PRAZIQUANTEL
Details
- Status
- Prescription
- First Approved
- 2017-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET
PRAZIQUANTEL Approval History
What PRAZIQUANTEL Treats
3 indicationsPRAZIQUANTEL is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schistosomiasis
- Clonorchiasis
- Opisthorchiasis
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.
PRAZIQUANTEL FDA Label Details
ProIndications & Usage
Praziquantel tablets are indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Praziquantel tablets are an anthelmintic indicated in patients aged one year and older for the treatment of the followin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.