Chlorpromazine

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
Study on Hibernation-like Therapy Based on Mechanical Thrombectomy	2024/10/29	NCT06663631	Phase 1	Recruiting	Capital Medical University
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets	2023/12/04	NCT06154434	Phase 1	Completed	Whanin Pharmaceutical Company
Correlation of Genetic Variations With Clinical Response in Substance Use Disorder	2023/04/27	NCT05833399	N/A	Recruiting	Alexandria University
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer	2022/06/27	NCT05433402	Phase 1	Withdrawn	Sadat City University
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy	2022/06/24	NCT05431595	Phase 2	Recruiting	M.D. Anderson Cancer Center
Chlorpromazine and Standard of Care in Glioblastoma	2022/01/13	NCT05190315	Phase 1	Completed	Mohammed Milhem
Repurposing of Chlorpromazine in Covid-19 Treatment	2020/04/29	NCT04366739	Phase 3	Withdrawn	Centre Hospitalier St Anne
Administration of Chlorpromazine as a Treatment for COVID-19	2020/04/21	NCT04354805	Phase 2	UNKNOWN	Cairo University
Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures	2020/04/17	NCT04350528	N/A	UNKNOWN	University Hospital, Brest
Repurposing Chlorpromazine in the Treatment of Glioblastoma	2020/01/13	NCT04224441	Phase 2	UNKNOWN	Marco G Paggi, MD, PhD

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Chlorpromazine Hydrochloride	Zydus Pharmaceuticals USA Inc.	70710-1850	INTRAMUSCULAR	25 mg in 1 mL	3/31/2023
chlorpromazine hydrochloride	State of Florida DOH Central Pharmacy	53808-0924	ORAL	25 mg in 1 1	5/21/2010
Chlorpromazine	Alembic Pharmaceuticals Limited	46708-737	ORAL	50 mg in 1 1	7/25/2023
Chlorpromazine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	70710-1132	ORAL	100 mg in 1 1	9/18/2023
Chlorpromazine Hydrochloride	Zydus Pharmaceuticals USA Inc.	70710-1849	INTRAMUSCULAR	25 mg in 1 mL	3/31/2023
Chlorpromazine hydrochloride	Northstar Rx LLC	16714-049	ORAL	50 mg in 1 1	9/18/2023
chlorpromazine hydrochloride	Chartwell RX, LLC	62135-423	ORAL	100 mg in 1 1	10/5/2023
Chlorpromazine hydrochloride	Northstar Rx LLC	16714-050	ORAL	100 mg in 1 1	9/18/2023
Chlorpromazine Hydrochloride	Lannett Company, Inc.	0527-2965	ORAL	200 mg in 1 1	2/19/2020
Chlorpromazine Hydrochloride	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	REMEDICA LTD	SIN07528P	TABLET, FILM COATED	100 mg	10/26/1993
CHLORPROMAZINE 25 TABLET 25 mg	REMEDICA LTD	SIN07195P	TABLET, FILM COATED	25 mg	10/12/1992
LARGO TABLETS 25 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN00095P	TABLET, FILM COATED	25 mg	3/16/1988
CHLORPROMAZINE HYDROCHLORIDE TABLET 50 mg	REMEDICA LTD	SIN06832P	TABLET, FILM COATED	50 mg	2/15/1992
LARGO TABLET 100 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN00096P	TABLET, FILM COATED	100 mg	3/16/1988

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
LARGACTIL SYRUP chlorpromazine hydrochloride 5mg/ml oral liquid	118128	Clinect Pty Ltd	Medicine	A	5/2/2005
Largactil 50mg/2mL injection ampoule	27511	Clinect Pty Ltd	Medicine	A	10/21/1991
LARGACTIL chlorpromazine hydrochloride 100mg tablet	51619	Clinect Pty Ltd	Medicine	A	4/26/1995
LARGACTIL chlorpromazine hydrochloride 25mg tablet	51618	Clinect Pty Ltd	Medicine	A	4/26/1995

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CHLORPROMAZINE TABLETS B.P. 50MG	clonmel healthcare limited	01985450	Tablet - Oral	50 MG / TAB	12/31/1992
CHLORPROMANYL 40 DROPS SYR 44.5MG/ML	technilab pharma inc.	00690805	Syrup - Oral	44.5 MG / ML	12/31/1986
CHLORPROM TAB 25MG	icn canada ltd.	00295086	Tablet - Oral	27.9 MG / TAB	12/31/1974
CHLORPROMAZINE TABLETS B.P. 25MG	clonmel healthcare limited	01985434	Tablet - Oral	25 MG / TAB	12/31/1992
CHLORPROM TAB 100MG	icn canada ltd.	00271128	Tablet - Oral	111.6 MG / TAB	12/31/1962
APO CHLORPROMAZINE	Apotex Inc	00312703	Tablet - Oral	27.9 MG	12/31/1976
NOVO-CHLORPROMAZINE 200MG	novopharm limited	00021342	Tablet - Oral	223.2 MG	12/31/1970
LARGACTIL SUP 100MG	sanofi-aventis canada inc	01930001	Suppository - Rectal	100 MG	12/31/1952
APO CHLORPROMAZINE	Apotex Inc	00312673	Tablet - Oral	55.7 MG	12/31/1976
CHLORPROMAZINE TABLETS B.P. 100MG	clonmel healthcare limited	01985442	Tablet - Oral	100 MG / TAB	12/31/1992

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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