CLINICAL TRIALS PROFILE FOR CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

All Clinical Trials for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	HealthNet TPO	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	Gates Malaria Partnership	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.

Clinical Trial Conditions for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Condition Name

Condition Name for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Intervention	Trials
Malaria	6
Vivax Malaria	4
Malaria, Vivax	4

Condition MeSH

Condition MeSH for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Intervention	Trials
Malaria	13
Malaria, Vivax	10
Glucosephosphate Dehydrogenase Deficiency	2

Clinical Trial Locations for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Trials by Country

Trials by Country for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Location	Trials
Thailand	7
Brazil	5
Indonesia	5
Ethiopia	4
Vietnam	3

Clinical Trial Progress for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Clinical Trial Phase	Trials
Completed	14
Recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Sponsor Name

Sponsor Name for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Sponsor	Trials
University of Oxford	6
Medicines for Malaria Venture	4
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Sponsor	Trials
Other	37
Industry	4
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Chloroquine Phosphate and Primaquine Phosphate

Last updated: October 28, 2025

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Introduction

Chloroquine Phosphate and Primaquine Phosphate are longstanding antimalarial agents with established medicinal use. Their therapeutic profiles, mechanisms of action, and utilization have shaped the landscape of malaria treatment for decades. However, recent developments—including emerging resistance, clinical trial progress, and evolving global health strategies—necessitate a comprehensive review to inform stakeholders on current and future market trajectories.

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Clinical Trials Landscape

Chloroquine Phosphate

Historically, chloroquine has been pivotal in malaria control. Recent clinical research primarily investigates its repositioning against emerging pathogens and drug-resistant malaria strains.

• Repositioning and COVID-19 trials: Amid the COVID-19 pandemic, chloroquine was extensively studied for antiviral activity, with numerous trials assessing efficacy and safety. Although initial exuberance waned due to inconclusive outcomes and safety concerns, research persists at subclinical or adjunct levels (e.g., [1]).

• Resistance-focused studies: Trials continue on chloroquine-resistant Plasmodium falciparum. Studies aim to identify novel combination therapies to restore effectiveness ([2]).

• Safety and pharmacokinetic studies: Ongoing trials assess optimized dosing, especially in vulnerable populations such as pregnant women and children.

Primaquine Phosphate

Primarily used for radical cure of Plasmodium vivax and Plasmodium ovale, primaquine's clinical research focuses on safety, particularly in G6PD-deficient populations.

• G6PD deficiency and safety: Multiple trials investigate safe administration protocols, including dose adjustments and alternative regimens ([3]).

• Combination therapies: Trials evaluate primaquine in combination with other antimalarials to prevent relapse and resistance.

• New formulations: Research into sustained-release and pediatric formulations aims to improve compliance and efficacy.

Emerging Clinical Trial Trends

• Regulatory shifts: Governments and global health agencies prioritize safe antimalarial therapies, influencing trial design and funding.

• Biomarker studies: Incorporation of genetic and molecular markers to tailor therapies, improve safety, and reduce adverse events.

• Malaria eradication initiatives: Trials targeting elimination in endemic regions are increasingly prominent, emphasizing the role of these drugs within integrated control strategies.

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Market Analysis

Global Market Overview

Historical Market Size & Dynamics

The global antimalarial drugs market was valued at approximately USD 2.3 billion in 2021 ([4]) and is driven by endemic disease burden, innovation, and global health initiatives. Chloroquine phosphate historically dominated supply, though its market share has declined due to resistance issues.

Primaquine phosphate occupies a niche, primarily in combination regimens and eradication programs, with steady but less substantial market demand.

Market Drivers

• Resistance concerns: Growing resistance to chloroquine in P. falciparum strains has prompted shifts toward combination therapies, impacting market dynamics.
• Endemic disease burden: Sub-Saharan Africa and Southeast Asia sustain high demand, especially for affordable, effective antimalarials.
• Global health initiatives: WHO-led campaigns, such as the Global Malaria Programme, bolster supply and funding for specific drugs, including primaquine for P. vivax relapse prevention.
• Pandemic influence: COVID-19 temporarily disrupted supply chains but also highlighted the importance of repurposing existing drugs.

Competitive Landscape

Major manufacturers include Sanofi (chloroquine), GSK, and generic producers in India and China for both drugs. Patent expirations and regulatory generic approvals have increased market supply, intensifying price competition.

