PROCOMP (prochlorperazine maleate)
Procomp (prochlorperazine maleate) is indicated for the control of severe nausea and vomiting and the treatment of schizophrenia. It is also approved for the short-term treatment of generalized non-psychotic anxiety; however, it is not considered first-line therapy because it carries risks—specifically tardive dyskinesia—not shared by alternatives like benzodiazepines. When used for anxiety, Procomp must not exceed a dosage of 20 mg per day or a treatment duration of 12 weeks, as exceeding these limits increases the risk of developing irreversible tardive dyskinesia. It has not been shown effective for managing behavioral complications in patients with mental retardation.
How PROCOMP Works
Prochlorperazine is a piperazine phenothiazine that acts as a potent dopamine D2 receptor antagonist. Its antiemetic properties are primarily due to the blockade of dopamine receptors in the chemoreceptor trigger zone (CTZ) of the medulla. Its antipsychotic and anxiolytic effects are mediated by the blockade of postsynaptic D2 receptors in the mesolimbic and mesocortical pathways of the central nervous system. Additionally, the drug possesses alpha-adrenergic blocking and weak anticholinergic activity.
Details
- Status
- Prescription
- First Approved
- 1998-02-27
- Routes
- ORAL
- Dosage Forms
- TABLET
PROCOMP Approval History
What PROCOMP Treats
5 indicationsPROCOMP is approved for 5 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
- Schizophrenia
- Anxiety
- Generalized Anxiety Disorder
PROCOMP Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06450899 | 23-0958 | Ph 2 | completed | Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROCOMP FDA Label Details
Indications & Usage
FDA Label (PDF)PROCOMP is indicated for the treatment of Nausea; Vomiting; Schizophrenia; Anxiety; Generalized Anxiety Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.