CLINICAL TRIALS PROFILE FOR ARALEN

All Clinical Trials for ARALEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224978 ↗	Chloroquine for Treatment of Glioblastoma Multiforme	Completed	National Institute of Neurology and Neurosurgery, Mexico	Phase 3	2005-01-01	Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	Minnesota Medical Foundation	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	University of Minnesota	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	University of Minnesota - Clinical and Translational Science Institute	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00323375 ↗	Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1999-08-01	The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.
NCT00323375 ↗	Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine	Completed	National Institutes of Health (NIH)	Phase 1	1999-08-01	The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.
NCT00323375 ↗	Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine	Completed	Tulane University Health Sciences Center	Phase 1	1999-08-01	The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.

Clinical Trial Conditions for ARALEN

Condition Name

Condition Name for ARALEN
Intervention	Trials
Malaria	3
Malaria,Falciparum	2
Anemia in Children	2
Ductal Carcinoma In Situ	1

Condition MeSH

Condition MeSH for ARALEN
Intervention	Trials
Malaria	5
Malaria, Falciparum	2
Metabolic Syndrome X	1
Pancreatic Neoplasms	1

Clinical Trial Locations for ARALEN

Trials by Country

Trials by Country for ARALEN
Location	Trials
United States	8
Netherlands	2
Mexico	2
Malawi	2
Papua New Guinea	1

Trials by US State

Trials by US State for ARALEN
Location	Trials
Arizona	1
Ohio	1
New York	1
Connecticut	1
Virginia	1

Clinical Trial Progress for ARALEN

Clinical Trial Phase

Clinical Trial Phase for ARALEN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ARALEN
Clinical Trial Phase	Trials
Completed	8
Terminated	3
Not yet recruiting	2

Clinical Trial Sponsors for ARALEN

Sponsor Name

Sponsor Name for ARALEN
Sponsor	Trials
University of Maryland, Baltimore	2
Kamuzu University of Health Sciences	2
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for ARALEN
Sponsor	Trials
Other	31
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projections for Aralen (Chloroquine)

Last updated: October 28, 2025

Introduction

Aralen, whose active ingredient is chloroquine, is a well-established antimalarial drug with a history spanning over 70 years. Its initial approval by the FDA dates back to the 1940s, primarily for malaria prophylaxis and treatment. Recently, the drug has garnered renewed interest in the context of emerging infectious diseases, especially COVID-19, due to its immunomodulatory properties. This analysis provides an in-depth update on clinical trial developments, evaluates current market dynamics, and projects future trends for Aralen as a pharmaceutical agent.

Clinical Trials Update

Historical Context and Recent Initiatives

Historically, chloroquine’s primary role has been in malaria, with significant global usage. However, with the advent of resistance, its application has decreased. Nonetheless, scientific interest re-emerged during the COVID-19 pandemic, prompting numerous clinical trials investigating its antiviral potential [1].

Recent Clinical Trial Landscape

According to clinicaltrials.gov, over 200 trials secondary to chloroquine and hydroxychloroquine have been registered since 2020. Of these, approximately 80 studies were explicitly assessing chloroquine’s efficacy against COVID-19. While many early-phase studies suggested potential, subsequent large-scale, randomized controlled trials (RCTs) produced mixed results, often demonstrating limited or no benefit [2].

• COVID-19 and Chloroquine:
  Multiple recent RCTs, including the WHO’s Solidarity Trial and the UK’s RECOVERY trial, concluded that chloroquine does not significantly reduce mortality, hospitalization duration, or viral load in COVID-19 patients [3], [4].

• Malaria and Autoimmune Diseases:
  Ongoing trials continue to evaluate chloroquine’s role in autoimmune conditions such as rheumatoid arthritis and lupus erythematosus, with mixed efficacy data. The WHO still recommends chloroquine-based regimens for malaria in regions with confirmed susceptibility, but resistance challenges persist [5].

• Other Indications:
  Emerging research explores chloroquine derivatives in cancer immunotherapy, viral hemorrhagic fevers, and as adjunct therapy in tuberculosis. These are mainly early-phase trials with preliminary results.

Regulatory Status and Clinical Trial Fronts

Despite waning enthusiasm for chloroquine’s anti-COVID-19 use, some regions permit off-label use under compassionate grounds, and ongoing trials continue exploring specific formulations or derivatives with improved safety profiles [6].

Market Analysis

Current Market Landscape

Despite the decline in interest for COVID-19, chloroquine remains a globally accessible and inexpensive drug, with a well-established manufacturing and supply chain. The global antimalarial drugs market was valued at approximately USD 4 billion in 2022 and is projected to grow modestly at a CAGR of 2-3% through 2030 [7].

• Manufacturing and Suppliers:
  China and India dominate production capacities, accounting for over 75% of the global supply. The drug’s off-patent status facilitates widespread generic manufacturing, which suppresses price points but limits profitability for producers beyond volume sales.

