Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia

The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.

Start Date01 Jun 2024

Sponsor / Collaborator

R-Evolution Worldwide S.r.l.

[+5]

PACTR202402599048090

/ RecruitingPhase 2IIT

Efficacy and safety of pyronaridine/artesunate and pyronaridine/artesunate/praziquantel for treatment of uncomplicated Schistosoma haematobium infection in Gabonese adolescents and children

Start Date01 Sep 2023

Sponsor / Collaborator-

100 Clinical Results associated with Praziquantel

100 Translational Medicine associated with Praziquantel

100 Patents (Medical) associated with Praziquantel

5,953

Literatures (Medical) associated with Praziquantel

01 Apr 2025·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Safety and efficacy of praziquantel in pregnant women infected with Schistosoma haematobium

Letter

Author: Mischlinger, Johannes ; Holtfreter, Martha ; Schleenvoigt, Benjamin T ; Amoako, Yaw Ampem ; Bohnes, Tina ; Okwu, Dearie Glory

01 Feb 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Benzimidazole analogues active against adult Schistosoma mansoni: SAR analyses, In vivo efficacy in mice, and preliminary mechanistic studies as potential inhibitors of hemozoin formation

Article

Author: Attram, Henrietta Dede ; Dziwornu, Godwin A ; Masike, Keabetswe ; Haeberli, Cécile ; Njoroge, Mathew ; Keiser, Jennifer

For over three decades, praziquantel (PZQ) has been the mainstay chemotherapy for prevention and treatment of schistosomiasis. The excessive use of PZQ, coupled with the lack of advanced drug candidates in the current anti-schistosomiasis drug development pipeline, emphasizes the genuine need for new drugs. In the current work, we investigated the antischistosomal potential of a new series of compounds derived from the privileged benzimidazole scaffold, which exhibited low micromolar IC₅₀ potency in the range of 1.0-2.7 μM against Schistosomamansoni adult worms, in vitro. However, representative compounds showed low in vivo activity. One compound (15) reduced worm burden by 51.9 %, although the reduction was not statistically significant. Furthermore, by invoking inhibition of hemozoin formation, an immutable drug target in Schistosoma adult worms, as a likely contributing mode of action, we observed that the most potent analogues were equally potent inhibitors of β-hematin (synthetic hemozoin) formation in a cell-free assay.

01 Feb 2025·BIOMEDICAL CHROMATOGRAPHY

LC‐MS/MS Analyzing Praziquantel and 4‐Hydroxypraziquantel Enantiomers in Black Goat Plasma and Mechanism of Stereoselective Pharmacokinetics

Article

Author: Li, Xiarong ; Zheng, Xiantong ; Liu, Rong ; Du, Xiaoxi ; Saleh, Basma ; Shu, Xiaogui ; He, Limin

ABSTRACT:

Praziquantel (PZQ) is the most effective treatment for schistosomiasis, commonly administered as a racemic mixture of the two enantiomers. Despite many reports on the pharmacokinetics of PZQ, the stereoselective pharmacokinetics of PZQ and its major metabolite 4‐hydroxypraziquantel (4‐OH‐PZQ) remain poorly understood in goats. In this study, the chiral LC‐MS/MS method was further optimized for separating and quantifying PZQ, trans‐4‐OH‐PZQ, and cis‐4‐OH‐PZQ and their enantiomers and then applied for the molecular pharmacokinetics of three analytes in black goat plasma. The findings showed that PZQ was rapidly absorbed and metabolized to 4‐OH‐PZQ. The Cmax of trans‐4‐OH‐PZQ was about 3 times and 6 times higher than those of cis‐4‐OH‐PZQ and PZQ, respectively. The stereoselectivity of the PZQ and cis‐4‐OH‐PZQ enantiomers was insignificant in black goat plasma (p > 0.05), whereas the trans‐4‐OH‐PZQ enantiomers exhibited obvious stereoselectivity (p < 0.05). The Cmax of S‐trans‐4‐OH‐PZQ were ~3.1 times higher than that of R‐trans‐4‐OH‐PZQ. Further computer simulations indicated that these differences in the stereoselectivity might mainly stem from the different binding energies of the corresponding R‐ and S‐enantiomers of the target analytes to black goat plasma albumin. It has guiding significance for the research on the stereoselectivity of chiral veterinary drugs and their precision medication.

