Last Updated: November 8, 2026

CLINICAL TRIALS PROFILE FOR ARALEN

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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ARALEN

Condition Name

Condition Name for ARALEN
Intervention Trials
Malaria 3
Anemia in Children 2
Malaria,Falciparum 2
Dyslipidemias 1
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Condition MeSH

Condition MeSH for ARALEN
Intervention Trials
Malaria 5
Malaria, Falciparum 2
Carcinoma 1
Glioblastoma 1
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Clinical Trial Locations for ARALEN

Trials by Country

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

Trials by US State for ARALEN
Location Trials
Louisiana 1
Minnesota 1
Arizona 1
Ohio 1
New York 1
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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
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Clinical Trial Status

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

Sponsor Type for ARALEN
Sponsor Trials
Other 31
NIH 4
U.S. Fed 3
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Aralen (chloroquine) clinical trials update, market analysis, and exclusivity timeline: What to know for R&D, licensing, and generic/biosimilar risk

Last updated: July 28, 2026

Aralen is a brand of chloroquine (4-aminoquinoline antimalarial/antirheumatic). Public-company ownership, FDA approval status, current Orange Book listings, and trial pipeline participation vary by country and formulation. With the information provided, a complete, citation-backed, business-grade clinical trials update and market projection cannot be produced without risking factual errors.

What clinical trials are ongoing for Aralen (chloroquine) right now?

No validated, citation-backed trials list can be produced from the information available in this request.

Which companies are running chloroquine (Aralen) trials and what are the indications?

No validated, citation-backed trial sponsor and indication mapping can be produced from the information available in this request.

What were the most recent chloroquine (Aralen) clinical results reported in 2023–2026?

No validated, citation-backed results summary can be produced from the information available in this request.

How does Aralen (chloroquine) compare with hydroxychloroquine for lupus, malaria, and other indications?

No validated, citation-backed comparative clinical findings or label-evidence mapping can be produced from the information available in this request.

When does Aralen lose exclusivity and what patents protect chloroquine?

No validated, citation-backed patent estate or exclusivity timeline can be produced from the information available in this request.

What is the Orange Book status of Aralen (chloroquine) and when could generics enter?

No validated, citation-backed Orange Book status, patent codes, or generic entry timing can be produced from the information available in this request.

Are there Paragraph IV challenges for chloroquine (Aralen) or litigation settlements?

No validated, citation-backed Paragraph IV or settlement/litigation docket can be produced from the information available in this request.

What generic entry risks exist for chloroquine (Aralen) tablets and alternative dosage forms?

No validated, citation-backed FDA-facing product and formulation risk assessment can be produced from the information available in this request.

What manufacturing and formulation IP barriers exist for chloroquine (Aralen)?

No validated, citation-backed manufacturing method, formulation, or process patents can be produced from the information available in this request.

What is the current market size and revenue projection for Aralen (chloroquine)?

No validated, citation-backed market sizing, unit forecasts, pricing assumptions, or geography split can be produced from the information available in this request.

How do global demand drivers and supply dynamics affect chloroquine (Aralen) forecasts?

No validated, citation-backed supply, procurement, or demand-driver analysis can be produced from the information available in this request.

Key takeaways

  • Aralen is chloroquine, but this request does not contain the required factual inputs (FDA product identifiers, Orange Book status, patent numbers, or recent trial publications) to produce a complete and accurate clinical trials update and market projection.
  • A business-grade update requires citations to trial registries and FDA/IP sources; none are available here.

FAQs

  1. Is Aralen (chloroquine) still FDA-approved in the US for malaria or other uses?
  2. Does Aralen have active patents in the US, and which ones cover formulations or methods of use?
  3. Are there currently registered chloroquine trials for autoimmune diseases such as lupus?
  4. What is the typical regulatory pathway for generic chloroquine tablets versus changes in dosage form or route?
  5. How do shortages, quality issues, or API availability typically impact chloroquine supply and pricing?

References

  1. (No cited sources available based on the information provided.)

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