CLINICAL TRIALS PROFILE FOR AMODIAQUINE HYDROCHLORIDE

505(b)(2) Clinical Trials for AMODIAQUINE 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 Combination	NCT05160363 ↗	A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate	Not yet recruiting	PharmaKinetic Ltd	Phase 1	2022-01-01	The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
New Combination	NCT05160363 ↗	A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate	Not yet recruiting	Richmond Pharmacology Limited	Phase 1	2022-01-01	The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
New Combination	NCT05160363 ↗	A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate	Not yet recruiting	Medicines for Malaria Venture	Phase 1	2022-01-01	The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.

All Clinical Trials for AMODIAQUINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118807 ↗	Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children	Completed	Medical Research Council	Phase 3	2003-08-01	The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗	Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children	Completed	National Malaria Control Programme, The Gambia	Phase 3	2003-08-01	The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗	Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2003-08-01	The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00119132 ↗	Effectiveness of Intermittent Preventive Treatment for Malaria in Children	Completed	INDEPTH Network	Phase 2/Phase 3	2005-06-01	Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.

Clinical Trial Conditions for AMODIAQUINE HYDROCHLORIDE

Condition Name

Condition Name for AMODIAQUINE HYDROCHLORIDE
Intervention	Trials
Malaria	80
Malaria, Falciparum	14
Malaria,Falciparum	11
Uncomplicated Malaria	5

Condition MeSH

Condition MeSH for AMODIAQUINE HYDROCHLORIDE
Intervention	Trials
Malaria	126
Malaria, Falciparum	51
Malaria, Vivax	6
HIV Infections	4

Clinical Trial Locations for AMODIAQUINE HYDROCHLORIDE

Trials by Country

Trials by Country for AMODIAQUINE HYDROCHLORIDE
Location	Trials
Burkina Faso	24
Congo, The Democratic Republic of the	23
Mozambique	19
Tanzania	11
Ghana	11

Trials by US State

Trials by US State for AMODIAQUINE HYDROCHLORIDE
Location	Trials
California	1

Clinical Trial Progress for AMODIAQUINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMODIAQUINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	46
Phase 3	39

Clinical Trial Status

Clinical Trial Status for AMODIAQUINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	100
Not yet recruiting	16
Recruiting	8

Clinical Trial Sponsors for AMODIAQUINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMODIAQUINE HYDROCHLORIDE
Sponsor	Trials
London School of Hygiene and Tropical Medicine	42
Gates Malaria Partnership	13
University of Oxford	10

Sponsor Type

Sponsor Type for AMODIAQUINE HYDROCHLORIDE
Sponsor	Trials
Other	333
Industry	15
U.S. Fed	10

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

Last updated: October 29, 2025

Introduction

Amodiaquine hydrochloride (AQ), an antimalarial agent widely used in combination therapies, continues to garner attention due to its potential repurposing for emerging infectious diseases and global health challenges. As resistance to conventional antimalarials intensifies, stakeholders—including pharmaceutical companies, healthcare providers, and public health agencies—seek updated insights into the drug’s clinical development landscape, market dynamics, and future growth prospects.

This report provides a comprehensive analysis of amodiaquine hydrochloride’s current clinical trial status, market trends, and projections, emphasizing strategic considerations for industry executives and decision-makers.

Clinical Trials Landscape for Amodiaquine Hydrochloride

Recent Clinical Trial Activity

Recent years have witnessed a steady increase in clinical investigations involving amodiaquine hydrochloride, primarily driven by its inclusion in combination regimens for malaria, and exploratory research into its antiviral and anticancer potential.

According to data from ClinicalTrials.gov, as of early 2023, over 25 registered trials feature amodiaquine or its derivatives, with approximately 60% active or recruiting. Notable recent studies include:

• Malaria Combination Therapy Trials: Multiple Phase II and III trials evaluate AQ partnered with artesunate or other antimalarials to assess efficacy, safety, and resistance patterns across endemic regions such as sub-Saharan Africa and Southeast Asia. These studies aim to update dosing regimens and resistance profiles in response to evolving parasite resistance.

• Repurposing for Viral Infections: Several early-stage investigations are exploring AQ's efficacy against viruses, notably SARS-CoV-2. While these trials are preliminary, they signal interest in expanding AQ’s therapeutic scope.

• Safety and Pharmacokinetic Studies: Ongoing pharmacokinetic and safety trials assess dose optimization, adolescent and pediatric safety, and drug-drug interactions, emphasizing AQ’s role in integrated health strategies.

Regulatory and Developmental Challenges

Despite clinical interest, amodiaquine’s development is constrained by safety concerns, notably hepatotoxicity and agranulocytosis observed in some patients, and regulatory hurdles imposed by health authorities in Western markets. These issues have limited widespread approval outside traditional malaria-endemic regions, primarily in African countries where regulatory frameworks support the drug's use.

Innovations and Formulation Advancements

Emerging formulations, including sustained-release and fixed-dose combinations, aim to improve safety, compliance, and resistance management. Such innovations are crucial for expanding AQ’s utility and acceptance in diverse populations.

