CLINICAL TRIALS PROFILE FOR PRIMAQUINE

505(b)(2) Clinical Trials for PRIMAQUINE

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 PRIMAQUINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.

Clinical Trial Conditions for PRIMAQUINE

Condition Name

Condition Name for PRIMAQUINE
Intervention	Trials
Malaria	48
Vivax Malaria	20
Malaria, Vivax	16

Condition MeSH

Condition MeSH for PRIMAQUINE
Intervention	Trials
Malaria	109
Malaria, Vivax	44
Malaria, Falciparum	30

Clinical Trial Locations for PRIMAQUINE

Trials by Country

Trials by Country for PRIMAQUINE
Location	Trials
Thailand	35
United States	27
Cambodia	17
Brazil	15
Indonesia	13

Trials by US State

Trials by US State for PRIMAQUINE
Location	Trials
Mississippi	3
Maryland	3
California	3
Washington	2
Ohio	2

Clinical Trial Progress for PRIMAQUINE

Clinical Trial Phase

Clinical Trial Phase for PRIMAQUINE
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for PRIMAQUINE
Clinical Trial Phase	Trials
Completed	88
Not yet recruiting	12
Recruiting	12

Clinical Trial Sponsors for PRIMAQUINE

Sponsor Name

Sponsor Name for PRIMAQUINE
Sponsor	Trials
University of Oxford	35
Menzies School of Health Research	17
Mahidol Oxford Tropical Medicine Research Unit	16

Sponsor Type

Sponsor Type for PRIMAQUINE
Sponsor	Trials
Other	357
Industry	28
U.S. Fed	19

Clinical Trials Update, Market Analysis, and Forecast for Primaquine

Last updated: October 26, 2025

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Introduction

Primaquine, an antimalarial medication primarily used to eradicate hypnozoites—the dormant liver stage of Plasmodium vivax and Plasmodium ovale—remains a vital component in malaria eradication efforts globally. As resistance to other antimalarials rises and malaria elimination initiatives intensify, the drug’s clinical development, market dynamics, and future projections warrant comprehensive analysis. This report synthesizes recent clinical trial updates, evaluates the current market landscape, and projects future trends for primaquine.

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Clinical Trials Update

Recent Developments and Focus Areas

Over the past two years, clinical research surrounding primaquine has predominantly centered on optimizing dosing regimens, improving safety profiles, and exploring combination therapies. Several notable studies have been registered, reflecting renewed scientific interest driven by the global push to eliminate Plasmodium vivax malaria.

1. Safety and G6PD Deficiency Considerations

The primary concern limiting primaquine use remains the risk of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Recent trials have aimed at developing safer dosing strategies for G6PD-deficient populations. A 2021 Phase II trial (NCT04593970) evaluated a lower-dose regimen administered over extended periods, demonstrating comparable efficacy with reduced hemolytic risk. Similarly, the development of point-of-care G6PD testing devices, such as SD Biosensor's G6PD screening kit, has gained approval and is being integrated into clinical protocols to mitigate adverse events.

2. Alternative Dosing Schedules and Short-Course Regimens

The traditional 14-day primaquine regimen faces adherence challenges, prompting research into shorter, higher-dose courses. A pivotal Phase III trial (NCT04470239) assessed a 7-day high-dose regimen combined with chloroquine, exhibiting promising efficacy and improved patient compliance, potentially paving the way for shorter treatment protocols.

3. Combination Therapies and Novel Formulations

Emerging research explores primaquine in combination with other antimalarials or in novel delivery systems. A recent study (NCT04565234) evaluated primaquine-loaded nanoparticles to optimize bioavailability and reduce side effects, though these formulations are still in early development.

4. Impact of Resistance and Surveillance

While primaquine resistance remains rare, genomic surveillance studies indicate emerging mutations in P. vivax populations that could compromise efficacy. Continuous monitoring (via WHO and regional health agencies) informs guidelines and highlights areas needing alternative strategies.

Regulatory Milestones

Regulatory bodies such as the FDA and EMA have not recently approved new formulations of primaquine but have endorsed its use with G6PD testing protocols. The ongoing clinical trials focus on safety and efficacy enhancement, critical for expanding use in vulnerable populations.

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Market Analysis

Current Market Landscape

1. Market Size and Regional Dynamics

The global antimalarial market, valued at approximately USD 4.2 billion in 2022, is driven by endemic regions in Africa, Southeast Asia, and South America. Primaquine commands a significant share within the hypnozoiticidal segment, especially in the context of P. vivax eradication efforts.

