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.
NCT00084240 ↗	Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia	Terminated	Pfizer	Phase 2/Phase 3	2004-03-01	The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.

Clinical Trial Conditions for Chloroquine Hydrochloride

Condition Name

Condition Name for Chloroquine Hydrochloride
Intervention	Trials
Malaria	69
COVID-19	50
Vivax Malaria	19
Malaria, Vivax	15

Condition MeSH

Condition MeSH for Chloroquine Hydrochloride
Intervention	Trials
Malaria	145
COVID-19	86
Malaria, Vivax	44
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	19
India	19

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
Phase 4	60
Phase 3	74
Phase 2/Phase 3	33

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	607
Industry	56
U.S. Fed	28

Chloroquine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Chloroquine Hydrochloride

Chloroquine hydrochloride, along with its derivative hydroxychloroquine, has been a subject of significant interest and controversy, particularly during the COVID-19 pandemic. Originally used to treat malaria and certain autoimmune diseases, these drugs were repurposed in an attempt to combat the novel coronavirus.

Clinical Trials Update

The RECOVERY Trial

One of the most pivotal clinical trials involving hydroxychloroquine was the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial conducted in the UK. This trial, which enrolled over 11,000 patients from 175 NHS hospitals, aimed to evaluate various potential treatments for COVID-19, including hydroxychloroquine. The results, announced on June 5, 2020, showed no clinical benefit from the use of hydroxychloroquine in hospitalized patients with COVID-19. The trial found that 25.7% of patients treated with hydroxychloroquine died after 28 days, compared to 23.5% of those receiving standard care, leading to the conclusion that there was no meaningful mortality benefit from the drug[1][4].

Other Significant Trials

Other large-scale trials also yielded disappointing results. For instance, two studies involving people exposed to the virus and at risk of infection, and another involving severely ill patients, showed no benefit from hydroxychloroquine. These findings, combined with earlier smaller trials, led many scientists to advocate for the cessation of most ongoing trials involving hydroxychloroquine for COVID-19 treatment[4].

Impact on Ongoing Research

The lack of efficacy in these trials has significant implications for ongoing research. The World Health Organization (WHO) was likely to end the hydroxychloroquine arm of its Solidarity trial following these results. Continuing trials with hydroxychloroquine may divert resources away from testing more promising treatments, potentially denying patients the opportunity to receive more effective care[4].

Market Analysis

Market Growth and COVID-19 Impact

The COVID-19 pandemic dramatically impacted the market for anti-malarial drugs, including chloroquine and hydroxychloroquine. Despite the lack of clinical evidence supporting their use against COVID-19, these drugs saw a surge in demand due to early observational studies suggesting antiviral effectiveness. This led to Emergency Use Authorizations (EUAs) in many countries, resulting in increased prescriptions and market expansion[2][3].

Market Size and Projections

The global market for hydroxychloroquine and chloroquine is projected to experience significant growth. By 2031, the market is expected to reach a valuation of USD 1120.41 billion, growing at a CAGR of 102.57% from 2024-2031. This growth is driven by several factors, including the rising number of malaria cases, increasing prevalence of autoimmune diseases like lupus and rheumatoid arthritis, and the aging global population[3].

Segment Analysis

The market is segmented by type, application, and region. The injectable segment is showing substantial growth due to its faster onset of action, making it ideal for emergency medical circumstances. This segment is particularly popular in hospitals and emergency rooms for treating severe cases of malaria, autoimmune diseases, and potential COVID-19 complications[3].

Regional and Application-Specific Growth

The demand for chloroquine and hydroxychloroquine varies by region and application. In malaria-prone areas, government initiatives to improve access to antimalarial drugs are driving market growth. Additionally, the use of these drugs in treating autoimmune diseases and their potential in COVID-19 treatment, despite the lack of strong evidence, continue to influence market dynamics[3][5].

Therapeutic Advantages and Utilization

Emergency and Hospital Settings

Injectable formulations of hydroxychloroquine and chloroquine offer significant therapeutic benefits, particularly in emergency settings. Their faster onset of action compared to oral tablets makes them crucial for immediate treatment in hospitals and emergency rooms[3].

Research and Development

The use of these drugs in clinical trials and research studies continues to advance the understanding and application of these medications in various therapeutic areas. This ongoing research investment is a key driver of market growth and expansion[3].

Pandemic Response and Global Interest

Early Observational Studies and EUAs

The COVID-19 pandemic prompted global interest in hydroxychloroquine and chloroquine as potential remedies. Early observational studies suggesting antiviral effectiveness led to EUAs, resulting in a significant increase in prescriptions and market expansion. However, subsequent large-scale trials have largely diminished hopes for these drugs as effective treatments for COVID-19[2][3].

Regulatory and Public Health Implications

The regulatory landscape has been complex, with many trials halted and resumed based on safety concerns and data reviews. The retraction of a controversial Lancet paper claiming increased mortality rates with hydroxychloroquine use further complicated the regulatory environment[4].

Key Takeaways

• Clinical Efficacy: Large-scale clinical trials, including the RECOVERY trial, have shown no significant benefit of hydroxychloroquine in treating COVID-19.
• Market Growth: Despite the lack of clinical efficacy, the market for hydroxychloroquine and chloroquine is expected to grow significantly, driven by demand for malaria treatment, autoimmune disease management, and ongoing research.
• Therapeutic Advantages: Injectable formulations offer faster onset of action, making them valuable in emergency and hospital settings.
• Pandemic Impact: The COVID-19 pandemic led to a surge in demand and market expansion, although this has been tempered by subsequent clinical trial results.

FAQs

What were the findings of the RECOVERY trial regarding hydroxychloroquine?

The RECOVERY trial found no clinical benefit from the use of hydroxychloroquine in hospitalized patients with COVID-19, leading to the cessation of the hydroxychloroquine arm of the trial[1][4].

How has the COVID-19 pandemic impacted the market for chloroquine and hydroxychloroquine?

The pandemic led to a significant increase in demand for these drugs due to early observational studies suggesting antiviral effectiveness, resulting in market expansion despite later trials showing no benefit[2][3].

What are the projected market valuations for hydroxychloroquine and chloroquine?

The global market for hydroxychloroquine and chloroquine is projected to reach USD 1120.41 billion by 2031, growing at a CAGR of 102.57% from 2024-2031[3].

What are the therapeutic advantages of injectable formulations of hydroxychloroquine and chloroquine?

Injectable formulations offer a faster onset of action compared to oral tablets, making them ideal for emergency medical circumstances and hospital settings[3].

How have regulatory agencies responded to the use of hydroxychloroquine and chloroquine for COVID-19?

Regulatory agencies have issued EUAs and later reviewed safety data, leading to the halt and resumption of various clinical trials. The WHO is likely to end the hydroxychloroquine arm of its Solidarity trial following negative results from large-scale studies[4].

Sources

1. RECOVERY Trial: "Statement from the Chief Investigators of the Randomised Evaluation of COVID-19 Therapy RECOVERY Trial on Hydroxychloroquine," Recovery Trial, June 5, 2020.
2. Mordor Intelligence: "Anti-Malarial Drugs Market - Share & Size - Mordor Intelligence," Mordor Intelligence.
3. Verified Market Research: "In-Depth Industry Outlook: Hydroxychloroquine And Chloroquine Market," Verified Market Research.
4. Science: "Three big studies dim hopes that hydroxychloroquine can treat or prevent COVID-19," Science, June 2020.
5. OpenPR: "Chloroquine Phosphate Tablets (COVID-19) Market Development Strategy Report 2024: Expanding Reach and Impact," OpenPR.