CLINICAL TRIALS PROFILE FOR LARIAM

All Clinical Trials for LARIAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Centre Muraz	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Liverpool School of Tropical Medicine	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Institute of Tropical Medicine, Belgium	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00761020 ↗	Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection	Completed	Walter Reed Army Institute of Research (WRAIR)	N/A	2008-09-01	The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.

Clinical Trial Conditions for LARIAM

Condition Name

Condition Name for LARIAM
Intervention	Trials
Brain Cancer	1
Glioblastoma	1
Gliosarcoma	1
Malaria	1

Condition MeSH

Condition MeSH for LARIAM
Intervention	Trials
Malaria	2
Infections	1
Infection	1
Gliosarcoma	1

Clinical Trial Locations for LARIAM

Trials by Country

Trials by Country for LARIAM
Location	Trials
United States	2
Burkina Faso	1

Trials by US State

Trials by US State for LARIAM
Location	Trials
Texas	1
Maryland	1

Clinical Trial Progress for LARIAM

Clinical Trial Phase

Clinical Trial Phase for LARIAM
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LARIAM
Clinical Trial Phase	Trials
Completed	2
Active, not recruiting	1

Clinical Trial Sponsors for LARIAM

Sponsor Name

Sponsor Name for LARIAM
Sponsor	Trials
Centre Muraz	1
Liverpool School of Tropical Medicine	1
Institute of Tropical Medicine, Belgium	1

Sponsor Type

Sponsor Type for LARIAM
Sponsor	Trials
Other	4
U.S. Fed	2
NIH	1

Last updated: May 5, 2026

LARIAM (Mefloquine): Clinical Trials Update, Market Analysis and Projection

What is LARIAM and what does its clinical evidence base look like?

LARIAM is the brand name for mefloquine (mefloquine hydrochloride), an oral antimalarial used for malaria prophylaxis and treatment of acute uncomplicated malaria. The product’s clinical development footprint is older than modern regulatory-era registries, so most “updates” in practice show up as new guideline positions, safety labeling revisions, and comparative effectiveness literature rather than new late-stage trials.

Clinical trials update (latest signal by evidence stream)

• No new, company-sponsored Phase 3 program is identifiable for LARIAM in the modern era from the major global trial registries and regulatory labeling records that would materially shift current indications.
• The dominant post-approval evidence stream is:
  • Guideline updates on prophylaxis and treatment choices (often positioning mefloquine relative to doxycycline and atovaquone-proguanil).
  • Pharmacovigilance/safety reviews that reinforce existing boxed or prominent neuropsychiatric cautions in many jurisdictions.
  • Operational effectiveness studies in endemic regions, typically focusing on adherence and adverse-event profiles rather than novel dosing regimens.

Core clinical evidence used historically for authorization

Most regulatory approvals relied on:

• Randomized controlled trials comparing mefloquine to other antimalarials for treatment and prophylaxis.
• Studies supporting standard dosing regimens (including prophylaxis schedules) and comparative outcomes including parasitological clearance and tolerability.

Safety and labeling constraints that shape clinical uptake

LARIAM’s market access and clinical use are constrained by safety considerations that affect prescriber willingness and patient adherence:

• Neuropsychiatric adverse effects are the principal driver of restrictive use and contraindication language in many labeling versions.
• Contraindications and warnings often limit use in individuals with certain psychiatric or seizure risk profiles and trigger heightened monitoring or alternative prophylaxis selection.
• Drug-administration compliance matters because prophylaxis requires steady adherence; mefloquine’s dosing schedule can be convenient, but tolerability issues can reduce continuation.

What is the current market reality for LARIAM?

The market for mefloquine is shaped by a structural shift in travel and malaria prophylaxis away from mefloquine toward alternatives with different safety/tolerability profiles (notably doxycycline and atovaquone-proguanil, with regional variation). LARIAM remains present, but its addressable demand is narrower than at peak periods of usage.

Demand drivers

• Travel prophylaxis: demand is sensitive to travel volumes and airline/tourism patterns, but also sensitive to prescribing preferences and guideline language about neuropsychiatric risk.
• Public health procurement: mefloquine use persists in some contexts where it is stocked or where resistance patterns and formularies favor it.
• Indication scope: in many countries, mefloquine sits alongside other oral antimalarials; its role depends on local resistance and guideline recommendations.

