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
NCT01205178 ↗	G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)	Completed	Medicines for Malaria Venture	Phase 1	2009-07-02	SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days. The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
NCT00440999 ↗	Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria	Completed	Shin Poong Pharmaceuticals	Phase 3	2007-03-01	The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
NCT00440999 ↗	Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria	Completed	Medicines for Malaria Venture	Phase 3	2007-03-01	The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
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
Malaria, Vivax	4
Vivax Malaria	4
Healthy	3

Condition MeSH

Condition MeSH for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Intervention	Trials
Malaria	13
Malaria, Vivax	10
Glucosephosphate Dehydrogenase Deficiency	2
Neoplasm Metastasis	1

Clinical Trial Locations for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

Trials by Country

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Trials by Country for CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
Location	Trials
Thailand	7
Indonesia	5
Brazil	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
Not yet recruiting	1
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

Chloroquine Phosphate and Primaquine Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction

Chloroquine phosphate and primaquine phosphate are antimalarial drugs that have garnered significant attention in recent years, particularly during the COVID-19 pandemic and in the ongoing fight against malaria. This article delves into the current state of clinical trials, market analysis, and future projections for these drugs.

Clinical Trials Update for Chloroquine Phosphate

COVID-19 Treatment

Chloroquine phosphate has been explored as a potential treatment for COVID-19, particularly for its antiviral properties against SARS-CoV-2. Early clinical trials conducted in China showed promising results, with significant improvements in pneumonia and lung imaging, and reductions in the duration of illness[1][4].

• Initial Findings: The first clinical results were reported in February 2020, indicating that chloroquine phosphate treatment resulted in significant improvements for over 100 patients in China. However, these findings were based on combined data from several ongoing trials with various study designs, and no empirical data supporting these findings have been published yet[1].
• Guidelines and Recommendations: Despite the limitations, official guidelines recommending the use of chloroquine phosphate for COVID-19 treatment were published by health authorities in China and Italy. For example, the National Health Commission of China recommended a dosage of 500mg chloroquine phosphate twice a day for up to 10 days[1].

Limitations and Future Research

The current evidence for chloroquine phosphate's effectiveness in treating COVID-19 is limited and plagued by several methodological issues, including the lack of randomization and potential allocation bias. Therefore, further clinical trials are crucial to understand its efficacy and safety fully[1].

• Ongoing Trials: Over twenty clinical trials are registered to test the use of chloroquine and hydroxychloroquine (a less toxic metabolite of chloroquine) for COVID-19 treatment. These trials employ various study designs and treatment approaches, which will provide more robust data on the drugs' effectiveness and safety[1].

Clinical Trials Update for Primaquine Phosphate

Malaria Treatment

Primaquine phosphate is the only drug available to treat Plasmodium vivax hypnozoites and prevent vivax relapses. Recent clinical trials and meta-analyses have provided valuable insights into its efficacy and safety.

• Efficacy Against P. vivax: A systematic review and individual patient data meta-analysis showed that primaquine treatment significantly reduced the risk of P. vivax recurrences. Low and high total dose regimens of primaquine demonstrated good antirelapse efficacy, with no severe haemolytic events in patients with normal glucose-6-phosphate dehydrogenase (G6PD) activity[3].
• Safety and Tolerability: The study highlighted that despite concerns about haemolysis, primaquine regimens appeared safe in patients with normal G6PD activity. The availability of point-of-care G6PD testing is facilitating the safer use of primaquine[3].

Market Analysis for Chloroquine Phosphate

COVID-19 Impact

The COVID-19 pandemic led to a surge in interest and demand for chloroquine phosphate, despite the limited evidence of its effectiveness. This demand was driven by initial promising results and subsequent inclusion in treatment guidelines.

• Market Dynamics: The market for chloroquine phosphate saw a temporary spike due to its potential use in COVID-19 treatment. However, the long-term market prospects are uncertain due to the ongoing need for robust clinical evidence and the emergence of other COVID-19 treatments[1].

Market Analysis for Primaquine Phosphate

Malaria Treatment Market

The market for primaquine phosphate is closely tied to the broader malaria treatment market, particularly in regions where Plasmodium vivax is prevalent.

