CLINICAL TRIALS PROFILE FOR CHLOROQUINE PHOSPHATE

All Clinical Trials for CHLOROQUINE PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	DBL -Institute for Health Research and Development	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	Gates Malaria Partnership	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	London School of Hygiene and Tropical Medicine	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
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.

Clinical Trial Conditions for CHLOROQUINE PHOSPHATE

Condition Name

Condition Name for CHLOROQUINE PHOSPHATE
Intervention	Trials
Covid-19	12
Malaria	10
Malaria, Vivax	4
Vivax Malaria	4

Condition MeSH

Condition MeSH for CHLOROQUINE PHOSPHATE
Intervention	Trials
Malaria	18
COVID-19	16
Malaria, Vivax	10
Coronavirus Infections	5

Clinical Trial Locations for CHLOROQUINE PHOSPHATE

Trials by Country

Trials by Country for CHLOROQUINE PHOSPHATE
Location	Trials
Indonesia	11
United States	9
Thailand	8
Ethiopia	5
Brazil	5

Trials by US State

Trials by US State for CHLOROQUINE PHOSPHATE
Location	Trials
New York	2
Arizona	1
Connecticut	1
Virginia	1
Maryland	1

Clinical Trial Progress for CHLOROQUINE PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for CHLOROQUINE PHOSPHATE
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for CHLOROQUINE PHOSPHATE
Clinical Trial Phase	Trials
Completed	27
Not yet recruiting	7
Terminated	4

Clinical Trial Sponsors for CHLOROQUINE PHOSPHATE

Sponsor Name

Sponsor Name for CHLOROQUINE PHOSPHATE
Sponsor	Trials
University of Oxford	7
Shahid Beheshti University of Medical Sciences	4
Medicines for Malaria Venture	4

Sponsor Type

Sponsor Type for CHLOROQUINE PHOSPHATE
Sponsor	Trials
Other	121
Industry	9
U.S. Fed	3

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

Last updated: October 26, 2025

Introduction

Chloroquine phosphate, historically used as an antimalarial agent, has garnered renewed interest amid global health crises due to its potential antiviral properties. Although initially overshadowed by newer drugs, recent regulatory developments, clinical investigations, and market dynamics highlight its evolving role in therapeutic applications. This article provides a comprehensive analysis of the current clinical trials, market trends, and future projections for chloroquine phosphate, equipping stakeholders with actionable insights.

Clinical Trials Status and Developments

Overview of Ongoing and Completed Trials

Chloroquine phosphate has been under scrutiny since early 2020, primarily propelled by preliminary research suggesting antiviral activity against SARS-CoV-2. As of late 2023, over 100 clinical trials globally have explored its efficacy in COVID-19 treatment, with a significant concentration in China, India, and the United States.

Most trials aim to determine optimal dosing, safety profile, and efficacy in reducing viral load and preventing disease progression. For instance:

• Randomized Controlled Trials (RCTs): Many RCTs, such as the WHO-led SOLIDARITY trial, initially assessed chloroquine but later deprioritized its use due to mixed outcomes.
• Observational Studies: Several observational studies indicated potential benefits, but lacked the robustness to influence regulatory approval.
• Combination Therapy Trials: Recent investigations combine chloroquine with other agents like azithromycin, aiming to potentiate antiviral effects.

Regulatory and Safety Considerations

Regulatory agencies have exhibited cautious optimism. The FDA revoked emergency use authorization (EUA) for chloroquine in COVID-19 in 2020, citing safety concerns linked to cardiac toxicity ([1]). Similarly, the WHO suspended hydroxychloroquine trials pending further data.

However, ongoing trials with refined dosing and patient selection continue. For instance, the Indian Council of Medical Research (ICMR) issued guidelines endorsing prophylactic use for healthcare workers in certain contexts, based on preliminary data ([2]).

Recent Advances and Future Directions

Emerging research focuses on:

• Mechanistic Insights: Clarifying mechanisms of antiviral activity, such as interfering with endosomal pH and immune modulation.
• Novel Formulations: Developing targeted delivery systems to minimize toxicity.
• Biomarker-driven Trials: Stratifying patients based on genetic or immunological markers to identify responders.

Though conclusive evidence remains elusive, the momentum suggests chloroquine phosphate will continue to be scrutinized alongside new antiviral candidates.

Market Analysis

Historical Market Landscape

Initially, chloroquine phosphate represented a robust market segment within antimalarial drugs, with Pfizer, Sanofi, and Novartis being major players. The global antimalarial market was valued at approximately USD 3.5 billion in 2021, driven by endemic regions in Africa, Asia, and South America ([3]).

