Malaria

Infectious Diseases
35
Pipeline Programs
13
Companies
50
Clinical Trials
3 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
13
6
7
0
3
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
2100%
+ 45 programs with unclassified modality

On Market (1)

Approved therapies currently available

Amivas
ARTESUNATEApproved
artesunate
Amivas
intravenous2020

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
7 programs
2
3
1
1
Artemether-lumefantrinePhase 45 trials
RACDPhase 31 trial
KAE609Phase 21 trial
KAE609Phase 21 trial
KAE609Phase 21 trial
+2 more programs
Active Trials
NCT05330273Completed14Est. Nov 2022
NCT05084651Completed19Est. May 2022
NCT03334747Completed188Est. Nov 2019
+8 more trials
Sanofi
SanofiPARIS, France
6 programs
1
1
1
3
ArtesunatePhase 41 trial
ArtesunatePhase 41 trial
CoarsucamPhase 41 trial
Artesunate + AmodiaquinePhase 35 trials
SAR97276APhase 22 trials
+1 more programs
Active Trials
NCT00563914Completed72Est. Nov 2008
NCT01445938Terminated20Est. Jan 2012
NCT00739206Terminated113Est. Jun 2009
+8 more trials
Amivas
AmivasIreland - Waterford
1 program
1
Artesunate InjectionN/A1 trial
Active Trials
NCT06555809RecruitingEst. Feb 2030
Akros Pharma
Akros PharmaNJ - Princeton
1 program
1
Reactive Focal Drug AdministrationPhase 41 trial
Active Trials
NCT02654912Completed8,682Est. Jul 2020
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
13 programs
5
1
1
Antimalarial monoclonal antibodiesPhase 31 trial
AMA1-C1/Alhydrogel® + CPG 7909Phase 1/21 trial
AMA1/AlhydrogelPhase 11 trial
Ad35.CS.01 Circumsporozoite Malaria VaccinePhase 1Vaccine1 trial
DM1157Phase 11 trial
+8 more programs
Active Trials
NCT03810014CompletedEst. Oct 2019
NCT04428307CompletedEst. Aug 2022
NCT01265407CompletedEst. Jul 2013
+10 more trials
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
5 programs
3
Methylenblue-AmodiaquinePhase 21 trial
Methylene bluePhase 21 trial
Sulphadoxine-pyrimethaminePhase 21 trial
ITN distribution channelN/A1 trial
Malaria Birth Cohort (MBC) in Agogo, GhanaN/A1 trial
Active Trials
NCT00355225Completed
NCT04050566Unknown1,800Est. Apr 2025
NCT00545935Completed186Est. Oct 2007
+2 more trials
QT
Q TherapeuticsUT - Salt Lake City
7 programs
3
4
DSM265Phase 1/21 trial
DSM265Phase 1/21 trial
MMV390048 40mgPhase 1/21 trial
OZ439Phase 1/21 trial
480 mg Piperaquine phosphatePhase 11 trial
+2 more programs
Active Trials
NCT03542149CompletedEst. Apr 2019
NCT02431637CompletedEst. Sep 2016
NCT02783820CompletedEst. Dec 2016
+4 more trials
E
EisaiChina - Liaoning
2 programs
2
E1018Phase 11 trial
SJ733Phase 11 trial
Active Trials
NCT06854042Recruiting32Est. Dec 2025
NCT02661373Completed44Est. Mar 2018
M&
Merck & Co.RAHWAY, NJ
1 program
1
Plasmodium falciparumPhase 11 trial
Active Trials
NCT06294912Completed16Est. Jan 2025
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
TransfluthrinN/A1 trial
Transfluthrin - delivery by paid study personnelN/A1 trial
Active Trials
NCT04795648Completed1,911Est. Mar 2024
NCT06122142Withdrawn0Est. May 2025
Precision BioSciences
1 program
MalariaSense deviceN/A1 trial
Active Trials
NCT02672228Completed208Est. Dec 2015
Abbott
AbbottABBOTT PARK, IL
1 program
NxTekTM Malaria Pf Plus Rapid Diagnostic Test DeviceN/A1 trial
Active Trials
NCT05286359Completed1,023Est. Nov 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Akros PharmaReactive Focal Drug Administration
SanofiArtesunate + Amodiaquine
SanofiCoarsucam
NovartisArtemether-lumefantrine
SanofiArtesunate
NovartisArtemether-lumefantrine
SanofiArtesunate
Allergy TherapeuticsAntimalarial monoclonal antibodies
NovartisRACD
SanofiArtesunate + Amodiaquine
NovartisArtemether-lumefantrine
SanofiArtesunate + Amodiaquine
NovartisArtemether-lumefantrine
NovartisArtemether-lumefantrine
NovartisKAE609