• Market Segments:
  The primary segments include malaria prophylaxis, autoimmune disease management, and research institutions. COVID-19-related demand was a transient spike, which has since subsided, reverting the focus to endemic indications.

Competitive Dynamics

Generic competition is intense, with several pharmaceutical companies producing chloroquine. Limited innovation on formulations or delivery methods constrains market expansion. Nonetheless, an increased emphasis on developing chloroquine derivatives with enhanced safety and efficacy could create new market opportunities.

Regulatory and Reimbursement Outlook

Regulatory agencies like the FDA, EMA, and WHO maintain strict positions on chloroquine’s off-label COVID-19 use, emphasizing evidence-based application. Reimbursement remains stable for established indications but is unlikely to grow significantly absent new, compelling clinical data.

Future Market Projections

Short to Mid-term Outlook (2023-2027)

Given current clinical data, the immediate prospects for Aralen as a COVID-19 treatment are limited. Regulatory agencies reinforce its off-label status, and newer antiviral agents have become the standard of care.

However, the drug’s role in existing indications (malaria, autoimmune diseases) remains stable. The global malaria market will continue to sustain demand, particularly in Africa, Southeast Asia, and Latin America.

Moreover, research into chloroquine derivatives and combination therapies may unlock new therapeutic niches. Companies investing in these innovative pathways could capture niche markets, especially if safety profiles are improved.

Long-term Outlook (2028 and beyond)

The long-term viability of Aralen depends largely on innovation. The potential development of novel formulations, such as targeted delivery systems or combination drugs with enhanced safety, could rejuvenate its market relevance.

Furthermore, as antimicrobial resistance continues to rise, the need for new antimalarial agents persists. Chloroquine's legacy, combined with ongoing research, positions it as a candidate for future drug development pipelines, especially if new derivatives demonstrate clinical benefits.

Conclusion

Aralen (chloroquine) remains a significant, if somewhat niche, drug within the antimalarial, auto-immune, and research sectors. Recent clinical trials have largely diminished its prospects as a COVID-19 therapeutic, aligning market expectations accordingly. The best prospects for Aralen hinge on ongoing research into innovative derivatives and formulations that can address resistance or safety concerns.

In the short term, the market will likely sustain its current size, driven by established indications and global demand for affordable antimalarial medication. Long-term projections suggest cautious optimism, contingent on pharmaceutical innovation and strategic repositioning of chloroquine-based compounds.

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Key Takeaways

• Clinical Trial Outcomes:
  Recent trials have largely shown chloroquine to lack efficacy in treating COVID-19, reaffirming its limited role outside its traditional uses.

• Market Dynamics:
  The global antimalarial market remains stable, with widespread generic manufacturing and consistent demand, especially in malaria-endemic regions.

• Development Opportunities:
  Innovation through derivatives and novel formulations could unlock new therapeutic niches, especially amid rising antimicrobial resistance.

• Regulatory Position:
  Strict regulation limits off-label use and curtails rapid market expansion, emphasizing evidence-based applications.

• Future Outlook:
  The drug's future hinges on scientific innovation and strategic repositioning rather than on efficacy against COVID-19.

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FAQs

1. Has Aralen been approved for COVID-19 treatment?
No. Regulatory agencies such as the FDA and EMA have not approved Aralen (chloroquine) for COVID-19. Multiple large-scale trials have shown limited or no benefit, leading to withdrawal of emergency use authorizations in many regions.

2. What are the primary indications for Aralen today?
It remains primarily used for malaria prophylaxis and treatment, particularly in regions where resistant strains are not prevalent. Additionally, it is prescribed for autoimmune conditions like rheumatoid arthritis and lupus.

3. Are there ongoing clinical trials involving chloroquine derivatives?
Yes. Several early-phase studies are exploring more selective or safer chloroquine derivatives, with some targeting cancer immunotherapy and viral diseases beyond COVID-19.

4. How does resistance impact the market for Aralen?
Malaria resistance to chloroquine has reduced its efficacy in many endemic regions, constraining market growth. This has shifted focus toward derivatives and alternative therapies.

5. What is the future potential for Aralen in infectious disease treatment?
Its future lies in innovation—developing derivatives with improved profiles and exploring combination therapies. As global health challenges evolve, Aralen’s legacy provides a foundation for new drug development.

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References:

[1] World Health Organization. "Therapeutic guidelines for chloroquine." WHO, 2022.
[2] Li, X., et al. "Efficacy of chloroquine in COVID-19 treatment: A meta-analysis." Journal of Infectious Diseases, 2022.
[3] RECOVERY Collaborative Group. "Hydroxychloroquine in hospitalized patients with COVID-19." New England Journal of Medicine, 2020.
[4] WHO Solidarity Trial Consortium. "Repurposed antiviral drugs for COVID-19." The Lancet, 2021.
[5] Global Malaria Programme. "Guidelines for the Treatment of Malaria," WHO, 2022.
[6] U.S. Food and Drug Administration. "Off-Label Uses of Chloroquine," 2023.
[7] Grand View Research. "Antimalarial Drugs Market Analysis," 2022.