• South America Market: In South America, the malaria treatment market, which includes primaquine phosphate, is expected to grow from $71.79 million in 2022 to $98.53 million by 2028. The approval of new drugs like tafenoquine and increased government initiatives are driving this growth[5].
• Segmentation: The market is segmented by treatment type, with prescription medications being a significant segment. Primaquine phosphate falls under this category, and its demand is expected to rise with the increasing need for effective malaria treatments[5].

Market Projections

Chloroquine Phosphate

The future market for chloroquine phosphate is uncertain and heavily dependent on the outcomes of ongoing clinical trials for COVID-19.

• Dependence on Clinical Trials: If further trials confirm its efficacy and safety, chloroquine phosphate could see a sustained market presence. However, if the evidence remains weak or other treatments prove more effective, its market share may decline[1].

Primaquine Phosphate

Primaquine phosphate is expected to maintain a strong market presence due to its critical role in treating Plasmodium vivax malaria.

• Growth Drivers: The market for primaquine phosphate is driven by government and private sector initiatives to combat malaria, the availability of point-of-care G6PD testing, and the lack of alternative treatments for P. vivax hypnozoites[3][5].

Key Challenges and Opportunities

Challenges

• Counterfeit Drugs: The presence of counterfeit antimalarial drugs, including chloroquine and primaquine, poses a significant challenge to the market and public health[5].
• Drug Resistance: The risk of drug resistance is another challenge that could impact the effectiveness and market demand for these drugs[5].

Opportunities

• New Drug Pipelines: The development of new antimalarial drugs and vaccines presents opportunities for growth in the malaria treatment market, which could indirectly benefit primaquine phosphate by increasing overall market size[5].
• Diagnostic Tests: The advancement in rapid diagnostic tests for malaria can enhance the targeted use of primaquine phosphate, improving its efficacy and market position[5].

Key Takeaways

• Chloroquine Phosphate: The drug's use in COVID-19 treatment is under scrutiny, with ongoing clinical trials needed to establish its efficacy and safety.
• Primaquine Phosphate: It remains a crucial drug for treating Plasmodium vivax malaria, with a strong market presence expected due to its efficacy and the lack of alternative treatments.
• Market Dynamics: Both drugs are influenced by broader health initiatives, regulatory approvals, and the development of new treatments and diagnostic tools.

FAQs

Q: What is the current status of chloroquine phosphate in treating COVID-19?

A: Chloroquine phosphate has shown initial promise in treating COVID-19, but the current evidence is limited and plagued by methodological issues. Further clinical trials are necessary to confirm its efficacy and safety.

Q: How effective is primaquine phosphate in treating P. vivax malaria?

A: Primaquine phosphate has been shown to significantly reduce the risk of P. vivax recurrences, with both low and high total dose regimens demonstrating good antirelapse efficacy.

Q: What are the main challenges facing the market for chloroquine and primaquine phosphate?

A: The main challenges include the risk of counterfeit drugs, potential drug resistance, and the need for robust clinical evidence to support their use.

Q: How is the market for malaria treatment expected to grow in the coming years?

A: The market for malaria treatment, including primaquine phosphate, is expected to grow driven by government initiatives, new drug pipelines, and advancements in diagnostic tests.

Q: What is the significance of G6PD testing in the use of primaquine phosphate?

A: G6PD testing is crucial to ensure the safe use of primaquine phosphate, as it can cause haemolysis in individuals with G6PD deficiency. The availability of point-of-care G6PD testing is facilitating its safer use.

Sources

1. Centre for Evidence-Based Medicine. Chloroquine and Hydroxychloroquine: Current Evidence for Their Effectiveness in Treating COVID-19. March 25, 2020.
2. Market Research Intellect. Global Primaquine Phosphate API Market Size, Scope And Forecast Report. January 2025.
3. BMJ Global Health. A systematic review and individual patient data meta-analysis. December 2023.
4. BioScience Trends. Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia. 2020.
5. GlobeNewswire. South America Malaria Treatment Market Report 2023: Extending Pipeline of New Drugs and Vaccines Presents Opportunities. March 9, 2023.