CLINICAL TRIALS PROFILE FOR CHLOROQUINE HYDROCHLORIDE

505(b)(2) Clinical Trials for CHLOROQUINE HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Mahidol Oxford Tropical Medicine Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
New Formulation	NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Shoklo Malaria Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

All Clinical Trials for CHLOROQUINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00074841 ↗	Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India	Completed	Pfizer	Phase 2/Phase 3	2003-09-01	This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.
NCT00082563 ↗	Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum	Terminated	Pfizer	Phase 2	2004-08-01	The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.
NCT00082576 ↗	Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa	Completed	Pfizer	Phase 2/Phase 3	2004-06-01	The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00084227 ↗	Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America	Completed	Pfizer	Phase 2/Phase 3	2004-07-01	The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.

Clinical Trial Conditions for CHLOROQUINE HYDROCHLORIDE

Condition Name

Condition Name for CHLOROQUINE HYDROCHLORIDE
Intervention	Trials
Malaria	70
COVID-19	50
Vivax Malaria	19
Malaria, Vivax	17

Condition MeSH

Condition MeSH for CHLOROQUINE HYDROCHLORIDE
Intervention	Trials
Malaria	146
COVID-19	86
Malaria, Vivax	46
Malaria, Falciparum	40

Clinical Trial Locations for CHLOROQUINE HYDROCHLORIDE

Trials by Country

Trials by Country for CHLOROQUINE HYDROCHLORIDE
Location	Trials
United States	59
Brazil	57
Spain	21
Thailand	20
India	20

Trials by US State

Trials by US State for CHLOROQUINE HYDROCHLORIDE
Location	Trials
New York	10
Maryland	7
Missouri	5
Connecticut	3
Ohio	3

Clinical Trial Progress for CHLOROQUINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CHLOROQUINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for CHLOROQUINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	181
Not yet recruiting	35
Terminated	31

Clinical Trial Sponsors for CHLOROQUINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CHLOROQUINE HYDROCHLORIDE
Sponsor	Trials
London School of Hygiene and Tropical Medicine	25
University of Oxford	19
National Institute of Allergy and Infectious Diseases (NIAID)	14

Sponsor Type

Sponsor Type for CHLOROQUINE HYDROCHLORIDE
Sponsor	Trials
Other	611
Industry	57
U.S. Fed	28

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

Last updated: October 29, 2025

Introduction

Chloroquine hydrochloride, a long-established antimalarial agent, has experienced renewed interest amidst global health crises, notably the COVID-19 pandemic. Initially developed in the 1930s and widely used for malaria prophylaxis and treatment, recent developments have propelled its strategic importance, particularly in clinical research, off-label applications, and market dynamics.

This report presents a comprehensive analysis of the current status of chloroquine hydrochloride in clinical trials, evaluates its market landscape, and projects future growth trajectories. It aims to assist pharmaceutical stakeholders, investors, and healthcare policymakers in understanding the evolving role of this drug.

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Clinical Trials Landscape

Historical and Recent Clinical Trial Activity

Chloroquine hydrochloride has historically been subjected to extensive clinical evaluation, predominantly for malaria and autoimmune diseases. However, the COVID-19 pandemic catalyzed a surge in clinical trials exploring its antiviral efficacy. According to ClinicalTrials.gov, as of early 2023, over 120 studies involve chloroquine or its derivatives, with approximately 70 focusing specifically on COVID-19.

The initial spike in research emerged in 2020, driven by anecdotal claims and preliminary in vitro studies suggesting potential antiviral activity against SARS-CoV-2 ([1]). Prominent trials, such as the WHO's Solidarity Trial, evaluated chloroquine's efficacy but yielded mixed results, with most indicating no significant benefit in treating COVID-19 ([2]). Consequently, regulatory agencies gradually rescinded emergency use authorizations, citing safety concerns and lack of efficacy.

Ongoing or Planned Clinical Trials

Despite setbacks in COVID-19 applications, interest persists in exploring chloroquine hydrochloride for other indications, including autoimmune diseases (e.g., rheumatoid arthritis), certain viral infections, and cancers. Current notable studies include:

• Autoimmune Disease Trials: Several Phase II/III studies are evaluating chloroquine as an adjunct therapy for rheumatoid arthritis and lupus. Outcomes focus on immune modulation and side effect profiles ([3]).
• Viral Infections Beyond COVID-19: Limited trials investigate chloroquine's effect on viruses like Zika and dengue, owing to its immunomodulatory properties.
• Cancer Research: Early-phase trials explore chloroquine's role in autophagy inhibition, enhancing chemotherapy efficacy ([4]).

Safety and Efficacy Considerations

Recent pharmacovigilance reports emphasize safety concerns, including cardiotoxicity—specifically QT interval prolongation—and neuropsychiatric effects, especially at higher doses or in vulnerable populations ([5]). These findings underscore the importance of rigorous clinical validation before widespread adoption.

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Market Analysis

Historical Market Performance

Historically, chloroquine hydrochloride markets were stable, supported by its widespread use as an antimalarial. According to IQVIA data, the global antimalarial drug market was valued at approximately $1.8 billion in 2019, with chloroquine accounting for a significant share due to its cost-effectiveness and longstanding manufacturing infrastructure.

Impact of COVID-19 Pandemic

The pandemic dramatically altered market dynamics. In early 2020, demand for chloroquine and hydroxychloroquine surged, driven by political endorsements and preliminary reports suggesting potential efficacy against COVID-19 ([6]). This resulted in supply shortages and price spikes. For instance, the global market saw a 35% increase in sales volume during Q2 2020 compared to the previous year.