The COVID-19 pandemic introduced a speculative surge in demand, temporarily inflating prices and prompting stockpiling. However, safety concerns and mixed efficacy outcomes rapidly tempered this enthusiasm, causing a sharp decline in global sales.

Current Market Dynamics

As of 2023, the market is characterized by:

• Market Contraction: Pharmaceutical companies have scaled back production due to regulatory setbacks and the decline in off-label use.
• Residual Demand in Certain Markets: India and China sustain moderate demand, notably for prophylaxis and off-label uses, driven by government policies.
• Niche Markets: Investigational or compassionate use remains pertinent for specific patient subsets under regulatory oversight.

Competitive Landscape

Chloroquine phosphate faces competition from:

• Hydroxychloroquine: Slightly less toxic, with ongoing investigation into similar antiviral properties.
• Remdesivir and Paxlovid: More advanced antivirals with demonstrated efficacy, overshadowing chloroquine.
• Traditional Antimalarials: Artemisinin derivatives maintaining dominance in endemic zones.

Regulatory Outlook and Market Reentry Potential

Potential reentry hinges on positive clinical trial outcomes. Should future data establish definitive safety and efficacy in other viral or autoimmune indications, the market could pivot towards niche therapeutic areas, including:

• Autoimmune diseases (e.g., lupus)
• Certain viral infections beyond COVID-19

Market projections are sensitive to these variables, but in the absence of confirmed efficacy, the overall market remains subdued.

Market Forecast for Chloroquine Phosphate (2024-2030)

Given current evidence, the global market for chloroquine phosphate is expected to:

• Decline at a CAGR of 4-6% over the next five years, primarily due to shrinking demand in the traditional antimalarial sector.
• Remain stable in selected markets such as India, where government protocols continue to endorse its prophylactic use.
• Potentially rebound if novel indications are validated through rigorous clinical research, particularly in autoimmune and antiviral therapies.

A conservative estimate projects the market could sustain around USD 1.2 billion by 2030, largely fueled by generic manufacturers and emerging niche applications.

Regulatory and Commercial Outlook

Regulatory agencies are likely to maintain a cautious stance unless conclusive evidence emerges. Nevertheless, pharmaceutical companies are investing in reformulations and combination therapies that might mitigate toxicity and improve efficacy.

Private sector interest remains moderate but is adaptable, pending breakthroughs from ongoing research programs. Patent protection has long expired, favoring generic proliferation, which could stabilize pricing but limit profitability margins.

Key Takeaways

• Clinical trials for chloroquine phosphate have produced mixed outcomes; definitive efficacy against COVID-19 remains unestablished.
• Safety concerns, especially cardiotoxicity, have led to regulatory restrictions, curbing widespread use.
• The market experienced a temporary surge during the pandemic but has since contracted, with limited recovery prospects unless new therapeutic indications emerge.
• Future growth hinges on successful clinical validation in autoimmune or antiviral domains, alongside formulation advancements.
• Stakeholders should closely monitor ongoing research, regulatory shifts, and emerging niche applications to inform strategic decisions.

FAQs

1. Is chloroquine phosphate effective for COVID-19 treatment?
Current robust evidence does not confirm efficacy; major health authorities recommend against routine use outside clinical trials due to safety and inconsistent efficacy data.

2. What are the main safety concerns associated with chloroquine phosphate?
Primarily, cardiotoxicity (QT interval prolongation), which can lead to arrhythmias, especially when combined with other QT-prolonging drugs.

3. Can chloroquine phosphate be used for non-malarial indications?
It is approved for autoimmune conditions like lupus and rheumatoid arthritis. Emerging research on antiviral applications is ongoing but not yet conclusive.

4. How has the market for chloroquine phosphate changed post-pandemic?
It has declined from pandemic-driven peaks, stabilizing primarily in regions with established therapeutic uses, with limited upside unless new indications are validated.

5. What is the outlook for generic manufacturers of chloroquine phosphate?
They are poised to continue supplying the market for existing indications, with potential expansion if new therapeutic uses are approved and supported by clinical data.

References

[1] U.S. Food and Drug Administration. (2020). "FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine." www.fda.gov.

[2] Indian Council of Medical Research. (2020). "Guidelines for the Use of Chloroquine for COVID-19." www.icmr.gov.in.

[3] MarketWatch. (2022). "Global Antimalarial Drugs Market Report." www.marketwatch.com.