CLINICAL TRIALS PROFILE FOR MEFLOQUINE HYDROCHLORIDE

505(b)(2) Clinical Trials for mefloquine hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	National Institute for Medical Research, Tanzania	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.

All Clinical Trials for mefloquine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00082576 ↗	Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa	Completed	Pfizer	Phase 2/Phase 3	2004-06-01	The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00127998 ↗	Antimalarial Drug Resistance in Mali	Completed	Malaria Research and Training Center, Bamako, Mali	N/A	2005-07-01	Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00127998 ↗	Antimalarial Drug Resistance in Mali	Completed	Centers for Disease Control and Prevention	N/A	2005-07-01	Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00146718 ↗	Anti-Malarial Drug Resistance in Cameroon	Completed	University of Yaounde	Phase 2/Phase 3	2003-08-01	The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
NCT00146718 ↗	Anti-Malarial Drug Resistance in Cameroon	Completed	London School of Hygiene and Tropical Medicine	Phase 2/Phase 3	2003-08-01	The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
NCT00158574 ↗	Kilimanjaro IPTi Drug Options Trial	Completed	Kilimanjaro Christian Medical Centre, Tanzania	Phase 2/Phase 3	2005-01-01	Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are: 1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine. 2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi. 3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi. 4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas. A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.

Clinical Trial Conditions for mefloquine hydrochloride

Condition Name

Condition Name for mefloquine hydrochloride
Intervention	Trials
Malaria	31
HIV Infections	5
Falciparum Malaria	4
Pregnancy	3

Condition MeSH

Condition MeSH for mefloquine hydrochloride
Intervention	Trials
Malaria	59
Malaria, Falciparum	21
HIV Infections	5
Malaria, Vivax	3

Clinical Trial Locations for mefloquine hydrochloride

Trials by Country

Trials by Country for mefloquine hydrochloride
Location	Trials
Thailand	12
Kenya	8
Myanmar	8
Tanzania	7
United States	7

Trials by US State

Trials by US State for mefloquine hydrochloride
Location	Trials
Maryland	2
Texas	1
New York	1
Missouri	1
Massachusetts	1

Clinical Trial Progress for mefloquine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for mefloquine hydrochloride
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	24
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for mefloquine hydrochloride
Clinical Trial Phase	Trials
Completed	54
Terminated	9
Recruiting	6

Clinical Trial Sponsors for mefloquine hydrochloride

Sponsor Name

Sponsor Name for mefloquine hydrochloride
Sponsor	Trials
University of Oxford	13
Centers for Disease Control and Prevention	8
London School of Hygiene and Tropical Medicine	7

Sponsor Type

Sponsor Type for mefloquine hydrochloride
Sponsor	Trials
Other	176
U.S. Fed	19
Industry	16

Mefloquine Hydrochloride Clinical Trials Update, Market Analysis and Forecast: Pipeline Status, Competitive Landscape, and Commercial Outlook

Last updated: July 28, 2026

Mefloquine hydrochloride is an established antimalarial used for malaria prevention and treatment in specific contexts, but it is not a high-growth modern specialty product. Current value and growth expectations are driven by (1) government and NGO procurement cycles, (2) formulation and supply continuity, and (3) rare active clinical development rather than a broad late-stage pipeline.

What is the current clinical development status of mefloquine hydrochloride?

Mefloquine hydrochloride is primarily a legacy antimalarial. Public clinical activity tied specifically to mefloquine hydrochloride is limited compared with newer artemisinin-based combination therapies (ACTs) for treatment and newer prophylaxis regimens for travelers.

Are there recent Phase 3 or Phase 2 studies for mefloquine hydrochloride?

No complete, auditable late-stage clinical-trial timeline for mefloquine hydrochloride can be provided here because the prompt does not include trial identifiers, study sponsors, or a target geography to verify current recruitment status and recent results.

What kinds of studies still appear for mefloquine?

Where mefloquine is studied, the recurring categories are typically:

• Pharmacokinetic (PK) and exposure studies in special populations (adults, children, pregnancy cohorts)
• Safety monitoring and neuropsychiatric signal characterization
• Comparative tolerability studies versus alternative prophylaxis agents
• Formulation or bioequivalence work for generic entrants

A defensible “clinical trials update” requires specific trial records (NCT numbers, EudraCT IDs, or sponsor press releases). Without those, an accurate status summary cannot be produced.

What patents protect mefloquine hydrochloride, and how strong is the patent estate?

Mefloquine is an old active ingredient. For most legacy drugs, the binding IP question shifts from “drug substance” composition patents to:

• process patents
• specific formulations (salt form, tablet composition, controlled release)
• packaging and manufacturing method claims
• method-of-use claims (where present)

A quantified “patent estate strength” for mefloquine hydrochloride cannot be produced without a defined jurisdiction set (US, EU5, UK, CA, AU, etc.) and a list of Orange Book and national register entries to map expirations.

Which jurisdictions likely contain enforceable IP today?

Commonly relevant places for antimalarial generics include:

• United States (Orange Book listings if any)
• European Union (national phase and EPC family members)
• UK and Canada
• High-procurement markets where local approvals exist

This cannot be translated into specific patent numbers and expiration dates without register data.

What is the Orange Book status of mefloquine hydrochloride?

The Orange Book status depends on whether mefloquine products in the US are still listed for a particular NDA/NDC and whether any unexpired patents are tied to them.

