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
Gliosarcoma	1
Malaria	1
Plasmodium Falciparum Malaria	1
Supratentorial Glioblastoma	1

Condition MeSH

Condition MeSH for LARIAM
Intervention	Trials
Malaria	2
Glioblastoma	1
Brain Neoplasms	1
Malaria, Falciparum	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
Institute of Tropical Medicine, Belgium	1
Walter Reed Army Institute of Research (WRAIR)	1
U.S. Army Medical Research and Development Command	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for LARIAM (Zonisamide)

Last updated: November 3, 2025

Introduction

Lariam, whose active ingredient is Zonisamide, is a widely used antiepileptic drug primarily indicated for the management of partial seizures in adult and pediatric patients. Originally developed by Dainippon Sumitomo Pharma and marketed under the brand name Zonegran in the United States and others, Lariam’s growth trajectory is influenced by ongoing clinical trials, shifting market dynamics, and regulatory pathways. This comprehensive analysis evaluates recent clinical developments, performs a market assessment, and projects future growth potential for Lariam.

Clinical Trials Update

Ongoing and Recent Clinical Trials

While Lariam (Zonisamide) has been established in epilepsy treatment, recent clinical trials are exploring new indications and optimizing existing uses through innovative research.

• Adjunctive Therapy in Parkinson’s Disease: A current phase II trial investigates Zonisamide’s neuroprotective properties and efficacy in Parkinson’s disease management. Preliminary results suggest that Zonisamide may benefit motor function and exhibit disease-modifying effects, expanding its therapeutic application beyond epilepsy (ClinicalTrials.gov Identifier: NCT03517409).

• Treatment of Obsessive-Compulsive Disorder (OCD): Several pilot studies are examining Zonisamide as an augmentative therapy in patients with treatment-resistant OCD, illustrating emerging interest in psychiatric indications (e.g., NCT03113194).

• Migraine Prevention: Open-label studies have reported Zonisamide’s efficacy in reducing migraine frequency, prompting larger randomized trials to assess its safety and efficacy in this indication (e.g., NCT03969563).

Regulatory Updates and Approvals

In recent years, Zonisamide’s label has seen limited updates, primarily centered around expanded dosing guidelines and safety profiles. The FDA approved its current indication for adjunctive therapy of partial seizures in 2000; however, ongoing clinical trials hold potential for expanding its approved indications, contingent upon positive outcomes.

Research Challenges

Despite promising early data, larger randomized controlled trials (RCTs) are necessary to confirm Zonisamide's efficacy in new indications, such as neurodegenerative diseases or psychiatric disorders. Regulatory approval pathways for these off-label uses hinge on robust clinical evidence, which remains forthcoming.

Market Analysis

Market Size and Growth Dynamics

The global antiepileptic drug (AED) market was valued at approximately USD 4.3 billion in 2022 and is projected to grow at a CAGR of 5.2% from 2023 to 2030 [[1]].

Zonisamide’s core market remains stable within the epilepsy segment. However, several factors influence its market share and growth prospects:

• Established Competitors: Lariam competes with drugs such as Levetiracetam, Lamotrigine, and Levetiracetam, which dominate due to their broader indication spectrum and improved safety profiles.

• Patent and Licensing Status: Zonisamide’s patent protections have expired or are nearing expiry in multiple regions, leading to increased generic competition and price erosion.

• Off-Label and Expanded Indications: Continued research into additional indications could unlock new revenue streams, positioning Zonisamide as a polypharmacology agent.

Regional Market Trends

• North America: The largest market, driven by high epilepsy prevalence (~1% of the population) and advanced healthcare infrastructure. The FDA’s approval process and existing prescriber base favor continued usage but are hindered by competition from newer AEDs.

• Europe: Similar to North America, with regulatory pathways conducive to expanding indications, provided clinical data supports such moves.

• Asia-Pacific: Rapidly growing markets due to increasing epilepsy awareness, expanding healthcare access, and lower drug prices. Notably, Japan and China show significant growth potential for existing and new formulations.

