CLINICAL TRIALS PROFILE FOR ARALEN HYDROCHLORIDE

All Clinical Trials for ARALEN HYDROCHLORIDE

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.

Clinical Trial Conditions for ARALEN HYDROCHLORIDE

Condition Name

Condition Name for ARALEN HYDROCHLORIDE
Intervention	Trials
Malaria	3
Anemia in Children	2
Malaria,Falciparum	2
Metabolic Syndrome X	1

Condition MeSH

Condition MeSH for ARALEN HYDROCHLORIDE
Intervention	Trials
Malaria	5
Malaria, Falciparum	2
Multiple Myeloma	1
Infections	1

Clinical Trial Locations for ARALEN HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ARALEN HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ARALEN HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

Sponsor Type for ARALEN HYDROCHLORIDE
Sponsor	Trials
Other	31
NIH	4
U.S. Fed	3

Clinical Trials Update, Market Analysis, and Projection for Aralen Hydrochloride

Last updated: October 28, 2025

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Introduction

Aralen Hydrochloride, the hydrochloride salt of chloroquine, has historically served as an antimalarial agent with additional applications spanning autoimmune diseases. Recently, interest in its potential repurposing has resurfaced amid global health challenges, notably its debated role in COVID-19 treatment. This article provides a detailed analysis of current clinical trial activities, assesses the market landscape, and forecasts future trends for Aralen Hydrochloride.

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Clinical Trials Update

Current Status and Key Studies

Initially approved in the 1940s for malaria, Aralen Hydrochloride's clinical research pipeline has experienced fluctuations driven by emerging unmet medical needs and shifting regulatory landscapes.

As of 2023, the clinical trial landscape shows:

• Revived Interest in Pandemic Contexts: Several studies have explored chloroquine derivatives, including Aralen Hydrochloride, for antiviral activity against SARS-CoV-2. Clinicaltrials.gov reports approximately 15 active or completed trials investigating its efficacy, mostly Phase II and III, primarily focusing on COVID-19. Notably, the REMAP-COVID trial conducted in Australia concluded that chloroquine/hydroxychloroquine did not significantly improve outcomes, leading to decreased enthusiasm ([1]).

• Autoimmune and Rheumatologic Applications: Trials continue exploring Aralen’s role in managing autoimmune diseases like lupus erythematosus, with multiple Phase III studies demonstrating established efficacy and safety profiles.

• Ongoing Investigations: Some research centers are investigating novel formulations and combination therapies to enhance therapeutic effects, especially in refractory cases.

Regulatory Developments

Major health agencies, including the FDA and EMA, have restricted or withdrawn emergency use authorizations related to chloroquine derivatives in COVID-19 due to lack of consistent evidence for benefit and safety concerns such as cardiotoxicity ([2]).

In contrast, regulatory bodies maintain standards for traditional uses in autoimmune disease management, and post-marketing surveillance continues to confirm safety profiles in these contexts.

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Market Analysis

Historical Market Performance

Traditionally, Aralen Hydrochloride's market was primarily driven by annual prescriptions for malaria and autoimmune diseases, with estimated global sales reaching approximately USD 150-200 million pre-pandemic (2019).

Current Market Dynamics

The COVID-19 pandemic:

• Led to a surge in demand for chloroquine and hydroxychloroquine, briefly elevating Aralen Hydrochloride in global markets. However, this spike was short-lived due to emerging safety concerns and clinical trial results ([3]).

• Manufacturing Volume Reduction: Many producers scaled back output owing to declining demand post-pandemic hype and regulatory cautions.

• Regulatory Restrictions: The loss of emergency use authorizations contributed to market contraction. The World Health Organization (WHO) and other agencies issued advisories against the routine use of these drugs for COVID-19 outside clinical trials.

Market Opportunities and Challenges

• Niche Markets: The FDA’s ongoing approval for autoimmune indications sustains a niche but stable market segment.

• Repricing and Competition: Generic manufacturing dominates, with multiple companies producing low-cost formulations.

• Innovation Barriers: Limited investment due to declining interest in COVID-19 indications constrains new product development and clinical trials.

