PRIMAQUINE PHOSPHATE · INGENUS PHARMS LLC
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1952-01-23
- Routes
- ORAL
- Dosage Forms
- TABLET
PRIMAQUINE PHOSPHATE Approval History
What PRIMAQUINE PHOSPHATE Treats
3 FDA approvalsOriginally approved for its first indication in 2014 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Feb 2014)Letter
- • Approved indication (Feb 2014)
- • Approved indication (Jun 2016)
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05550909 NECTAR4 | 28041 | Ph 2 | completed | Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali |
| NCT05081089 NECTAR3 | 26257 | Ph 2 | completed | Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali |
| NCT03783299 | 17-22577 A124497 | Ph 4 | completed | Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic |
| NCT03934450 | PQ Study 2 | Ph 1 | completed | Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen |
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.
PRIMAQUINE PHOSPHATE FDA Label Details
Indications & Usage
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.
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Full clinical data, patents, trials, and competitive landscape for primaquine phosphate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment