CLINICAL TRIALS PROFILE FOR PRIMAQUINE PHOSPHATE

All Clinical Trials for Primaquine Phosphate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	HealthNet TPO	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	Gates Malaria Partnership	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗	Eight Week Primaquine Regimen for the Treatment of Vivax Malaria	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2004-04-01	Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00440999 ↗	Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria	Completed	Shin Poong Pharmaceuticals	Phase 3	2007-03-01	The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
NCT00440999 ↗	Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria	Completed	Medicines for Malaria Venture	Phase 3	2007-03-01	The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.

Clinical Trial Conditions for Primaquine Phosphate

Condition Name

Condition Name for Primaquine Phosphate
Intervention	Trials
Malaria	13
Vivax Malaria	6
Malaria, Vivax	5
Healthy	5

Condition MeSH

Condition MeSH for Primaquine Phosphate
Intervention	Trials
Malaria	27
Malaria, Vivax	14
Malaria, Falciparum	5
Glucosephosphate Dehydrogenase Deficiency	5

Clinical Trial Locations for Primaquine Phosphate

Trials by Country

Trials by Country for Primaquine Phosphate
Location	Trials
Thailand	13
Brazil	7
Indonesia	6
Vietnam	4
Afghanistan	4

Trials by US State

Trials by US State for Primaquine Phosphate
Location	Trials
Mississippi	1
California	1

Clinical Trial Progress for Primaquine Phosphate

Clinical Trial Phase

Clinical Trial Phase for Primaquine Phosphate
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	9
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Primaquine Phosphate
Clinical Trial Phase	Trials
Completed	29
Not yet recruiting	6
Unknown status	2

Clinical Trial Sponsors for Primaquine Phosphate

Sponsor Name

Sponsor Name for Primaquine Phosphate
Sponsor	Trials
University of Oxford	14
London School of Hygiene and Tropical Medicine	8
Mahidol Oxford Tropical Medicine Research Unit	4

Sponsor Type

Sponsor Type for Primaquine Phosphate
Sponsor	Trials
Other	94
Industry	4
U.S. Fed	2

Primaquine Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction to Primaquine Phosphate

Primaquine phosphate is a crucial antimalarial drug, particularly effective against the liver stages of Plasmodium vivax malaria. It is the only widely available drug that can eliminate the dormant hypnozoites in the liver, preventing recurrent bouts of malaria. Here, we will delve into recent clinical trials, market analysis, and future projections for primaquine phosphate.

Recent Clinical Trials

Adaptive Pharmacometric Study in G6PD Deficiency

A recent adaptive pharmacometric study conducted in Thailand aimed to characterize the relationship between primaquine dose and haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. This study was designed to identify safer primaquine regimens for G6PD-deficient patients. The trial involved healthy male volunteers and used an iterative adaptive approach to adjust the primaquine dosing regimens based on haemoglobin changes and safety evaluations. The study's primary goal was to balance the need for a radical curative dose of primaquine with the minimization of haemolysis[1].

High-Dose 7-Day Primaquine Regimen

A large clinical trial, the IMPROV (Improving the Radical Cure of Vivax Malaria) trial, tested the efficacy and tolerability of a high-dose 7-day course of primaquine in over 2,000 patients across Africa and Asia. This study found that the 7-day regimen was as effective as the traditional 14-day treatment in preventing relapses of P. vivax malaria. The shorter regimen was well tolerated, with few patients experiencing another episode of malaria within 12 months. This finding is significant as it addresses the issue of poor adherence to the longer treatment regimen[3].

Tolerability and Safety in Children

Another study focused on the tolerability and safety of primaquine in children with uncomplicated P. vivax malaria. The study evaluated different daily doses of primaquine (low, intermediate, and high) and assessed gastrointestinal symptoms, haemoglobin decrease, and serious adverse events. This research is crucial for understanding the safety profile of primaquine in pediatric populations[4].

Market Analysis

Market Size and Growth

The primaquine phosphate API market has witnessed significant growth in recent years and is projected to continue this trend from 2023 to 2031. The market size is expected to expand substantially, driven by the increasing incidence of malaria, particularly in tropical and subtropical regions. The World Health Organization (WHO) reports thousands of malaria cases annually, highlighting the need for effective treatments like primaquine[2][5].