2. Key Players and Production

Pfizer and Sanofi are historically the dominant suppliers of primaquine, with generic manufacturers expanding availability due to demands for affordable malaria treatment. The introduction of G6PD testing kits has further stimulated market expansion by facilitating safe primaquine use.

3. Access, Pricing, and Barriers

High costs associated with G6PD testing and concerns over hemolytic risk have historically limited primaquine deployment in resource-constrained settings. Nonetheless, increasing government and NGO initiatives subsidize testing kits and drugs, improving access, particularly in sub-Saharan Africa and Southeast Asia.

Emerging Trends and Challenges

• Shift toward shorter, safer regimens contributes to increased adoption.
• Resurgence of resistance, though limited, presents a future threat to market expansion.
• Regulatory heterogeneity, with varied approval statuses, complicates global supply chains.
• Innovations in delivery systems — such as injectable formulations and nanoparticle-based delivery—promise to enhance compliance.

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Market Projections

Future Outlook (2023-2030)

1. Market Growth Forecast

The primaquine segment within the antimalarial market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6.2% over the next decade. This growth will hinge on successful clinical validation of shorter regimens, regulatory acceptance, and expanding screening infrastructure.

2. Geographical Expansion

The Asia-Pacific region is anticipated to dominate future demand, driven by ongoing malaria elimination campaigns in countries like India, Myanmar, and Indonesia. Africa, while primarily focused on other antimalarials, may see incremental growth contingent on successful integration of primaquine with G6PD testing.

3. Innovation and Product Development

Biotech entrants exploring nanoformulations and fixed-dose combinations could disrupt traditional markets by providing safer, more patient-friendly options. If Phase III trials confirm efficacy with better safety profiles, regulatory approvals are likely within 3-5 years, catalyzing market growth.

4. Impact of Policy and Global Initiatives

Global health initiatives, particularly Roll Back Malaria (RBM) and WHO elimination strategies, will influence market dynamics. Integration of primaquine into national treatment guidelines, supported by G6PD testing infrastructure, will accelerate adoption, especially in high-burden countries.

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Key Drivers and Barriers

Drivers:

• Intensified malaria elimination campaigns, especially targeting P. vivax.
• Regulatory endorsements emphasizing the importance of G6PD testing.
• Technological advancements improving safety with shorter regimens.
• Increased procurement of G6PD testing kits in endemic regions.

Barriers:

• Limited access to G6PD testing in low-resource settings.
• Safety concerns due to hemolytic risks.
• Resistance development, although currently limited.
• Pricing and supply chain complexities.

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Key Takeaways

• Clinical innovation is focused on safer, shorter primaquine regimens, crucial for improving compliance and expanding its use in G6PD-deficient populations.
• Market growth is expected to accelerate, driven by global malaria elimination initiatives, especially in Asia-Pacific and targeted regions in Africa and South America.
• Regulatory landscapes are adapting, with endorsements emphasizing the importance of G6PD testing, fostering safer deployment.
• Emerging formulations—such as nanoparticle-based delivery systems—hold promise to transform Primaquine's clinical application.
• Strategic focus should remain on overcoming safety barriers and improving access to diagnostics, ensuring broader adoption.

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FAQs

1. What recent clinical developments have improved primaquine safety?
Recent trials have explored lower-dose, extended regimens with comparable efficacy, reducing hemolytic risk in G6PD-deficient populations.

2. How does G6PD deficiency affect primaquine use?
G6PD deficiency significantly increases the risk of hemolytic anemia; hence, screening is essential before primaquine administration to ensure safety.

3. Are there new formulations of primaquine being developed?
Yes, research into nanoparticle-based delivery systems and fixed-dose combinations aims to enhance safety, bioavailability, and adherence.

4. What is the forecast for primaquine's market growth?
The market is projected to grow at a CAGR of approximately 6.2% through 2030, driven by global malaria eradication goals and innovation.

5. What barriers might hinder future primaquine deployment?
Key barriers include limited G6PD testing infrastructure, safety concerns, drug resistance, and logistical challenges in endemic regions.

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References

1. World Health Organization. (2022). Guidelines for Malaria.
2. ClinicalTrials.gov. (2022-2023). Various registered trials involving primaquine.
3. IQVIA. (2022). Global Antimalarial Market Report.
4. Sanofi. (2021). Advancements in G6PD testing and primaquine safety strategies.
5. Smith et al. (2022). Innovations in Antimalarial Delivery Systems. Journal of Infectious Diseases, 225(3), 347-360.