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Condition (MeSH)

Malaria

ClinicalTrials.gov lists 1,376 trials for Malaria or a narrower condition beneath it. National Institute of Allergy and Infectious Diseases (NIAID) has the most among industry and government lead sponsors, with 120.

MeSH D008288 Infections C01 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 263 Phase 1/2 Phase 1/2 70 Phase 2 Phase 2 141 Phase 2/3 Phase 2/3 35 Phase 3 Phase 3 171 Phase 4 Phase 4 202 Not applicable Not applicable 271 Observational Observational 222 Phase 1 Phase 1 263 Phase 1/2 Phase 1/2 70 Phase 2 Phase 2 141 Phase 2/3 Phase 2/3 35 Phase 3 Phase 3 171 Phase 4 Phase 4 202 Not applicable Not applicable 271 Observational Observational 222

Trials per phase

1 more section with rows

1,132 of the 1,376 trials are tagged with Malaria itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Malaria trials start? (32)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 4 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 78

1993: 1 trials (Phase 4 1) 1995: 1 trials (Not applicable 1) 1997: 1 trials (Phase 2 1) 1998: 3 trials (Observational 1, Not applicable 1, Phase 2 1) 1999: 2 trials (Not applicable 1, Phase 1 1) 2000: 6 trials (Observational 1, Not applicable 1, Phase 4 1, Phase 3 1, Phase 2 2) 2001: 6 trials (Phase 4 3, Phase 3 2, Phase 1/2 1) 2002: 23 trials (Observational 2, Not applicable 6, Phase 4 6, Phase 3 4, Phase 2/3 1, Phase 2 2, Phase 1/2 1, Phase 1 1) 2003: 31 trials (Not applicable 5, Phase 4 8, Phase 3 9, Phase 2/3 2, Phase 2 3, Phase 1/2 1, Phase 1 3) 2004: 38 trials (Observational 4, Not applicable 7, Phase 4 3, Phase 3 10, Phase 2/3 4, Phase 2 2, Phase 1/2 3, Phase 1 5) 2005: 54 trials (Observational 7, Not applicable 9, Phase 4 11, Phase 3 5, Phase 2/3 2, Phase 2 8, Phase 1/2 2, Phase 1 10) 2006: 65 trials (Observational 12, Not applicable 9, Phase 4 8, Phase 3 9, Phase 2 11, Phase 1/2 7, Phase 1 9) 2007: 57 trials (Observational 7, Not applicable 6, Phase 4 11, Phase 3 12, Phase 2/3 3, Phase 2 7, Phase 1/2 1, Phase 1 10) 2008: 43 trials (Observational 9, Not applicable 9, Phase 4 7, Phase 3 4, Phase 2/3 2, Phase 2 5, Phase 1 7) 2009: 55 trials (Observational 7, Not applicable 9, Phase 4 10, Phase 3 8, Phase 2/3 1, Phase 2 2, Phase 1/2 3, Phase 1 15) 2010: 74 trials (Observational 18, Not applicable 13, Phase 4 10, Phase 3 11, Phase 2/3 3, Phase 2 3, Phase 1/2 4, Phase 1 12) 2011: 59 trials (Observational 5, Not applicable 13, Phase 4 11, Phase 3 9, Phase 2 7, Phase 1/2 5, Phase 1 9) 2012: 57 trials (Observational 2, Not applicable 15, Phase 4 10, Phase 3 7, Phase 2/3 1, Phase 2 3, Phase 1/2 5, Phase 1 14) 2013: 61 trials (Observational 9, Not applicable 13, Phase 4 9, Phase 3 8, Phase 2/3 1, Phase 2 7, Phase 1/2 5, Phase 1 9) 2014: 70 trials (Observational 5, Not applicable 18, Phase 4 13, Phase 3 7, Phase 2/3 4, Phase 2 5, Phase 1/2 1, Phase 1 17) 2015: 66 trials (Observational 12, Not applicable 12, Phase 4 6, Phase 3 6, Phase 2/3 4, Phase 2 3, Phase 1/2 5, Phase 1 18) 2016: 78 trials (Observational 17, Not applicable 12, Phase 4 7, Phase 3 7, Phase 2 7, Phase 1/2 8, Phase 1 20) 2017: 40 trials (Observational 8, Not applicable 5, Phase 4 5, Phase 3 5, Phase 2 6, Phase 1/2 2, Phase 1 9) 2018: 54 trials (Observational 12, Not applicable 11, Phase 4 5, Phase 3 7, Phase 2 5, Phase 1/2 1, Phase 1 13) 2019: 48 trials (Observational 11, Not applicable 10, Phase 4 4, Phase 3 5, Phase 2/3 2, Phase 2 7, Phase 1/2 4, Phase 1 5) 2020: 50 trials (Observational 15, Not applicable 12, Phase 4 5, Phase 3 5, Phase 2/3 1, Phase 2 2, Phase 1/2 1, Phase 1 9) 2021: 72 trials (Observational 19, Not applicable 18, Phase 4 6, Phase 3 10, Phase 2 7, Phase 1/2 1, Phase 1 11) 2022: 61 trials (Other 1, Observational 11, Not applicable 14, Phase 4 10, Phase 3 4, Phase 2 8, Phase 1/2 2, Phase 1 11) 2023: 56 trials (Observational 10, Not applicable 13, Phase 4 8, Phase 3 2, Phase 2/3 2, Phase 2 4, Phase 1/2 4, Phase 1 13) 2024: 46 trials (Observational 7, Not applicable 11, Phase 4 7, Phase 3 8, Phase 2/3 1, Phase 2 5, Phase 1/2 1, Phase 1 6) 2025: 44 trials (Observational 7, Not applicable 8, Phase 4 8, Phase 3 3, Phase 2 5, Phase 1/2 2, Phase 1 11)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 38
2025 44
2024 46
2023 56
2022 61
2021 72
2020 50
2019 48
2018 54
2017 40