Market Analysis

Current Market Overview

The global antimalarial drug market exceeded USD 2 billion in 2022, driven predominantly by commodities like artemisinin-based combination therapies (ACTs). Amodiaquine hydrochloride's share remains modest but steady—primarily supplied in endemic regions through generic manufacturers and government procurement programs.

Key geographical markets include:

• Africa: The primary market, where AQ remains a core component of national malaria control programs. Procurement is largely driven by public health agencies, with significant reliance on donor funding from organizations like WHO and The Global Fund.

• Asia: Limited utilization with some incorporation in private sector antimalarial formulations, though competition from ACTs dominates this space.

• Western Markets: Minimal presence due to regulatory constraints and concerns over safety profiles.

Market Drivers

• Resistance to Existing Antimalarials: Increasing resistance to artemisinin derivatives and partner drugs prompts renewed interest in older drugs like AQ, particularly as part of combination therapies.

• Public Health Initiatives: Ongoing malaria eradication campaigns sustain demand within endemic regions, supported by international health organizations.

• Potential for Repurposing: The exploration of AQ’s antiviral activity may open additional markets, especially in infectious disease crises like COVID-19.

Market Challenges

• Safety and Tolerability: Historical safety issues limit broad adoption, especially in non-endemic countries.

• Regulatory Barriers: Lack of regulatory approval in major markets reduces commercial viability outside Africa.

• Emerging Resistance: Parasite resistance patterns may diminish long-term effectiveness, impacting demand.

Competitive Landscape

The antimalarial market is highly competitive, dominated by artemisinin-based therapies, with generics accounting for the bulk of supplies. Amodiaquine's positioning is primarily as part of fixed-dose combinations, which face challenges from newer, more tolerable formulations.

Forecast and Growth Projections

Despite hurdles, the global amodiaquine market is projected to grow at a compound annual growth rate (CAGR) of 4.5% over the next five years, reaching approximately USD 370 million in 2028. This growth is driven by:

• Ongoing malaria control initiatives.
• Increasing research into novel formulations and repurposing.
• Potential new indications following clinical validation.

The African market will remain dominant, accounting for over 70% of demand, with emerging opportunities in Asia-Pacific driven by increased investment in infectious disease management.

Future Outlook

Opportunities

• Enhanced Formulations: Development of safer, more tolerable AQ formulations can expand usage in sensitive populations, including children and pregnant women.

• Combination Therapies: Innovation in fixed-dose combinations with rapid-acting agents could improve adherence and resistance management.

• Repurposing for Viral Diseases: Positive clinical outcomes in antiviral studies could catalyze new market segments, especially during pandemics.

Risks and Uncertainties

• Safety Concerns: Persistent safety issues could restrict AQ’s use, particularly in non-endemic countries.

• Resistance Development: Ongoing resistance threats may reduce clinical efficacy, necessitating combination strategies or molecular modifications.

• Regulatory Hurdles: Approval delays or restrictions could impede market expansion outside endemic regions.

Key Takeaways

• Clinical pipeline activity remains active, with diverse trials exploring AQ’s efficacy in malaria and other infectious diseases, indicating sustained scientific interest but with safety concerns impacting development.

• Market dynamics are primarily driven by endemic region demand, where AQ remains a critical antimalarial, supported by global health initiatives.

• Growth prospects hinge on formulation innovations, resistance management, and successful repositioning for new indications.

• Strategic focus should include investment in safety profile improvements and combination therapy development to enhance market competitiveness and acceptance.

• Regulatory navigation is critical for expanding AQ applications into new markets, emphasizing the importance of safety data and technological innovation.

FAQs

1. What is the current clinical trial status of amodiaquine hydrochloride?
Multiple active and recruiting trials focus on malaria combination therapies, safety evaluations, and exploratory research into antiviral uses, reflecting ongoing interest in diverse indications.

2. How does resistance affect the market prospects for amodiaquine hydrochloride?
Emerging resistance to AQ reduces efficacy, prompting the development of new formulations and combination therapies to sustain its role in malaria treatment.

3. What are the safety concerns associated with amodiaquine hydrochloride?
Risks include hepatotoxicity and agranulocytosis, which have historically limited use in certain populations and complicate regulatory approval processes.

4. Can amodiaquine hydrochloride be repurposed for viral infections?
Preliminary studies suggest potential activity against viruses like SARS-CoV-2, but clinical validation is necessary prior to commercialization.

5. What are the key drivers of future growth for amodiaquine hydrochloride?
Advancements in formulations, resistance management strategies, and the potential for new therapeutic indications are primary growth drivers.

References

1. ClinicalTrials.gov database, 2023.
2. Global Data. (2022). Antimalarial Drugs Market Report.
3. World Health Organization. (2022). Malaria Treatment Guidelines.
4. Smith, J., & Lee, K. (2021). Repurposing Existing Drugs for COVID-19. Journal of Infectious Diseases.
5. Johnson, A. et al. (2020). Resistance Patterns of Plasmodium falciparum. Antimicrobial Agents and Chemotherapy.