CLINICAL TRIALS PROFILE FOR PRAZIQUANTEL

All Clinical Trials for PRAZIQUANTEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00215267 ↗	The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda	Completed	Ministry of Health, Uganda	N/A	2005-09-01	The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control. The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.
NCT00215267 ↗	The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda	Completed	DBL -Institute for Health Research and Development	N/A	2005-09-01	The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control. The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.
NCT00231322 ↗	Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique	Completed	Durban University of Technology	N/A	2004-03-01	To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)
NCT00231322 ↗	Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique	Completed	Durban University of Technology South Africa	N/A	2004-03-01	To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)
NCT00231322 ↗	Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique	Completed	DBL -Institute for Health Research and Development	N/A	2004-03-01	To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)
NCT00276224 ↗	Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia	Completed	DBL -Institute for Health Research and Development	N/A	2005-09-01	The objectives of this study is: - to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months - document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools - compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months - determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months
NCT00347113 ↗	Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania	Completed	DBL -Institute for Health Research and Development	N/A	2006-07-01	The proposed study has as the main objective to investigate the effect of schistosome and STH infections and the effect of an anthelminthic intervention on P. falciparum malaria, related anaemia and malaria antibody responses among school and pre-school children in Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be determined by examination of blood, faecal and urine samples. Spleen and liver size and consistency will be determined by palpation. P. falciparum specific antibodies will be determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg and albendazole 400mg. Children selected to participate in the intervention trial will be randomized into two groups, an intervention group of 258 children which will be followed up with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths Control Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline survey will be repeated.

Clinical Trial Conditions for PRAZIQUANTEL

Condition Name

Condition Name for PRAZIQUANTEL
Intervention	Trials
Schistosomiasis	15
Healthy	8
Malaria	5
Neurocysticercosis	5

Condition MeSH

Condition MeSH for PRAZIQUANTEL
Intervention	Trials
Schistosomiasis	26
Schistosomiasis haematobia	8
Malaria	7
Neurocysticercosis	6

Clinical Trial Locations for PRAZIQUANTEL

Trials by Country

Trials by Country for PRAZIQUANTEL
Location	Trials
Uganda	6
Tanzania	6
Germany	5
Gabon	3
Kenya	3

Trials by US State

Trials by US State for PRAZIQUANTEL
Location	Trials
Maryland	2

Clinical Trial Progress for PRAZIQUANTEL

Clinical Trial Phase

Clinical Trial Phase for PRAZIQUANTEL
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for PRAZIQUANTEL
Clinical Trial Phase	Trials
Completed	36
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for PRAZIQUANTEL

Sponsor Name

Sponsor Name for PRAZIQUANTEL
Sponsor	Trials
DBL -Institute for Health Research and Development	8
Merck KGaA, Darmstadt, Germany	6
Merck KGaA	5

Sponsor Type

Sponsor Type for PRAZIQUANTEL
Sponsor	Trials
Other	94
Industry	21
NIH	7

PRAZIQUANTEL Market Analysis and Financial Projection

Last updated: April 27, 2026

Praziquantel: Clinical Trial Landscape, Market Analysis, and 2030+ Projection

What is the current clinical-trial picture for praziquantel?

Praziquantel is an established antiparasitic used for schistosomiasis and other parasitic indications. Because the molecule is mature and widely manufactured, clinical activity is concentrated in (1) regulatory lifecycle work for formulations and pediatric dosing and (2) new combination regimens, including fixed-dose and partner-drug studies. For investment-grade decisions, the key point is that the “trial footprint” is not driven by brand-new mechanism candidates, but by regimen optimization and formulation/presentation strategy.

Trial typology seen for praziquantel (high-level):

• Dose and safety confirmation in endemic populations, including children and special populations.
• Combination therapy trials (praziquantel with other antiparasitics or new candidates) to address resistance risk, reinfection, or broader parasitic coverage.
• Formulation work (e.g., dispersible tablets, pediatric-friendly dosage forms) and pharmacokinetic bridging to improve dosing practicality and adherence.

Implication for forecasting: clinical-trial timelines do not typically gate near-term supply or revenue growth for praziquantel itself; they more often gate uptake through WHO and national program guidance, pediatric label expansions, and procurement preferences.

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How big is the praziquantel market today?

Praziquantel demand is primarily tied to public health procurement for schistosomiasis control. Commercial sales outside endemic-program channels exist, but the market is strongly influenced by:

• Mass drug administration (MDA) schedules and program funding,
• Disease prevalence (endemic geography and treatment coverage),
• Payer procurement cycles and supply contracts,
• Price pressure from generic manufacturing and tendering.

Core market drivers

• Burden of schistosomiasis drives recurring treatments.
• Treatment targets (program-level coverage goals) drive annual procurement volumes.
• Pediatric and community dosing logistics push adoption of more usable formulations.
• Generic erosion keeps pricing disciplined, making volume the main lever.

Supply-side structure

• Praziquantel is widely generic, lowering the role of exclusive IP in economics.
• The market behaves like a procurement commodity with tender-driven dynamics.

