NDAORALTABLET
Approved
Jan 1952
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Primaquine phosphate is an 8-aminoquinoline antimalarial small molecule oral tablet approved in 1952 for Plasmodium vivax malaria. It works by inhibiting the mitochondrial system of dormant parasites (hypnozoites) and generating oxidative stress through reactive metabolites, preventing relapse. The drug is also active against gametocytes of P. falciparum, making it a key agent for malaria elimination strategies.
$0.009BPart D
LOE ApproachingLow commercial volume ($9K Part D spending) and minimal linked job openings (0) indicate a niche, legacy product with minimal team expansion opportunity.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
Started Nov 2024
300 enrolled
Malaria, Vivax
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia
Started Aug 2023
2,999 enrolled
Vivax MalariaG6PD Deficiency
Primaquine Enantiomers in G6PD Deficient Human Volunteers
Started Sep 2020
18 enrolled
G6PD Deficiency
Phase 2 Efficacy Study of Primaquine and Methylene Blue
Started Jul 2016
80 enrolled
Malaria
Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria
Started Apr 2015
251 enrolled
Malaria, Vivax
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.