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Primaquine

(primaquine)

ApprovedSmall molecule

Primaquine is used to treat malaria, particularly to prevent the disease from recurring by killing parasites that hide in the liver. It's also used to treat a lung infection called pneumocystis pneumonia in people with weakened immune systems.[2] Primaquine is currently approved and in use across 7 indications[4].[1]

Primaquine is one of 186 small molecule programs targeting Glucosephosphate Dehydrogenase Deficiency. It is currently in Approved.

7

Indications

65

Total Trials

3

Active Trials

185

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Glucosephosphate Dehydrogenase DeficiencyApproved

ObesityApproved

PneumoniaActive, not recruiting

EfficacyCompleted

DrugCompleted

MalariaCompleted

Plasmodium Vivax MalariaCompleted

Glucosephosphate Dehydrogenase DeficiencyApproved

Approved

ObesityApproved

Approved

PneumoniaPreclinical

Active, not recruiting

EfficacyPreclinical

Completed

DrugPreclinical

Completed

MalariaApproved

Completed

Plasmodium Vivax MalariaApproved

Completed

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Primaquine

NNC0487-0111

Cagrisema

Gemtesa

Sumitomo Pharma America, Inc.

Zenagamtide

Berobenatide

Ribupatide

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Survodutide

Boehringer Ingelheim

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Malaria

NCT06148792

Q1 2028

ApprovedRecruiting

Plasmodium Vivax Malaria

NCT04704999

Clinical

Trials by Indication[1]

Malaria21 trials

Short Course Radical Cure of P. Vivax Malaria in Nepal

Completed·MMenzies School of Health Research·Phase 4·NCT04079621·27 enrolled

Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil

Completed·CCenters for Disease Control and Prevention·N/A·NCT03610399·257 enrolled

Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients

Completed·FFundação de Medicina Tropical Dr. Heitor Vieira Dourado·Phase 2·NCT03529396·106 enrolled

Show 18 more trials

Malaria Elimination Pilot Study in Military Forces in Cambodia

Unknown status·—·Phase 4·NCT02653898·1,050 enrolled

Dihydroartemisinin-piperaquine With Low Dose Primaquine to Reduce Malaria Transmission

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT02259426·120 enrolled

A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

Completed·MMenzies School of Health Research·Phase 4·NCT02389374·181 enrolled

Methylene Blue Against Falciparum Malaria in Burkina Faso

Completed·HHeidelberg University·Phase 2·NCT02851108·100 enrolled

Effectiveness of Malaria Treatment in Mexico

Completed·LLILIA GONZALEZ CERON·Phase 4·NCT02394197·153 enrolled

Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria

Completed· GSK logo

GSK·Phase 3·NCT02802501·150 enrolled

Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

Completed·MMenzies School of Health Research··NCT01716260·24 enrolled

Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

Completed·UUniversity of California, San Francisco·Phase 1/2·NCT02535767·28 enrolled

IMPROV (Improving the Radical Cure of Vivax Malaria)

Completed·UUniversity of Oxford·N/A·NCT01814683·2,388 enrolled

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Recruiting·MMenzies School of Health Research·Phase 3·NCT06148792·1,090 enrolled

Malaria Challenge in Healthy Volunteers

Completed·SSeattle Children's Hospital·Phase 1·NCT01500980·36 enrolled

Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy

Completed·PPATH·Phase 2·NCT04661579·620 enrolled

Controlled Human Malaria Infection Transmission Model - Phase A

Suspended·UUniversity of Oxford·Phase 1/2·NCT04280692·44 enrolled

Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT00158587·150 enrolled

Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT01365598·468 enrolled

Ethiopia Antimalarial in Vivo Efficacy Study 2012

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT01680406·398 enrolled

A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06294912·16 enrolled

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

Recruiting· GSK logo

GSK·Phase 3·NCT06666491·300 enrolled

Treatment4 trials

Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax

Completed·DDinka Dugassa·Phase 4·NCT06044805·100 enrolled

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000640·290 enrolled

Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

Completed·PPapua New Guinea Institute of Medical Research·Phase 4·NCT02143934·524 enrolled

Show 1 more trial

Surveillance and Treatment With Dihydroartemisinin-piperaquine Plus Primaquine

Completed·IIndonesia University·Phase 4·NCT01878357·1,488 enrolled

ART4 trials

TES of Artemether-lumefantrine for Pf in the Philippines in 2017-2018

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT05958810·80 enrolled

Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects

Terminated·UUniversity of Oxford·Phase 1/2·NCT02696954·17 enrolled

TES of Artemether-lumefantrine for Pf in the Philippines in 2015

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT05958693·82 enrolled

Show 1 more trial

TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT04222088·159 enrolled

Plasmodium vivax malaria3 trials

Study to Evaluate Primaquine for Radical Cure of Uncomplicated Plasmodium Vivax Malaria in Children