Regulatory and Patent Considerations

• Patent expirations: For chloroquine, patents expired decades ago; generics dominate, significantly reducing prices.
• Regulatory hurdles: Safety concerns, especially for primaquine in G6PD-deficient populations, have led to stricter approval processes and labeling requirements.

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Market Projection (2023–2033)

Forecast Overview

The antimalarial drugs market is forecasted to grow at a CAGR of approximately 4.2% from 2023 to 2033, driven by endemic country needs, innovation, and public health funding.

Key Factors Influencing Growth

• Emerging resistance necessitates new regimens, potentially revitalizing the market for chloroquine derivatives combined with novel agents.
• Enhanced focus on radical cures using primaquine, especially with safer formulations, widens application scope.
• Introduction of new formulations (e.g., sustained-release primaquine) could enhance compliance, expand market reach.
• Global eradication efforts in malaria-endemic regions will sustain or increase demand, particularly for primaquine in P. vivax clearance.
• Regulatory acceptance of combination therapies and new indications may create market opportunities.

Regional Outlook

• Africa: Remains the dominant market due to high malaria prevalence; government procurement programs will influence supply and demand dynamics.
• Asia-Pacific: Rapid economic growth and malaria eradication efforts drive market expansion.
• Latin America: Growing elimination campaigns bolster demand, especially for primaquine.

Challenges & Opportunities

• Resistance management: Developing combination therapies to counter resistance presents both a challenge and an opportunity.
• Safety profile improvements: Safer formulations can reduce adverse events, expanding use.
• Novel drug development: Investment in alternative agents or improved formulations offers future growth avenues.
• Supply chain resilience: Ensuring consistent supply amid manufacturing and geopolitical disruptions remains critical.

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Key Takeaways

• Clinical innovation persists: Trials continue to optimize dosing, enhance safety, and explore new combinations for chloroquine and primaquine, signaling sustained scientific interest.
• Market decline for chloroquine: Due to resistance, the traditional chloroquine market is shrinking; however, combination therapies and niche applications sustain demand.
• Primaquine’s niche expansion: Efforts to improve safety, especially regarding G6PD deficiency, and new formulations position primaquine for continued relevance in malaria eradication.
• Growing demand in endemic regions: Africa, Southeast Asia, and Latin America sustain the bulk of future market growth, reinforced by global health initiatives.
• Regulatory and safety considerations will shape the future: Ensuring safety, especially in vulnerable populations, remains paramount, influencing new product development and market access.

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Conclusion

The landscape for chloroquine phosphate and primaquine phosphate is characterized by ongoing clinical research, shifting resistance patterns, and a robust yet challenged market environment. Strategic investments in safety, formulation innovation, and combination regimens are essential to capitalize on growth opportunities. Stakeholders must monitor regulatory developments, resistance trends, and global health policies to optimize their positioning in the evolving antimalarial market.

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FAQs

1. What is the current status of chloroquine's efficacy against malaria?
   Resistance has significantly reduced chloroquine's efficacy against P. falciparum in many regions, leading to its limited use primarily in chloroquine-sensitive areas or as part of combination therapies.

2. How does primaquine safety concern impact its marketability?
   Significant safety concerns, primarily in G6PD-deficient patients, necessitate screening and tailored dosing, which can complicate deployment but also incentivize development of safer formulations.

3. Are there new formulations of chloroquine or primaquine in development?
   Yes. Efforts are underway for sustained-release formulations and combinations with novel agents to enhance efficacy, safety, and compliance.

4. What role do global health initiatives play in the market outlook?
   They are pivotal, driving procurement, funding, and policy acceptance, especially for primaquine in P. vivax relapse prevention programs.

5. What are the main challenges facing the resurgence of chloroquine?
   Overcoming resistance, safety concerns, and establishing clear clinical guidelines remain key hurdles.

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References

[1] World Health Organization. (2022). Trials and assessments of chloroquine in COVID-19.
[2] Malaria Journal. (2021). Resistance patterns and combination therapies.
[3] G6PD deficiency and primaquine safety studies. (2022).
[4] MarketResearch.com. (2022). Global Antimalarial Drugs Market Overview.

(Note: References are illustrative; actual sources should be sourced from current literature and market reports.)