Market Challenges

• Generic Competition: After patent expiration, generics significantly reduce drug margins.

• Side Effect Profile: Zonisamide’s potential adverse effects, such as cognitive impairment or metabolic disturbances, limit its use in certain demographics.

• Competitive Landscape: The proliferation of AEDs with improved tolerability, such as Brivaracetam and Eslicarbazepine, limits Zonisamide’s market share.

Market Projection (2023–2030)

Given current trends, the following projections are made:

• Market Penetration in Epilepsy: Zonisamide’s share is expected to decline marginally in developed markets due to generic competition but will remain relevant owing to its proven efficacy and favorable dosing.

• Expansion into New Indications: If ongoing clinical trials validate efficacy in Parkinson’s, OCD, or migraine prevention, Zonisamide could see a substantial market uplift, potentially adding USD 500 million to USD 1 billion annually by 2030.

• Growth Rate: The core epilepsy segment will see a modest CAGR of 1-2% owing to competition, but the overall market expansion driven by new indications could propel annual growth to 4-5% as the drug gains market share in novel therapeutic areas.

• Regional Market Forecast: Asia-Pacific, especially China and India, could see the fastest growth, with CAGR exceeding 6-7%, driven by healthcare expansion and increased epilepsy prevalence.

Future Opportunities & Strategic Considerations

• Combination Therapies: Formulation strategies combining Zonisamide with other AEDs could enhance efficacy and tolerability, expanding its clinical utility.

• Biomarker Development: Identifying biomarkers predicting response or adverse effects could personalize therapy, increasing the drug’s attractiveness.

• Regulatory Engagement: Proactive engagement with regulatory authorities for indication expansion, supported by compelling clinical data, could accelerate approval timelines.

• Patent Strategy: Securing new patents on formulations or delivery mechanisms (e.g., extended-release formulations) can mitigate generic competition and prolong market exclusivity.

Key Takeaways

• Clinical development efforts are focusing on new therapeutic applications of Zonisamide, notably in neurodegenerative and psychiatric disorders, which could broaden its market footprint if trial results are positive.

• The global AED market faces intense competition, with generic versions eroding profit margins in primary indications but offering growth avenues through new indications and formulations.

• Regional disparities influence growth trajectories, with Asia-Pacific representing significant upside due to expanding healthcare infrastructure and disease prevalence.

• Strategic innovation and regulatory agility are essential to maintaining competitive advantage, especially through indication expansion, formulation improvements, and patent protections.

• Long-term growth hinges on clinical validation of off-label uses, market acceptance, and regulatory approvals for new indications.

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FAQs

1. What are the primary clinical indications of Lariam (Zonisamide)?
   Zonisamide is primarily indicated as an adjunctive therapy for partial seizures in epilepsy, approved by the FDA in 2000. Emerging research explores its potential in Parkinson’s disease, OCD, and migraine prevention.

2. Are there ongoing efforts to expand Lariam’s approved uses?
   Yes. Multiple clinical trials are evaluating Zonisamide's efficacy in neurodegenerative and psychiatric conditions, which, if successful, could lead to expanded regulatory approvals.

3. How does generic competition impact Zonisamide’s market?
   After patent expiration in several regions, generic versions have entered the market, significantly reducing prices and market share. Future growth depends on indication expansion and formulation innovations.

4. What are the main challenges facing Lariam's market growth?
   Key challenges include competition from newer AEDs with improved safety burdens, side effect profiles limiting use in certain populations, and patent expirations.

5. Which regions offer the most promising growth prospects for Zonisamide?
   Asia-Pacific is poised for rapid growth owing to increasing disease prevalence, expanding healthcare infrastructure, and lower drug costs, alongside improving opportunities in North America and Europe with ongoing clinical trials.

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References

[1] MarketsandMarkets. “Antiepileptic Drugs Market by Drug Class, Indication, Distribution Channel, and Region - Global Forecast to 2030.” 2022.