TheraRadar
Data updated: Sep 20, 2026

PRIMAQUINE (primaquine phosphate) · Sanofi

Trial Activity: Declining 2 active trials
Infectious Disease Approved 1952-01-23

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Menzies School of Health Research conducting 7 trials (15%)
29 indications explored (Broad Platform)
→ malaria (16 trials)
→ malaria, vivax (11 trials)
→ vivax malaria (9 trials)
1
Indication
--
Phase 3 Trials
74
Years on Market

Details

Status
Prescription
First Approved
1952-01-23
Routes
ORAL
Dosage Forms
TABLET

Companies

Sanofi
Active Ingredient: PRIMAQUINE PHOSPHATE

PRIMAQUINE Approval History

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Original
New Indication
New Form
Label Update
18 FDA actions from 1952 to 2026
Feb 2026 SUPPL
Label · Labeling
Label
Mar 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2017 SUPPL
Label · Labeling
FDA Letter Label

What PRIMAQUINE Treats

1 FDA approvals

Originally approved for its first indication in 1952 .

  • Other (1)
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Clinical Trial Registry

44 trials
Trial Sponsor ID Phase Status Title
NCT06666491 208550 Ph 3 recruiting 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
NCT06148792 TADORE TADORE Ph 3 recruiting A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
NCT06191458 PBC MAL23004 Ph 4 completed Postpartum Primaquine in Breast Milk
NCT04706130 results posted 20-0010 Ph 4 completed Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
NCT04704999 SEADOT MAL20005 21-0023 Ph 4 recruiting Southeast Asia Dose Optimization of Tafenoquine
NCT03529396 CAAE: 70177317.1.0000.0005 Ph 2 completed Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients
NCT05044637 CHILDPRIM CAAE: 50193921.6.1001.0005 Ph 2 completed Study to Evaluate Primaquine for Radical Cure of Uncomplicated Plasmodium Vivax Malaria in Children
NCT06294912 7602-003 MK-7602-003 Ph 1 completed A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
NCT04411836 EFFORT EFFORT Ph 3 completed Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine
NCT05550909 NECTAR4 28041 Ph 2 completed Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali
NCT04079621 SIRIN Ph 4 completed Short Course Radical Cure of P. Vivax Malaria in Nepal
NCT04661579 results posted CVIA 078 PACTR202006896481432 Ph 2 completed Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy
NCT04280692 CHMI-TransMod KEMRI/SERU/CGMR-C/117/3759 OxTREC 48-18 Ph 1, Ph 2 suspended Controlled Human Malaria Infection Transmission Model - Phase A
NCT04984759 TBM MAL21004 Ph 4 withdrawn Tafenoquine and Primaquine in Colostrum and Breast Milk
NCT02389374 results posted PR-14053 Ph 4 completed A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
NCT03916003 PRIMA 19-3288 Ph 4 completed Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas
NCT06044805 CQ+PQ EPHI-IRB-294-2 Ph 4 completed Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
NCT06036030 MCMPFPB MCMPFPB2019 Ph 2 completed Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
NCT05829187 MCHUPF B-056/FI2/KEPK/TL.00/10/2022 Ph 2 completed Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
NCT03352843 ESSLDPQP4502D6 TMA2016CDF-1555 Ph 4 completed Single Low-dose Primaquine Efficacy and Safety.
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
NCT03337152 results posted 856370-2 Ph 4 terminated Assessing a Risk Model for G6PD Deficiency
NCT02960568 WR2253 D6.7_14_I_14_J9_837 Ph 1 completed Genetic Variability in CYP2D6 in U.S Active Duty Population
NCT03783299 17-22577 A124497 Ph 4 completed Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic
NCT02802501 results posted 200894 Ph 3 completed Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria
NCT02431650 OZGAM results posted QP15C05 Ph 1, Ph 2 completed Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent
NCT02851108 BlueACTn results posted UniHD008 Ph 2 completed Methylene Blue Against Falciparum Malaria in Burkina Faso
NCT02696954 ALAQPQ ALAQPQ Ph 1, Ph 2 terminated Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects
NCT03934450 PQ Study 2 Ph 1 completed Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen
NCT02216123 results posted 116564 Ph 3 completed Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria
NCT01205178 110027 Ph 1 completed G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
NCT02535767 PQSAFETY 14-14495 Ph 1, Ph 2 completed Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali
NCT01680406 CDC-CGH-6338 Ph 4 completed Ethiopia Antimalarial in Vivo Efficacy Study 2012
NCT02434952 015NECHR Ph 4 completed Safety and Tolerability of Low Dose Primaquine
NCT02789566 PQ in Obese TMEC 11-010 Ph 1 completed Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult Subjects
NCT02691910 404067/2012-3 550.565 Ph 2, Ph 3 completed Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection
NCT01780753 SMRU1203 Ph 1 completed Primaquine Pharmacokinetics in Lactating Women and Their Infants
NCT02259426 DAPPI DAPPI-1 Ph 3 completed Dihydroartemisinin-piperaquine With Low Dose Primaquine to Reduce Malaria Transmission
NCT01708876 ACT KNOW NMRR-12-89-11005 Ph 3 completed P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine
NCT02394197 EMTM INSP CI-624 PAHO-MEX/07/005015, PAHOERC-162-MEX Ph 4 completed Effectiveness of Malaria Treatment in Mexico
NCT02143934 07200734 Ph 4 completed Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity
NCT01878357 MTC Belu Ph 4 completed Surveillance and Treatment With Dihydroartemisinin-piperaquine Plus Primaquine
NCT01365598 PQPF912 Ph 3 completed Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda
NCT01500980 ITV MC-003 Ph 1 completed Malaria Challenge in Healthy Volunteers
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 FDA Label Details

Indications & Usage

FDA Label (PDF)

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.

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Data Sources

FDA Approval: NDA008316 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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