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.
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 Hydrochloride

Condition Name

Condition Name for Aralen Hydrochloride
Intervention	Trials
Malaria	3
Malaria,Falciparum	2
Anemia in Children	2
Solid Tumors	1

Condition MeSH

Condition MeSH for Aralen Hydrochloride
Intervention	Trials
Malaria	5
Malaria, Falciparum	2
Carcinoma, Intraductal, Noninfiltrating	1
Infection	1

Clinical Trial Locations for Aralen Hydrochloride

Trials by Country

Trials by Country for Aralen Hydrochloride
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 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
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 Hydrochloride
Sponsor	Trials
Other	31
NIH	4
U.S. Fed	3

Aralen Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Aralen Hydrochloride, also known as chloroquine hydrochloride, is a drug that has been historically used for the treatment and prevention of malaria. In recent years, it has been at the center of attention due to its potential use in treating COVID-19. Here, we will delve into the latest updates on clinical trials, market analysis, and future projections for Aralen Hydrochloride.

Clinical Trials Update

COVID-19 Treatment Trials

One of the most significant recent developments involving Aralen Hydrochloride is its evaluation as a potential treatment for COVID-19. Several clinical trials were initiated to assess the efficacy of chloroquine and its derivative, hydroxychloroquine, in treating patients infected with the novel coronavirus.

• FDA Revocation of EUA: The FDA revoked the Emergency Use Authorization (EUA) for chloroquine and hydroxychloroquine in treating COVID-19 due to a lack of evidence showing their effectiveness. Clinical trials, including large randomized studies, demonstrated no benefit in terms of mortality or recovery speed for hospitalized patients[1][4].

• Ongoing Trials: Despite the FDA's revocation, some clinical trials continued to evaluate these drugs. For example, a trial at Washington University School of Medicine investigated the effectiveness of chloroquine and hydroxychloroquine, both alone and in combination with the antibiotic azithromycin, in treating hospitalized COVID-19 patients. These trials aimed to clarify the unclear results from earlier small studies[4].

Other Clinical Uses

Apart from COVID-19, Aralen Hydrochloride is used in treating malaria and certain autoimmune disorders like lupus and rheumatoid arthritis. However, there are no recent significant clinical trials specifically focused on these indications.

Market Analysis

Current Market Status

The market for antimalarial drugs, including Aralen Hydrochloride, is influenced by several factors such as the prevalence of malaria, the availability of alternative treatments, and regulatory approvals.

• Sales Performance: The sales performance of antimalarial drugs is generally lower compared to other therapeutic areas like oncology. According to a market analysis, antimicrobial drugs, which include antimalarials, have average to high development and approval costs but lower capitalized development and approval costs compared to oncology drugs. The cumulative sales for antimalarial drugs are significantly lower than those for oncology drugs[2].

• Distribution Channels: Aralen Hydrochloride is distributed through various channels including pharmacies, hospitals, and online retailers. The distribution strategy can impact the drug's market reach and accessibility[5].

Market Projections

Growth Forecast

The quinine market, which includes Aralen Hydrochloride, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.81% to reach USD 3.21 billion by 2032. This growth is driven by the increasing demand for malaria treatment and other applications such as nocturnal leg cramps and muscle pain[5].

Regional Analysis

The market for Aralen Hydrochloride is expected to vary by region, with significant demand in areas where malaria is prevalent, such as Africa and Asia-Pacific. North America and Europe also contribute to the market, primarily due to the treatment of autoimmune disorders and other off-label uses[5].

Regulatory Environment

FDA and EUA

The FDA's decision to revoke the EUA for chloroquine and hydroxychloroquine in treating COVID-19 significantly impacted the drug's market. This decision was based on rigorous scientific evaluation and the lack of evidence supporting the drugs' effectiveness against COVID-19[1].

Global Regulations

Regulatory environments in different countries can affect the market for Aralen Hydrochloride. For instance, some countries may have stricter regulations or different approval processes that can influence the drug's availability and sales.

Competitive Landscape

Generic Formulations

Aralen Hydrochloride is available in generic formulations, which can affect its market pricing and competition. Generic versions of the drug are often cheaper and can capture a significant market share, impacting the sales of branded versions[4].

Alternative Treatments

The availability of alternative treatments for malaria and autoimmune disorders also influences the market for Aralen Hydrochloride. Newer drugs or therapies that offer better efficacy or safety profiles can reduce the demand for Aralen Hydrochloride.

Future Prospects

Research and Development

While the current focus on Aralen Hydrochloride as a COVID-19 treatment has waned due to lack of efficacy, ongoing research in other therapeutic areas could revitalize interest in the drug. For example, studies on its use in treating autoimmune disorders or other infectious diseases could open new market opportunities.

Market Expansion

Expanding into new markets, particularly in regions with high malaria prevalence, could drive growth for Aralen Hydrochloride. This could involve strategic partnerships with local healthcare providers and governments to increase accessibility and affordability.

Key Takeaways

• Clinical Trials: Recent clinical trials have shown that Aralen Hydrochloride is unlikely to be effective in treating COVID-19, leading to the revocation of its EUA.
• Market Analysis: The drug's market performance is lower compared to other therapeutic areas, but it still has a significant presence in the antimalarial market.
• Market Projections: The quinine market, including Aralen Hydrochloride, is projected to grow at a CAGR of 5.81% to reach USD 3.21 billion by 2032.
• Regulatory Environment: Regulatory decisions, such as the FDA's revocation of EUA, significantly impact the drug's market.
• Competitive Landscape: Generic formulations and alternative treatments are key factors influencing the market for Aralen Hydrochloride.

FAQs

What was the outcome of the FDA's review on Aralen Hydrochloride for COVID-19 treatment?

The FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19, leading to the revocation of their Emergency Use Authorization (EUA)[1].

How does Aralen Hydrochloride compare to other therapeutic areas in terms of market performance?

Aralen Hydrochloride and other antimicrobial drugs generally have lower market sales compared to oncology drugs, despite having lower development and approval costs[2].

What are the projected growth and market size for the quinine market, which includes Aralen Hydrochloride?

The quinine market is projected to grow at a CAGR of 5.81% to reach USD 3.21 billion by 2032[5].

What are the primary distribution channels for Aralen Hydrochloride?

The primary distribution channels include pharmacies, hospitals, and online retailers[5].

Are there ongoing clinical trials for Aralen Hydrochloride beyond COVID-19 treatment?

There are no recent significant clinical trials specifically focused on other indications for Aralen Hydrochloride beyond the COVID-19 trials.

How does the availability of generic formulations affect the market for Aralen Hydrochloride?

Generic formulations of Aralen Hydrochloride can capture a significant market share due to their lower pricing, impacting the sales of branded versions[4].

Sources

1. FDA: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine.
2. ASPE: Antimicrobial Drugs Market Returns Analysis.
3. ClinicalTrials.gov: Sponsor - ClinicalTrials.gov.
4. Washington University School of Medicine: Clinical trial launches to evaluate antimalarial drugs for COVID-19 treatment.
5. Market Research Future: Quinine Market Size, Growth Analysis, Trends, Report 2032.