Geographical Segmentation

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America. The Asia-Pacific region, where malaria prevalence is high, drives a significant portion of the demand for primaquine. North America and Europe also show considerable demand due to advanced healthcare infrastructure and stringent public health policies. In the Middle East and Africa, public health interventions and economic considerations influence the market dynamics[2][5].

Key Players

Major players in the primaquine market include Cyper Pharma, Santa Cruz Biotechnology, Pfizer, Summit Medical Group, Novartis AG, F. Hoffmann-La Roche Ltd, Sanofi, GlaxoSmithKline plc, Cipla Inc., and Ipca Laboratories Ltd. These companies play a crucial role in the production, distribution, and research and development of primaquine phosphate[5].

Market Projections

Increasing Demand

The demand for primaquine phosphate is expected to rise due to several factors, including the increasing incidence of malaria, growing resistance to conventional treatments, and government and NGO funding for malaria eradication efforts. The push for vaccination and drug development further boosts the demand for primaquine as part of comprehensive malaria management strategies[5].

Market Dynamics

The market dynamics are influenced by a combination of drivers, restraints, opportunities, and challenges. Drivers include the rising incidence of malaria, government initiatives, and funding from organizations like the Bill & Melinda Gates Foundation. Restraints may include side effects associated with primaquine, especially in G6PD-deficient individuals, and challenges in accessing remote areas where malaria is prevalent[2][5].

Future Trends

The future of the primaquine phosphate market looks promising, with a focus on shorter, safer treatment regimens. The 7-day high-dose primaquine regimen, as shown in the IMPROV trial, is likely to become a standard practice, improving adherence and reducing the burden of P. vivax malaria. Additionally, ongoing research into adaptive dosing strategies for G6PD-deficient patients will help in developing more personalized and safer treatment plans[1][3].

Key Takeaways

• Clinical Trials: Recent studies have shown the efficacy of a 7-day high-dose primaquine regimen and the need for adaptive dosing strategies in G6PD-deficient patients.
• Market Growth: The primaquine phosphate API market is projected to grow significantly from 2023 to 2031, driven by increasing malaria incidence and government initiatives.
• Geographical Segmentation: The Asia-Pacific region is a key market due to high malaria prevalence, while North America and Europe also show significant demand.
• Key Players: Major pharmaceutical companies are involved in the production and distribution of primaquine phosphate.
• Future Trends: Shorter treatment regimens and personalized dosing strategies are expected to shape the future of primaquine use.

FAQs

What is the current standard treatment for P. vivax malaria?

The current standard treatment involves antimalarial drugs to clear parasites from the blood followed by a 14-day course of primaquine to eliminate liver hypnozoites[3].

Why is adherence to the 14-day primaquine regimen poor?

Patients often fail to complete the treatment once they feel better, leading to poor adherence to the 14-day regimen[3].

What is the significance of the 7-day high-dose primaquine regimen?

The 7-day regimen has been shown to be as effective as the 14-day treatment in preventing relapses of P. vivax malaria and is better tolerated, improving adherence[3].

How does G6PD deficiency affect primaquine treatment?

G6PD deficiency increases the risk of haemolysis with primaquine use. Recent studies are focusing on adaptive dosing strategies to minimize this risk[1].

What are the key drivers of the primaquine phosphate market?

The key drivers include the increasing incidence of malaria, government initiatives, and funding from organizations like the Bill & Melinda Gates Foundation[5].

References

1. eLife: "Primaquine in glucose-6-phosphate dehydrogenase deficiency" - February 6, 2024.
2. Market Research Intellect: "Primaquine Phosphate API Market Size, Scope And Forecast Report" - December 2024.
3. Tropical Medicine Research Unit: "New study shows faster way to cure vivax malaria" - October 15, 2024.
4. PubMed: "Primaquine for uncomplicated Plasmodium vivax malaria in children" - 2024.
5. Verified Market Research: "Primaquine Market Size, Scope, Growth, Trends and Forecast" - 2024.