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 29,362 patients across 50 trials

NCT02654912Akros PharmaReactive Focal Drug Administration

Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration

Start: Feb 2016Est. completion: Jul 20208,682 patients
Phase 4Completed
NCT01023399SanofiArtesunate + Amodiaquine

Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Start: Nov 2009Est. completion: Oct 2013580 patients
Phase 4Completed
NCT00699920SanofiCoarsucam

Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Start: Jun 2008Est. completion: Jun 2010413 patients
Phase 4Completed
NCT00444106NovartisArtemether-lumefantrine

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

Start: May 2007Est. completion: Nov 2008265 patients
Phase 4Completed
NCT00452907SanofiArtesunate

ACT MALI: Treatment of Malaria Based on Combination Therapies

Start: Jul 2005Est. completion: Jun 2007780 patients
Phase 4Completed
NCT00386750NovartisArtemether-lumefantrine

Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

Start: Jun 2005Est. completion: Nov 2005265 patients
Phase 4Terminated
NCT00445796SanofiArtesunate

Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Start: Jun 2005300 patients
Phase 4Completed
NCT07082205Allergy TherapeuticsAntimalarial monoclonal antibodies

Monoclonal Antibodies in Children With Severe Anaemia or Severe Malaria to Prevent Malaria After Hospital Discharge

Start: May 2025Est. completion: Apr 2027
Phase 3Recruiting
NCT02610400NovartisRACD

Evaluation of Reactive Focal Mass Drug Administration (rfMDA) +/- Reactive Focal Vector Control (RAVC) in Namibia

Start: Feb 2016Est. completion: Dec 20179,845 patients
Phase 3Completed
NCT01378286SanofiArtesunate + Amodiaquine

Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Start: Jan 2012Est. completion: Jun 2013380 patients
Phase 3Completed
NCT00386763NovartisArtemether-lumefantrine

Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Start: Aug 2006Est. completion: Mar 2007890 patients
Phase 3Completed
NCT00316329SanofiArtesunate + Amodiaquine

ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria

Start: Mar 20061,032 patients
Phase 3Completed
NCT00709969NovartisArtemether-lumefantrine

Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Start: Jul 2002Est. completion: Feb 2003310 patients
Phase 3Completed
NCT04300309NovartisArtemether-lumefantrine

Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

Start: Dec 2020Est. completion: May 202428 patients
Phase 2/3Terminated
NCT03334747NovartisKAE609

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Start: Nov 2017Est. completion: Nov 2019188 patients
Phase 2Completed
NCT02831023Heidelberg PharmaSulphadoxine-pyrimethamine

Phase 2 Efficacy Study of Primaquine and Methylene Blue

Start: Jul 2016Est. completion: Jan 201780 patients
Phase 2Completed
NCT01836458NovartisKAE609

A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection

Start: Jan 2014Est. completion: Mar 201525 patients
Phase 2Completed
NCT01524341NovartisKAE609

Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Start: Jan 2012Est. completion: Jun 201227 patients
Phase 2Completed
NCT01445938SanofiSAR97276A

Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Start: Oct 2011Est. completion: Jan 201220 patients
Phase 2Terminated
NCT00739206SanofiSAR97276A

Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

Start: Aug 2008Est. completion: Jun 2009113 patients
Phase 2Terminated
NCT00545935Heidelberg PharmaMethylenblue-Amodiaquine

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso

Start: Jul 2007Est. completion: Oct 2007186 patients
Phase 2Completed
NCT00354380Heidelberg PharmaMethylene blue

Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

Start: Sep 2006Est. completion: Nov 2006
Phase 2Completed
NCT02783833Q TherapeuticsMMV390048 40mg

MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B

Start: May 2016Est. completion: Jan 2017
Phase 1/2Completed
NCT02573857Q TherapeuticsDSM265

A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection

Start: Oct 2015Est. completion: May 2016
Phase 1/2Terminated
NCT02431650Q TherapeuticsOZ439

Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent

Start: Apr 2015Est. completion: Sep 2016
Phase 1/2Completed
NCT02389348Q TherapeuticsDSM265

