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.
NCT00000717 ↗	The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the safety and effectiveness of clindamycin and primaquine in the treatment of mild Pneumocystis carinii pneumonia (PCP) in AIDS patients. As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP and side effects may be less.
NCT00076323 ↗	A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency	Completed	Walter Reed Army Institute of Research (WRAIR)	N/A	2003-12-01	This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.

Clinical Trial Conditions for Primaquine

Condition Name

Condition Name for Primaquine
Intervention	Trials
Malaria	46
Vivax Malaria	20
Malaria, Vivax	15
Healthy	8

Condition MeSH

Condition MeSH for Primaquine
Intervention	Trials
Malaria	107
Malaria, Vivax	41
Malaria, Falciparum	30
Glucosephosphate Dehydrogenase Deficiency	8

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
Maryland	3
California	3
Mississippi	3
Indiana	2
Illinois	2

Clinical Trial Progress for Primaquine

Clinical Trial Phase

Clinical Trial Phase for Primaquine
Clinical Trial Phase	Trials
Phase 4	38
Phase 3	24
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Primaquine
Clinical Trial Phase	Trials
Completed	87
Not yet recruiting	12
Unknown status	11

Clinical Trial Sponsors for Primaquine

Sponsor Name

Sponsor Name for Primaquine
Sponsor	Trials
University of Oxford	35
Mahidol Oxford Tropical Medicine Research Unit	16
London School of Hygiene and Tropical Medicine	16

Sponsor Type

Sponsor Type for Primaquine
Sponsor	Trials
Other	331
Industry	23
U.S. Fed	19

Primaquine: Clinical Trials, Market Analysis, and Projections

Introduction to Primaquine

Primaquine is an antimalarial drug that has been a cornerstone in the treatment and prevention of malaria, particularly for its ability to target the dormant liver stages (hypnozoites) of Plasmodium vivax and Plasmodium ovale. Here, we will delve into recent clinical trials, market analysis, and future projections for this crucial medication.

Recent Clinical Trials

High-Dose Short-Course Primaquine for P. vivax Malaria

A significant clinical trial, the IMPROV (Improving the Radical Cure of Vivax Malaria) trial, has shown promising results for a shorter treatment regimen of primaquine. This multicentre trial, involving over 2,000 patients in Ethiopia, Afghanistan, Indonesia, and Vietnam, tested the efficacy of a 7-day high-dose course of primaquine compared to the traditional 14-day course.

• Efficacy and Tolerability: The study found that the 7-day high-dose course was as effective as the 14-day treatment in preventing relapses of P. vivax malaria. The regimen was well tolerated, with few minor side effects reported[3].
• Adherence: The shorter regimen improved adherence, as patients were more likely to complete the treatment once they felt better, reducing the likelihood of multiple episodes of malaria[3].

Another trial published in The Lancet also highlighted the safety and efficacy of high-dose short-course primaquine in patients with P. falciparum malaria, showing a significant reduction in the risk of subsequent P. vivax parasitaemia within 63 days[1].

Market Analysis

Market Size and Growth

The primaquine market is expected to grow significantly from 2024 to 2031, driven by several key factors:

• Increasing Malaria Incidence: The rising incidence of malaria, especially in tropical and subtropical regions, is a major driver. Malaria remains a leading cause of morbidity and mortality, necessitating effective treatments[2].
• Government Initiatives and Funding: Government and NGO funding, along with technological advancements in drug development and diagnostic technologies, are boosting the demand for primaquine[2].
• Healthcare Expenditure: Increased healthcare expenditure globally is also contributing to the growth of the primaquine market[2].

Market Segmentation

By Disease Indication

• Malaria: The primary indication for primaquine, which includes both P. vivax and P. falciparum.
• Pneumocystis Pneumonia (PCP): Primaquine is also used in the treatment of PCP.
• Leprosy: Another therapeutic application, though less common.
• Others: Includes other rare indications[2].

By End-User

• Hospitals: Primary end-users due to their specialized resources and personnel.
• Clinics: Also significant, especially for outpatient treatment.
• Home Healthcare: Growing segment, particularly for follow-up care and adherence monitoring[2].