Completed·FFundação de Medicina Tropical Dr. Heitor Vieira Dourado·Phase 2·NCT05044637·100 enrolled

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Completed· GSK logo

GSK·Phase 3·NCT02216123·251 enrolled

Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia

Recruiting·UUniversity of Oxford·Approved·NCT04704999·820 enrolled

Efficacy2 trials

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT04706130·160 enrolled

Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil

Completed·CCenters for Disease Control and Prevention·N/A·NCT02043652·119 enrolled

20 more indications

Plasmodium Vivax Infection2 trials

Investigation of Short Course, High Dose Primaquine Treatment for Liver Stages of Plasmodium Vivax Infection

Unknown status·PPapua New Guinea Institute of Medical Research·Phase 4·NCT02364583·150 enrolled

Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

Completed·OOswaldo Cruz Foundation·Phase 2/3·NCT02691910·204 enrolled

Plasmodium Falciparum2 trials

Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT02223871·8 enrolled

Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

Completed·SSyamsudin Abdillah,Ph.D, Pharm D·Phase 2·NCT06036030·50 enrolled

G6PD Deficiency2 trials

A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Completed·WWalter Reed Army Institute of Research (WRAIR)·N/A·NCT00076323·14 enrolled

Assessing a Risk Model for G6PD Deficiency

Terminated·PPATH·Phase 4·NCT03337152·54 enrolled

Efficacy and Safety2 trials

Single Low-dose Primaquine Efficacy and Safety.

Completed·—·Phase 4·NCT03352843·157 enrolled

Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes

Completed·MMuhimbili University of Health and Allied Sciences·Phase 4·NCT02090036·220 enrolled

Breast2 trials

Tafenoquine and Primaquine in Colostrum and Breast Milk

Withdrawn·UUniversity of Oxford·Phase 4·NCT04984759

Postpartum Primaquine in Breast Milk

Completed·UUniversity of Oxford·Phase 4·NCT06191458·12 enrolled

Effectiveness2 trials

Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent

Completed· Medicines for Malaria Venture logo

Medicines for Malaria Venture·Phase 1/2·NCT02431650·11 enrolled

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Completed·MMenzies School of Health Research·Phase 3·NCT04411836·960 enrolled

Lip1 trial

TES of Chloroquine for Pv in the Philippines in 2016

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT05958797·74 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Primaquine for P. Vivax

Unknown status·MMenzies School of Health Research·N/A·NCT01837992·180 enrolled

Prevention1 trial

Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse

Completed· GSK logo

GSK·Phase 2·NCT01376167·851 enrolled

Combination Therapy1 trial

Trial of Artesunate Combination Therapy in Pakistan

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT00959517·588 enrolled

Infants1 trial

Primaquine Pharmacokinetics in Lactating Women and Their Infants

Completed·UUniversity of Oxford·Phase 1·NCT01780753·20 enrolled

Hemolysis1 trial

G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)

Completed· GSK logo

GSK·Phase 1·NCT01205178·192 enrolled

Trial1 trial

P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine

Completed·MMenzies School of Health Research·Phase 3·NCT01708876·250 enrolled

Drug1 trial

Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

Completed·UUniversity of California, San Francisco·N/A·NCT04864444·10,715 enrolled

Adult Subject1 trial

Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult Subjects

Completed·UUniversity of Oxford·Phase 1·NCT02789566·10 enrolled

Plasmodium falciparum malaria1 trial

Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

Completed·SSyamsudin Abdillah,Ph.D, Pharm D·Phase 2·NCT05829187·36 enrolled

Infections1 trial

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas

Completed·MMenzies School of Health Research·Phase 4·NCT03916003·500 enrolled

Biomarkers1 trial

Biomarkers of P. Vivax Relapse

Unknown status·—·N/A·NCT04228315·100 enrolled

Pneumonia1 trial

The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000717·50 enrolled

Unspecified6 trials

Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand

Completed·—··NCT05753150·187 enrolled

Incidence of Vivax Along the Thai Burma Border

Completed·UUniversity of Oxford·N/A·NCT01076868·403 enrolled

Genetic Variability in CYP2D6 in U.S Active Duty Population

Completed·WWalter Reed Army Institute of Research (WRAIR)·Phase 1·NCT02960568·550 enrolled

Show 3 more trials

Safety and Tolerability of Low Dose Primaquine

Completed·MMalaria Consortium·Phase 4·NCT02434952·109 enrolled

Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays

Completed·PPATH··NCT04666350·42 enrolled

Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil

Unknown status·FFundação de Medicina Tropical Dr. Heitor Vieira Dourado··NCT05096702·16,000 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PRIMAQUINE

NDA NDA008316

Sources

References

[1]
ClinicalTrials.gov — 65 trial records for primaquine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Primaquine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — primaquine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for primaquine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA008316). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

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