A Phase Ib Induced Malaria Infection Study With the Combination of OZ439 and DSM265

Start: Feb 2015Est. completion: Jun 2015
Phase 1/2Completed
NCT00984763Allergy TherapeuticsAMA1-C1/Alhydrogel® + CPG 7909

A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria

Start: Jan 2010Est. completion: Sep 2010
Phase 1/2Completed
NCT00563914Sanofiferroquine

A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

Start: Oct 2007Est. completion: Nov 200872 patients
Phase 1/2Completed
NCT06854042EisaiE1018

A Study of Oral E1018 in Healthy Adult Participants

Start: Feb 2025Est. completion: Dec 202532 patients
Phase 1Recruiting
NCT06461026Allergy TherapeuticsL9LS

L9LS MAb in Malian Infants

Start: Aug 2024Est. completion: Jun 2026
Phase 1Active Not Recruiting
NCT06294912Merck & Co.Plasmodium falciparum

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

Start: Apr 2024Est. completion: Jan 202516 patients
Phase 1Completed
NCT05604521Allergy TherapeuticsPfSPZ Vaccine

A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI

Start: Dec 2022Est. completion: Sep 2023
Phase 1Terminated
NCT05330273NovartisGanaplacide

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz

Start: Apr 2022Est. completion: Nov 202214 patients
Phase 1Completed
NCT05084651NovartisGanaplacide

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole

Start: Nov 2021Est. completion: May 202219 patients
Phase 1Completed
NCT03490162Allergy TherapeuticsDM1157

Safety and Pharmacokinetics Study of DM1157 to Treat Malaria

Start: Jul 2018Est. completion: Sep 2019
Phase 1Terminated
NCT03542149Q Therapeutics480 mg Piperaquine phosphate

Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP

Start: Apr 2018Est. completion: Apr 2019
Phase 1Completed
NCT02783820Q TherapeuticsMMV390048 40 mg

Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A

Start: May 2016Est. completion: Dec 2016
Phase 1Completed
NCT02661373EisaiSJ733

First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor

Start: Mar 2016Est. completion: Mar 201844 patients
Phase 1Completed
NCT02431637Q TherapeuticsAdministration of the malaria inoculum

Experimental Falciparum Transmission to Anopheles

Start: Apr 2015Est. completion: Sep 2016
Phase 1Completed
NCT01018459Allergy TherapeuticsAd35.CS.01 Circumsporozoite Malaria Vaccine

Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso

Start: Apr 2010Est. completion: Dec 2011
Phase 1Completed
NCT00386503SanofiArtesunate + Amodiaquine

Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions

Start: Jun 200622 patients
Phase 1Completed
NCT00114010Allergy TherapeuticsAMA1/Alhydrogel

Experimental Vaccine for Malaria

Start: Apr 2005Est. completion: Dec 2006
Phase 1Completed
NCT00355225Heidelberg PharmaITN distribution channel

Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso

N/ACompleted
NCT06555809AmivasArtesunate Injection

Evaluation of Artesunate in Infants Being Treated for Severe Malaria

Start: Oct 2024Est. completion: Feb 2030
N/ARecruiting
NCT06122142Johnson & JohnsonTransfluthrin - delivery by paid study personnel

Spatial Repellents for Malaria Control

Start: May 2024Est. completion: May 20250
N/AWithdrawn
NCT05950191Allergy Therapeuticslong lasting insecticidal nets with chlorfenapyr-pyrethroid

LLIN Evaluation in Uganda Project (LLINEUP3)

Start: Nov 2023Est. completion: Dec 2025
N/ACompleted
NCT05286359AbbottNxTekTM Malaria Pf Plus Rapid Diagnostic Test Device

Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria

Start: May 2022Est. completion: Nov 20221,023 patients
N/ACompleted
NCT04795648Johnson & JohnsonTransfluthrin

Spatial Repellents for Vector Control

Start: Jul 2021Est. completion: Mar 20241,911 patients
N/ACompleted
NCT04428307Allergy TherapeuticsConditional artemisinin combination therapy subsidy

Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Kenya

Start: Jan 2021Est. completion: Aug 2022
N/ACompleted
NCT04050566Heidelberg PharmaMalaria Birth Cohort (MBC) in Agogo, Ghana

Malaria Birth Cohort (MBC) in Agogo, Ghana

Start: Apr 2019Est. completion: Apr 20251,800 patients
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 29,362 patients
13 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)