Emerging Markets and Supply Chain Factors

• The drug remains a low-cost, off-patent medication accessible in developing regions, especially Africa and Southeast Asia, where malaria prevalence offsets demand fluctuations.

• Supply chain vulnerabilities, including raw material sourcing and manufacturing disruptions due to geopolitical factors, pose risks to steady availability.

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Market Projections

Short-Term Outlook (Next 1–3 Years)

• Stability in Traditional Use Markets: Autoimmune and malaria markets will continue to generate steady revenue, with estimated annual growth rates of 1-3%, driven by increasing autoimmune disease diagnoses.

• Decline in COVID-19 Related Demand: The use of Aralen Hydrochloride for COVID-19 will remain negligible due to safety and efficacy concerns.

• Regulatory Environment: Tightened oversight will sustain limited off-label use and favor established indications.

Medium to Long-Term Outlook (3–10 Years)

• Potential for Repositioning: Research exploring synergistic combinations or targeted formulations might rekindle interest, although significant investment is unlikely without clear clinical benefits.

• Focus on Autoimmune Disease Management: As the global autoimmune burden grows, demand for chloroquine-based therapies may increase modestly, particularly if novel delivery systems improve efficacy or reduce side effects.

• Market Size Forecast: The global Aralen Hydrochloride market is projected to stabilize around USD 100-120 million annually by 2030, primarily driven by autoimmune therapy use and malaria control in endemic regions ([4]).

• Emerging Technological Developments: Innovations such as nanoparticle delivery, which could enhance tissue targeting and reduce toxicity, may influence future market dynamics, although these are in early research stages.

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Key Takeaways

• Clinical Trials: Current research activity centers on autoimmune and traditional indications, with minimal ongoing evaluation of the drug for COVID-19, reflecting shifting clinical priorities.

• Market Trends: Post-pandemic demand downturns, regulatory restrictions, and generic competition have reduced market size. The drug maintains niche relevance primarily in autoimmune treatment.

• Future Outlook: The overall market for Aralen Hydrochloride faces marginal growth, emphasizing stability over expansion. Innovation in formulations and targeted therapies could offer incremental growth opportunities.

• Regulatory and Safety Profile: The long-standing safety profile supports continued use in approved indications, but new clinical evidence is necessary to expand applications.

• Strategic Focus: Stakeholders should prioritize optimization of current indications and investigate novel delivery methods rather than speculative COVID-19 applications.

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FAQs

1. Is Aralen Hydrochloride effective against COVID-19?
Current evidence from large-scale clinical trials indicates that Aralen Hydrochloride does not provide significant clinical benefits for COVID-19 patients, leading authorities to contraindicate its routine use for this purpose.

2. What are the primary approved indications for Aralen Hydrochloride?
It is FDA-approved for the prophylaxis and treatment of malaria and has an established role in managing autoimmune conditions such as systemic lupus erythematosus and rheumatoid arthritis.

3. How has the COVID-19 pandemic influenced the market for Aralen Hydrochloride?
Initially, demand surged due to early hypotheses and studies, but subsequent negative trial results and safety concerns rapidly diminished its market appeal, reverting demand to traditional levels.

4. Are there recent advancements or innovations involving Aralen Hydrochloride?
Research into novel delivery systems and combination therapies continues in early phases; however, no major breakthroughs have emerged to significantly alter its market trajectory.

5. What regulatory considerations should stakeholders monitor?
Authorities continue to enforce strict guidelines on off-label use and safety monitoring. Investment in new indications requires rigorous clinical validation and regulatory approval pathways.

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References

[1] clinicaltrials.gov. "Chloroquine or Hydroxychloroquine for COVID-19." Accessed 2023.

[2] U.S. FDA. "COVID-19 Update: Chloroquine and Hydroxychloroquine." 2022.

[3] World Health Organization. "Rational use of COVID-19 therapeutics." 2021.

[4] MarketWatch. "Global Chloroquine Market Report." 2022.

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In Summary: Aralen Hydrochloride’s clinical and market landscape is characterized by a return to its traditional therapeutic areas, with minimal indications for COVID-19 treatment. While its market remains stable, significant growth opportunities are limited without new clinical evidence or technological innovations. Industry stakeholders should focus on optimizing existing indications and explore research on improved drug delivery to sustain its relevance.