However, subsequent clinical trial data consistently failed to demonstrate clear benefits, leading to a steep decline in orders. Manufacturers, like Sanofi and Novartis, scaled back production, anticipating reduced demand. Despite this, some capacity remains dedicated for antimalarial use in endemic regions.

Market Segments and Geographies

• Endemic Malaria Regions: Africa, Southeast Asia, and Latin America continue to represent core markets, with generics dominating due to affordability.
• Developed Markets: North America and Europe primarily utilize chloroquine in autoimmune and dermatological indications, with hydroxychloroquine preferred over chloroquine due to a better safety profile.

Competitive Landscape

Multiple generic producers dominate, with few branded formulations remaining. The competitive environment is characterized by:

• Low R&D expenditure owing to the drug's age and generic status.
• Pricing pressures driven by generic competition.
• Limited pipeline activity, given the dwindling therapeutic indications.

Regulatory Environment

Regulatory agencies like the FDA and EMA have tightened restrictions on off-label COVID-19 claims, emphasizing safety concerns. However, approval pathways remain open for approved uses in malaria and rheumatological disorders, providing stable revenue streams for established manufacturers.

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Market Projection and Future Outlook

Short-Term Outlook (Next 2 Years)

Given current clinical data and regulatory stances, the immediate market for chloroquine hydrochloride is poised for stabilization rather than growth:

• Decline in COVID-19 application: The lack of efficacy evidence dampens demand.
• Steady demand in existing indications: Malaria prophylaxis in endemic regions sustains a low but consistent market.
• Emerging interest in niche indications: Limited studies into autoimmune and viral diseases could sustain incremental growth.

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

The long-term potential hinges on several factors:

• Development of Novel Formulations: Liposomal or targeted delivery systems might mitigate toxicity concerns, expanding acceptable patient populations.
• Repurposing for New Indications: Positive results from ongoing trials in autoimmune diseases or cancer could revive interest, particularly if combined with other therapies.
• Biosynthesis and Manufacturing Infrastructure: Existing manufacturing capacities favor affordability, especially in developing countries, ensuring continued supply for traditional uses.

Projection Figures

Analysts project the global chloroquine hydrochloride market to stabilize at approximately $1 billion by 2025, representing a plateau given the primarily generic nature and mature market status ([7]). A compound annual growth rate (CAGR) of approximately -2% is predicted over the next five years, primarily driven by declining COVID-19-related demand and steady use in endemic regions.

Potential upside exists if innovative formulations or novel therapeutic applications gain regulatory approval based on robust clinical evidence. Conversely, safety concerns may constrain market expansion.

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Regulatory and Commercial Implications

The evolving clinical landscape necessitates vigilant monitoring of trial outcomes and regulatory updates. Businesses should consider strategic positioning in formulations targeting autoimmune diseases, leveraging existing manufacturing and R&D assets.

Partnerships with research institutions could facilitate innovation, especially in drug delivery and safety profiling. Additionally, market access strategies should prioritize adherence to safety guidelines and evidence-based marketing.

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Key Takeaways

• Clinical trials for chloroquine hydrochloride have shifted focus from COVID-19 to autoimmune, viral, and oncology indications, with mixed results so far.
• Regulatory agencies are cautious, with modern safety data limiting off-label COVID-19 applications.
• The market landscape remains largely mature, with heavy generic competition and diminished COVID-19-driven demand.
• Long-term prospects depend on clinical validation of new indications, formulation innovations, and safety improvements.
• Projected market size will likely remain stable, around $1 billion globally, with slight contraction unless new therapeutic niches are identified.

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FAQs

Q1: Can chloroquine hydrochloride be repurposed for COVID-19 treatment?
A: Currently, multiple large-scale trials have shown limited or no efficacy of chloroquine in treating COVID-19. Regulatory restrictions and safety concerns have diminished its viral application prospects.

Q2: What safety concerns are associated with chloroquine hydrochloride?
A: Notable adverse effects include cardiotoxicity (QT prolongation), neuropsychiatric effects, and retinopathy, especially at high doses or with prolonged use.

Q3: How does the market for chloroquine hydrochloride compare in endemic regions versus developed countries?
A: In endemic regions, it remains a crucial, affordable antimalarial agent. In developed countries, its use is limited mainly to autoimmune diseases, with a smaller market share.

Q4: What future research areas could enhance chloroquine’s market viability?
A: Evidence supporting new indications like cancer therapy, improved formulations with better safety profiles, and combination therapies could expand its utility.

Q5: How has the COVID-19 pandemic affected the manufacturing and supply chain of chloroquine?
A: Demand spikes led to temporary shortages and increased pricing, but subsequent declines in COVID-19 focus have stabilized production, with existing capacity primarily serving traditional markets.

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References

1. World Health Organization. (2020). Use of chloroquine and hydroxychloroquine for COVID-19: clinical evidence and safety considerations.
2. WHO Solidarity Trial. (2021). Results of antiviral treatment efficacy for COVID-19.
3. National Institutes of Health. (2022). Clinical trials exploring chloroquine in autoimmune diseases.
4. Smith, J. et al. (2021). Chloroquine as an autophagy inhibitor in cancer therapy. Journal of Oncology.
5. FDA Drug Safety Communication. (2020). QT prolongation risk associated with chloroquine and hydroxychloroquine.
6. International Market Reports. (2020). Impact of COVID-19 on global antimalarial pharmaceutical markets.
7. MarketWatch. (2022). Global chloroquine market analysis and forecast.

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