What this means for market sizing: projections should be built on treatment volume, not product differentiation. Model outcomes hinge on (1) endemic coverage growth, (2) reinfection and retreatment cycles, and (3) program funding stability.

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What do the major demand forecasts imply through 2030?

A practical projection framework for praziquantel is treatment volume rather than unit-price growth. Under this lens, the market tends to follow:

• Low-to-moderate growth from expanding coverage and new endemic program rollouts,
• Stable to mild growth from re-treatment cycles,
• Broad price stagnation from generic competition,
• Occasional step-ups when new WHO recommendations or program funding cycles expand MDA intensity.

Base-case projection logic (treatment-driven):

• If program coverage rises and population treated expands, unit demand rises even without pricing lift.
• If coverage plateaus or funding softens, volume growth compresses and pricing remains flat or declines further.
• If pediatric formulation adoption increases, it improves treatment delivery rather than changing the underlying therapeutic demand.

Market behavior to expect

• Price: constrained by generic tendering.
• Growth: tied to MDA scale and coverage improvements.
• Volatility: linked to global public health funding cycles and commodity procurement timing.

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How does IP and exclusivity affect growth expectations for praziquantel?

Praziquantel’s economics are dominated by generic availability. That affects forecasting in two ways:

1. Limited pricing power: market value growth is mostly volume-driven.
2. Long-run stability: supply is resilient because the active is mature and manufactured at scale.

Investment takeaway: growth opportunities are more likely tied to formulation differentiation for procurement compliance and pediatric accessibility, and to contract wins, than to patent-led market expansion.

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Competitive and development landscape: where value still concentrates

Even for mature drugs, value concentrates in execution and procurement access. The most relevant differentiators for praziquantel are:

• Formulation usability (pediatric-friendly dosing, dispersible or easy-to-administer presentations)
• Supply reliability (tender performance, lead times, quality systems)
• Program alignment (ability to meet MDA procurement specifications)
• Regulatory lifecycle (line extensions for labels that improve program adoption)

In practical terms, “clinical trial success” does not translate into the typical blockbuster dynamic for praziquantel. Trials more often translate into procurement eligibility and label breadth.

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Clinical trial update: what to monitor going forward

Because praziquantel is off-patent in most geographies, the most decision-relevant signals are not “new mechanism” breakthroughs, but operational and regimen signals.

Monitor for:

• Combination regimen readouts that improve efficacy in relevant parasite species or in high reinfection settings.
• Pediatric dosing and formulation bridging that improves adoption by national programs.
• Safety surveillance in repeat-treatment cohorts that affects program confidence.
• WHO guideline updates that change dosing frequency, target species, or recommended presentations.

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Market projection: scenario structure for decision-grade modeling

Build scenarios around three variables:

1. Global MDA coverage growth (rate of treated population expansion)
2. Re-treatment frequency (driven by reinfection and program protocols)
3. Procurement pricing trend (tender dynamics, generic oversupply, and currency effects)

Resulting expectation profile

• Base case: stable-to-moderate volume growth; limited pricing upside.
• Upside case: coverage acceleration plus favorable inclusion of additional indications or improved formulations in tenders.
• Downside case: slower coverage growth and funding pressure leading to procurement deferrals; price may hold due to tendering but volumes soften.

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Key Takeaways

• Praziquantel’s clinical trial activity is primarily regimen and formulation/pediatric lifecycle oriented, not mechanism-led innovation.
• Market demand is driven by recurring public health treatment for schistosomiasis, making volume and program coverage the core determinants.
• Pricing growth is structurally capped by generic competition; market value growth tracks treated population and procurement cycles.
• The most investable levers are formulation usability for procurement and supply reliability for tender performance, rather than patent-driven exclusivity.

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FAQs

1) Does praziquantel have active development that could change market dynamics?

Clinical activity is centered on lifecycle improvements (formulation/pediatric work) and combination or regimen optimization. This tends to affect procurement eligibility and uptake more than it changes pricing power.

2) What drives praziquantel demand most strongly?

Public health procurement for schistosomiasis control, including MDA coverage and retreatment schedules.

3) Is market growth dependent on patent protection?

No. The market is primarily generic and procurement-driven; pricing power is limited and value growth is mostly volume-driven.

4) What signals should investors track for forward demand?

WHO or national guideline changes that alter dosing frequency or target coverage, plus MDA funding and treatment coverage trends.

5) What is the most credible way to model praziquantel revenue?

Use a treatment-volume scenario model tied to treated population growth, retreatment cycles, and tender price trends rather than relying on unit price increases.

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References

1. World Health Organization. (2024). Schistosomiasis: Fact sheet. https://www.who.int/news-room/fact-sheets/detail/schistosomiasis
2. World Health Organization. (2024). Schistosomiasis control. https://www.who.int/teams/control-of-neglected-tropical-diseases/schistosomiasis
3. U.S. National Library of Medicine. (n.d.). Praziquantel clinical trials (search results). ClinicalTrials.gov. https://clinicaltrials.gov/