Geographical Segmentation

• North America and Europe: High demand due to advanced healthcare infrastructure and travel-related cases.
• Asia-Pacific: Large share of malaria prevalence, driving increased consumption.
• Middle East and Africa: Endemic regions with unique demands driven by public health interventions.
• Latin America: Faces challenges with malaria outbreaks, necessitating effective treatment methods[2].

Key Players

The primaquine market is dominated by several major pharmaceutical companies:

• Cyper Pharma
• Santa Cruz Biotechnology
• Pfizer
• Summit Medical Group
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Sanofi
• GlaxoSmithKline plc
• Cipla Inc.
• Ipca Laboratories Ltd[2].

Technological Advancements and Innovations

Technological progress is crucial in enhancing the efficacy and safety profiles of primaquine:

• Formulation Techniques: Innovations in formulation improve the drug’s action against various malaria strains.
• Diagnostic Technologies: Quicker and more accurate malaria detection enables timely primaquine administration.
• Pharmacokinetics: Ongoing research to optimize the drug’s action and reduce side effects[2].

Future Projections

Market Growth

The primaquine market is projected to grow significantly from 2024 to 2031, driven by increasing malaria incidence, government initiatives, and technological advancements. The market size is expected to expand as more countries adopt radical cure strategies involving primaquine[2][5].

Clinical Implications

The adoption of high-dose short-course primaquine regimens is expected to become more widespread, given their efficacy and improved adherence rates. This could significantly reduce the burden of P. vivax malaria, particularly in regions where it is endemic[1][3].

Public Health Impact

The use of primaquine as part of universal radical cure strategies has the potential to substantially reduce the incidence of malaria. This approach, combined with other antimalarial treatments and public health measures, could accelerate the elimination of P. vivax malaria from high-prevalence regions[1][3].

Key Takeaways

• Clinical Trials: Recent trials have shown that high-dose short-course primaquine regimens are effective and well-tolerated, improving adherence and reducing relapse rates.
• Market Growth: The primaquine market is expected to grow significantly from 2024 to 2031, driven by increasing malaria incidence and technological advancements.
• Public Health Impact: The adoption of primaquine in radical cure strategies could significantly reduce the burden of P. vivax malaria and accelerate its elimination.

FAQs

What is the primary use of primaquine in malaria treatment?

Primaquine is primarily used to target the dormant liver stages (hypnozoites) of Plasmodium vivax and Plasmodium ovale, preventing relapses of malaria.

What are the recent findings on high-dose short-course primaquine regimens?

Recent clinical trials have shown that high-dose short-course primaquine regimens are as effective as traditional 14-day courses in preventing relapses and are better tolerated, improving adherence rates[1][3].

Which regions are driving the demand for primaquine?

The Asia-Pacific region, Middle East, Africa, and Latin America are driving the demand due to high malaria prevalence and public health interventions[2].

Who are the key players in the primaquine market?

Major players include Cyper Pharma, Santa Cruz Biotechnology, Pfizer, Novartis AG, F. Hoffmann-La Roche Ltd, Sanofi, GlaxoSmithKline plc, Cipla Inc., and Ipca Laboratories Ltd[2].

What are the technological advancements impacting the primaquine market?

Innovations in formulation techniques, diagnostic technologies, and pharmacokinetics are enhancing the efficacy and safety profiles of primaquine, contributing to market growth[2].

Sources

1. The Lancet: "Primaquine radical cure in patients with Plasmodium falciparum malaria: a multicentre, open-label, superiority randomised controlled trial"[1].
2. Verified Market Research: "Primaquine Market Size, Scope, Growth, Trends and Forecast"[2].
3. Tropical Medicine Research: "New study shows faster way to cure vivax malaria"[3].
4. GSK Study Register: "Efficacy and safety study of tafenoquine (TQ) co-administered with an ACT"[4].
5. Cognitive Market Research: "Primaquine Market Report 2024 (Global Edition)"[5].