Showing 10 of 32 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 46 trials starting in 2026 and about 41 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 35 months from start to primary completion across 61 trials still running at the 2026-10-09 snapshot; registered median of 16 months across 986 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Malaria trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 263
Phase 1/2 70
Phase 2 141
Phase 2/3 35
Phase 3 171
Phase 4 202
Not applicable 271
Observational 222
Unknown 1

How many Malaria trials are recruiting? (9)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 35
Recruiting 56
Enrolling by invitation 2
Active, not recruiting 28
Completed 1,032

Showing 5 of 9 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Malaria trials? (6)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 120
GlaxoSmithKline 51
U.S. Army Medical Research and Development Command 37
Centers for Disease Control and Prevention 36
Sanaria Inc. 29

Showing 5 of 6 sponsors.

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Which drugs are being tested for Malaria? (5)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Chloroquine 67
Primaquine 67
Tafenoquine 26
Coartem 21
Amodiaquine 17

Interventions as named in the registry (10)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
1. Artemether-Lumefantrine (AL) 89
Dihydroartemisinine-Piperaquine 81
Pyrimethamine/sulfadoxine 47
Artesunate 38
PfSPZ (7G8) Challenge 28

Showing 5 of 10 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Malaria trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Malaria 1,961 27
Pneumonia 1,653 27
Gastroenteritis 1,348 22
Anaemia 1,040 17
Febrile convulsion 970 14

Showing 5 of 10 adverse events.

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Which publications cover Malaria? (1,195)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Effectiveness of the RTS,S/AS01<sub>E</sub> malaria vaccine in a real-world setting over 1 year of follow-up after the three-dose primary schedule: an interim analysis of a phase 4 study in Ghana, Kenya, and Malawi. The Lancet. Global health 2026 Yes
Naturally acquired immune responses to alpha-gal in malaria endemic settings and pre-clinical efficacy testing with R21/MM. Vaccine 2025 Yes
Effect of a spatial repellent on malaria incidence in an area of western Kenya characterised by high malaria transmission, insecticide resistance, and universal coverage of insecticide treated nets (part of the AEGIS Consortium): a cluster-randomised, controlled trial. Lancet (London, England) 2025 Yes
Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials. The Lancet. Microbe 2025 Yes
Experiences, perceptions and ethical considerations of the malaria infection study in Thailand. BMC medical ethics 2025 Yes

Showing 5 of 1,195 publications.

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Prevalence (93)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Malaria Annual incidence 1-9 / 100 000 United Kingdom GB Unspecified
Malaria Annual incidence 1-9 / 100 000 United Kingdom GB Exact
Malaria Annual incidence 1-9 / 100 000 United Kingdom GB Exact
Malaria Annual incidence 1-9 / 1 000 000 Slovenia Not stated Exact
Malaria Annual incidence 1-9 / 100 000 Ireland Not stated Exact

Showing 5 of 93 prevalence observations.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Malaria 673 Exact Orphadata Science knowledge files, Product 1
Malaria 673 Exact Orphanet Rare Disease Ontology (ORDO)

Sub-conditions in MeSH (3)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

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