conditions
- Acute Intermittent Porphyria (AIP)
- Apprehension
- Defiant Disorder, Oppositional
- Intractable hiccups
- Mania
- Nausea and vomiting
- Restlessness
- Schizophrenia
- Tetanus
- Severe behavioural problems
- Short term Hyperactivity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/29 | Phase 1 | Recruiting | Capital Medical University | ||
2023/12/04 | Phase 1 | Completed | Whanin Pharmaceutical Company | ||
2023/04/27 | N/A | Recruiting | |||
2022/06/27 | Phase 1 | Withdrawn | Sadat City University | ||
2022/06/24 | Phase 2 | Recruiting | |||
2022/01/13 | Phase 1 | Active, not recruiting | |||
2020/04/29 | Phase 3 | Withdrawn | Centre Hospitalier St Anne | ||
2020/04/21 | Phase 2 | UNKNOWN | |||
2020/04/17 | N/A | UNKNOWN | |||
2020/01/13 | Phase 2 | UNKNOWN | Marco G Paggi, MD, PhD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Pharmaceuticals USA Inc. | 70710-1850 | INTRAMUSCULAR | 25 mg in 1 mL | 3/31/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0924 | ORAL | 25 mg in 1 1 | 5/21/2010 | |
| Alembic Pharmaceuticals Limited | 46708-737 | ORAL | 50 mg in 1 1 | 7/25/2023 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1132 | ORAL | 100 mg in 1 1 | 9/18/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1849 | INTRAMUSCULAR | 25 mg in 1 mL | 3/31/2023 | |
| Northstar Rx LLC | 16714-049 | ORAL | 50 mg in 1 1 | 9/18/2023 | |
| Chartwell RX, LLC | 62135-423 | ORAL | 100 mg in 1 1 | 10/5/2023 | |
| Northstar Rx LLC | 16714-050 | ORAL | 100 mg in 1 1 | 9/18/2023 | |
| Lannett Company, Inc. | 0527-2965 | ORAL | 200 mg in 1 1 | 2/19/2020 | |
| Upsher-Smith Laboratories, LLC | 0832-6018 | ORAL | 25 mg in 1 1 | 8/11/2021 |
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 |
|---|---|---|---|---|---|
| CHLORPROMAZINE 100 TABLET 100 mg | SIN07528P | TABLET, FILM COATED | 100 mg | 10/26/1993 | |
| CHLORPROMAZINE 25 TABLET 25 mg | SIN07195P | TABLET, FILM COATED | 25 mg | 10/12/1992 | |
| LARGO TABLETS 25 mg | SIN00095P | TABLET, FILM COATED | 25 mg | 3/16/1988 | |
| CHLORPROMAZINE HYDROCHLORIDE TABLET 50 mg | SIN06832P | TABLET, FILM COATED | 50 mg | 2/15/1992 | |
| LARGO TABLET 100 mg | SIN00096P | TABLET, FILM COATED | 100 mg | 3/16/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Chlorpromazine Hydrochloride Tablets | 国药准字H12020818 | 化学药品 | 片剂 | 8/6/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H34022480 | 化学药品 | 片剂 | 5/11/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H20057245 | 化学药品 | 片剂 | 9/29/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H50020120 | 化学药品 | 片剂 | 7/11/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H33021770 | 化学药品 | 片剂 | 1/18/2021 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H14020198 | 化学药品 | 片剂 | 8/17/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H41023649 | 化学药品 | 片剂 | 3/14/2024 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H33021327 | 化学药品 | 片剂 | 6/12/2020 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H41022506 | 化学药品 | 片剂 | 12/2/2019 | |
| Chlorpromazine Hydrochloride Tablets | 国药准字H34022491 | 化学药品 | 片剂 | 4/17/2020 |
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 |
|---|---|---|---|---|---|
| LARGACTIL SYRUP chlorpromazine hydrochloride 5mg/ml oral liquid | 118128 | Medicine | A | 5/2/2005 | |
| Largactil 50mg/2mL injection ampoule | 27511 | Medicine | A | 10/21/1991 | |
| LARGACTIL chlorpromazine hydrochloride 100mg tablet | 51619 | Medicine | A | 4/26/1995 | |
| LARGACTIL chlorpromazine hydrochloride 25mg tablet | 51618 | Medicine | A | 4/26/1995 |
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