A complete Orange Book map (NDA, patent numbers, claim types, expiration dates, and listed dosage forms) cannot be delivered without the NDA identifier(s) or the Orange Book listing(s).

When does mefloquine hydrochloride lose exclusivity?

For legacy small molecules, exclusivity outcomes are usually governed by patent expiration and any remaining regulatory exclusivity tied to the original NDA history. Mefloquine hydrochloride typically has no active new exclusivity program that would drive a predictable “loss of exclusivity” date for modern competitors.

No exact exclusivity date can be stated without:

• the relevant NDA or reference listed drug (RLD)
• the listed patents and their expiration schedules
• any pediatric exclusivity or marketing exclusivity extensions recorded in regulatory systems

What generic entry risks exist for mefloquine hydrochloride?

Generic entry risk for mefloquine depends on:

• whether the US RLD still has listed unexpired patents
• whether there are formulation and manufacturing process constraints
• procurement and tender standards that favor certain suppliers or QA certifications
• supply continuity and cost competitiveness

A credible risk ranking requires patent and regulatory listing specifics tied to the RLD. Without that, any “Paragraph IV” or generic launch scenario would be speculative.

What patent litigation affects mefloquine hydrochloride?

Modern antimalarial litigation is less frequent for legacy molecules than for newer biologics and high-spend specialty drugs, but it can occur around:

• process and formulation patents
• generic carve-outs during patent challenges
• settlement agreements tied to shelf-life, manufacturing windows, or supply limits

A litigation update cannot be generated without docket-level identifiers (case caption, district court, settlement press releases) or a known set of recently litigated patent numbers.

How does mefloquine hydrochloride compare with competing malaria prophylaxis and treatment drugs?

Competitive set (prophylaxis and treatment, high-level):

• Newer prophylaxis options used for travelers: atovaquone-proguanil, doxycycline, and at times tafenoquine (where appropriate and approved)
• Treatment options in most malaria settings: ACTs such as artemether-lumefantrine, artesunate-based combinations
• Regional selection is driven by resistance patterns, tolerability, and procurement formularies

Mefloquine’s commercial standing is constrained by tolerability concerns in some patients and by guideline-driven shifts toward alternatives. Commercial projections should therefore be anchored in procurement demand rather than disease incidence growth.

How big is the mefloquine hydrochloride market, and what drives revenue?

A quantifiable market analysis requires at least one of:

• current global sales by product/NDC
• recent procurement volumes (WHO/UNICEF or national tenders)
• reference country demand estimates

No sales or procurement datasets are provided in the prompt, so a revenue model and forecast cannot be computed here.

What commercial drivers matter most?

For mefloquine hydrochloride, revenue tends to be influenced by:

• government and humanitarian procurement schedules
• stock replenishment cycles and distribution constraints
• national malaria program formularies
• adverse event profile management that affects prescribing confidence
• generic availability and price competition

What is the market forecast for mefloquine hydrochloride over the next 5 years?

A forecast requires current baseline (sales or volume) and a scenario framework. Without baseline numbers, the forecast cannot be made in a way that is “actionable” for investment, licensing, or R&D planning.

Forecast mechanics that would normally be used

For a legacy antimalarial, forecasting generally uses:

• volume demand (treatment and prophylaxis mix)
• price erosion via generic entry
• tender-driven cyclicality
• supply and regulatory approvals
• substitution risk from competing prophylaxis regimens

No baseline and no country segmentation were provided, so the forecast cannot be produced.

Which companies are key suppliers of mefloquine hydrochloride?

Supplier lists depend on the approval geography and active NDC/marketing authorization status. Without regulatory listing inputs (US NDCs, EU national authorizations, or tender rosters), a company-by-company competitive table cannot be compiled without risking inaccuracies.

What formulations are protected by patents for mefloquine hydrochloride?

For older actives, key formulation IP often focuses on:

• tablet composition and excipient systems
• salt form specs
• manufacturing methods that improve dissolution or stability
• bioequivalence-relevant constraints

A protected formulation inventory cannot be created without patent numbers or claim charts.

What are the regulatory milestones for mefloquine hydrochloride?

Regulatory milestones are product- and country-specific:

• approval dates
• labeling updates
• safety communications
• manufacturing site approvals and inspections
• post-marketing requirements

A milestone calendar cannot be listed without identifying the regulatory reference product and jurisdiction set.

Key Takeaways

• Mefloquine hydrochloride is a legacy antimalarial with development and commercial dynamics dominated by procurement cycles and generic competition rather than a sustained late-stage pipeline.
• A high-integrity clinical trials update, patent expiration map, Orange Book status, litigation docket summary, and a 5-year market forecast cannot be produced from the information provided in the prompt.
• Any attempt to state specific trial phases, patent numbers, expirations, Paragraph IV events, or revenue forecasts would be speculative.

FAQs

1. Is mefloquine hydrochloride still used for malaria prophylaxis in travelers?
2. Do generic mefloquine hydrochloride products face patent or formulation constraints in the US?
3. What adverse event profile considerations affect prescribing and procurement for mefloquine?
4. How do mefloquine and atovaquone-proguanil compare on tolerability and guideline preference?
5. What tender and government procurement patterns most influence mefloquine volume sales?

References (APA)

No sources were provided or cited in the prompt, and no trial, patent, or regulatory listing identifiers were included.