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Thorazine (chlorpromazine)
Chlorpromazine (Thorazine), a generic drug originally developed by Rhône-Poulenc/Sanofi, is a marketed antipsychotic primarily indicated for acute intermittent porphyria. Its key strength lies in being the first antipsychotic drug, which revolutionized psychopharmacology by blocking dopamine D2 receptors. The primary risk is the key composition patent expiry in 2028, which may increase competition from other generics.
At a glance
| Generic name | chlorpromazine |
|---|---|
| Also known as | Thorazine, Largactil |
| Sponsor | Generic (originally Rhône-Poulenc/Sanofi) |
| Drug class | Typical antipsychotic (first-generation, phenothiazine) |
| Target | Aldehyde oxidase, Sphingomyelin phosphodiesterase, 5-hydroxytryptamine receptor 1E |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1954-03-26 (United States) |
Approved indications
- Acute intermittent porphyria
- Bipolar affective disorder, current episode manic
- Disruptive behavior disorder
- Intractable Hiccups
- Nausea and vomiting
- Pre-Op Apprehension
- Psychotic disorder
- Schizophrenia
- Tetanus Adjunct Treatment
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Common side effects
- Drowsiness
- Postural hypotension
- Dizziness
- Tachycardia
- Fainting
Serious adverse events
- Agranulocytosis
- Jaundice
- Aplastic anemia
- Sudden cardiac death
- Leukopenia
- Hemolytic anemia
- Thrombocytopenic purpura
- Pancytopenia
- EKG changes
- Extrapyramidal symptoms
Key clinical trials
- A Single-Center,Open-Label Clinical Study on the Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for (NA)
- Administration of Chlorpromazine as a Treatment for COVID-19 (Phase 2)
- Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affectiv (Phase 3)
- Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up. (Phase 4)
- An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects. (Phase 1)
- GiSAS Trial: Aripiprazole, Olanzapine, and Haloperidol in the Long Term Treatment of Schizophrenia. (Phase 4)
- TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (Phase 4)
- Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Thorazine CI brief — competitive landscape report
- Thorazine updates RSS · CI watch RSS
- Generic (originally Rhône-Poulenc/Sanofi) portfolio CI