Supply and competitive set

• LARIAM is in a crowded antimalarial space where multiple generics and branded therapies exist.
• Competitive pressure tends to be strongest where alternatives are preferred due to safety profile and ease of use.

What does market projection for LARIAM look like?

Given the lack of modern late-stage evidence that would expand indications or materially broaden use, projections are anchored to:

1. Maintenance of existing market share in regions and segments where mefloquine remains guideline-supported or formulary-stocked.
2. Pressure from guideline-driven prophylaxis substitution toward other agents.
3. Attrition from safety-driven prescribing restrictions for travel medicine and outpatient settings.

Market projection framework (directional)

• Revenue trajectory: stable-to-declining over the medium term in markets where alternatives have displaced mefloquine for routine prophylaxis.
• Volume trajectory: stable in procurement-heavy geographies with existing stock and where resistance profiles make mefloquine practical; lower growth outside those settings.
• Upside scenarios require new expansions (new formulations, new indications, or major safety re-positioning), which are not evidenced by a recent late-stage clinical development signal.

Clinical development and trial activity: what are the practical implications for timelines?

Because mefloquine’s development is mature, the key near-term “update” risk is not discovery, it is:

• Regulatory and label evolution as safety data accumulate.
• Formulary inclusion decisions by national programs and large travel clinics.
• Resistance management in malaria-endemic regions, which can either sustain or reduce role in treatment algorithms.

Investment and R&D read-through

For business planning, the LARIAM thesis is typically not “growth via new clinical breakthrough.” It is:

• Brand/generic-managed portfolio economics in a mature antimalarial class.
• Margin and supply-chain execution in regions where procurement continues.
• Risk management around neuropsychiatric safety language and use restrictions.

Key market-relevant constraints (what can cap demand)

• Psychiatric and neurologic safety perception reduces willingness to prescribe for routine travel prophylaxis.
• Preference drift: travel medicine prescribing increasingly selects alternatives when guidelines allow.
• Public sector procurement patterns: mefloquine use depends on national protocols and available alternatives.

What segments likely remain most material?

• Geographies with established mefloquine procurement under national malaria control programs.
• Travel populations in which mefloquine remains a guideline-supported or last-line option due to local resistance patterns and alternative availability.
• Settings where formularies already include mefloquine and where switching would create administrative and clinical continuity costs.

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Key Takeaways

• LARIAM (mefloquine) has a mature, older clinical evidence base; current “updates” are mostly safety labeling, guideline positioning, and comparative/operational studies, not new late-stage trials.
• Market demand is structurally constrained by neuropsychiatric safety warnings and by prescribing preference drift toward alternatives such as doxycycline and atovaquone-proguanil for prophylaxis.
• Projection direction is stable-to-declining in many mature travel markets, with more durability where public procurement and formularies continue to support mefloquine use.
• The path to meaningful upside would require new regimen/formulation differentiation or guideline re-positioning, which is not indicated by a modern late-stage trial expansion signal.

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FAQs

1) Is LARIAM still used for malaria prophylaxis?
Yes. LARIAM is used for malaria prophylaxis in settings where it remains guideline-supported and where prescriber and patient risk screening allow.

2) What limits LARIAM adoption most strongly?
Neuropsychiatric adverse effects and the resulting safety warnings and use restrictions reduce routine travel prophylaxis uptake.

3) Are there new Phase 3 trials for LARIAM?
No clear new Phase 3 expansion signal is evident in modern registries from the standpoint of producing a material indication-expanding shift.

4) How does resistance affect LARIAM’s market role?
Local resistance patterns influence whether mefloquine appears in treatment algorithms and whether it is stocked for procurement.

5) What alternatives compete directly with LARIAM?
Doxycycline and atovaquone-proguanil for prophylaxis, plus other oral antimalarials for treatment depending on country resistance and guideline recommendations.

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References

[1] U.S. Food and Drug Administration. Lariam (mefloquine hydrochloride) label / prescribing information.
[2] European Medicines Agency (EMA). Assessment history and product information for mefloquine-containing medicinal products (Lariam and/or authorized mefloquine products).
[3] World Health Organization (WHO). Malaria guidelines and recommendations on antimalarial prophylaxis and treatment (updates and technical guidance documents).
[4] CDC. Malaria prophylaxis guidance and antimalarial use recommendations (mefloquine positioning relative to alternatives).
[5] International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. Searches for “mefloquine” and “Lariam” clinical trial activity and study status.