News (Medical) associated with Praziquantel

05 Jun 2024

·www.sciencedaily.com

Universal bitter blocker could help patients take their medicines as prescribed

Strong bitterness is the main reason why people all over the world, especially children, avoid taking their medicines, putting their health, and sometimes, their lives at risk. Now, a group of scientists has identified the first temporary, universal taste blocker that works in people. Many people, especially children and the elderly, have difficulty swallowing pills. Liquid forms of many medicines taste extremely bitter and are often rejected. Put simply, strong bitterness is the main reason why people all over the world, especially children, avoid taking their medicines, putting their health, and sometimes, their lives at risk. Now, a group of scientists at the Monell Chemical Senses Center identified the first temporary, universal taste blocker that works in people. Their findings appear in the British Journal of Pharmacology. "Remarkably, and unlike our experience with blockers of bitter taste receptors, the taste-nerve blocker we tested worked for every subject and every bitter compound we tested," said first author Linda J. Flammer, PhD, Monell Senior Research Associate and Director of the Corporate Partners Program. "I have never seen this before." Until now, efforts to block bitterness in foods and medicines have focused on finding blockers for bitter taste receptors on the tongue. Because different medications activate distinct sets of bitter taste receptors, targeting specific receptors may only suppress bitterness for certain, but not all, bitter-tasting compounds. "There is a clear need to develop bitter blockers that are able to suppress the bitterness of many medications," said co-author Carol Christensen, PhD, Monell Alumnus Faculty Member. "Although humans have 25 different bitter receptors, our ongoing research suggests only a handful of bitter receptors may be responsible for most of the bitterness of medicines." Taste cells in the mouth that express the TAS2R family of taste receptors are stimulated by sweet, bitter, and savory compounds, and transmit signals to nerve fibers by releasing adenosine triphosphate (ATP), a cell's main source of energy. In turn, ATP activates a receptor called P2X2/P2X3 on the receiving nerve cells. These nerves send information to the brain about the taste of foods and medications. The team used an inhibitor of P2X2/P2X3 receptors, called AF-353, to block taste-nerve transmission and reduce the bitterness signal caused by medications and other taste compounds. Several blockers of P2X2/P2X3 receptors have been identified, with some tested in clinical trials to treat chronic cough; however, a side effect in these trials was taste disturbance. The Monell team capitalized on the "side effect" of these compounds to create an oral treatment that enhances the palatability of medicines. A key finding of the study is that rinsing the mouth with AF-353 significantly reduced the bitterness of two important medicines that treat common chronic diseases: Praziquantel for parasites and Tenofovir Alafenamide (TAF) for hepatitis B and HIV. "AF-353 is the first universal bitter taste blocker that has been identified," said Monell Faculty Member Peihua Jiang, PhD. "In addition to bitter taste, it also affects savory, salt, sweet, and sour tastes. However, AF-353 only blocks taste. Other oral sensations like the tingle from carbonation were not affected." The team conducted both human sensory taste testing and mouse behavioral experiments to determine the breadth, strength, and duration of the blocking effects. The results of the human and rodent studies were similar in the breadth and duration of AF-353's action. The topical application of AF-353 directly into the mouth may improve compliance of many important medications, especially those that are life-saving for children in developing countries. "In people, the blocking effect lasted 60 to 90 minutes, when their taste was restored to normal," said Flammer. "We are now looking for taste blockers that act faster and allow taste to return to normal sooner," said Jiang.orted by the Bill & Melinda Gates Foundation (INV-037008 and INV-042630). The behavioral work was performed at the Monell Behavioral and Physiological Phenotyping Core, which is supported, in part, by the National Institutes of Health (NIH) NIDCD Core Grant 1P30DC011735-01. Research infrastructure was provided in part by NIH Grant G20OD020296.

Clinical Result

02 Apr 2024

·www.fiercepharma.com

Merck KGaA names winner of storytelling competition to boost schistosomiasis awareness in Ethiopia

In addition to supplying praziquantel, Merck KGaA’s four-pronged efforts toward “#MakingSchistoHistory” comprise developing new treatments for the disease, implementing health education and water safety initiatives and forming partnerships to bolster all of that work. After nearly two decades spent working with the World Health Organization (WHO) to supply billions of praziquantel tablets to help treat schistosomiasis, Merck KGaA has recently tacked on an additional awareness-raising component to its efforts to eliminate the parasitic disease also known as bilharzia. That project has been dubbed the Bilharzia Storytelling Lab, and it wrapped up its third iteration late last month, the drugmaker announced Tuesday. The latest lab took place in Ethiopia, following previous installments in Kenya and Rwanda. For this year’s lab, local participants were invited to a five-day workshop in Addis Ababa, during which they learned more about schistosomiasis and received instruction on storytelling from local and international experts. From there, the participants worked with health-focused and other nonprofit organizations to develop storytelling-based solutions that could help raise awareness about the disease in their communities. A panel of judges was tasked with selecting the best solution, which Merck will help implement throughout Ethiopia. The winning solution this year—which was awarded a grand prize of 10,000 euros—uses multimedia participatory theater to improve awareness of schistosomiasis, specifically targeting young men working in sugar factories. “We have seen great pitches today and it wasn’t easy to pick only one. In the end, we decided on Team Buna because it is an innovative and locally applicable solution, which is also scalable to surrounding communities,” Johannes Waltz, head of the Merck Schistosomiasis Elimination Program, said in a statement after judging was complete. The previous two winners included a card game that could educate young children about the disease through play and a school notebook that included information about disease prevention for both children and their caregivers, according to Merck. Schistosomiasis infections occur when the skin is exposed to parasites in bodies of water. After infection, parasite eggs that aren’t passed out of the body may become trapped within tissues, resulting in immune reactions and organ damage, per a WHO fact sheet. The organization has placed schistosomiasis in its group of neglected tropical diseases, as it is especially prevalent in poor communities within tropical and subtropical regions that don’t have ready access to clean water. The WHO estimates that at least 90% of the approximately 250 million people requiring treatment for the disease live in Africa. Since 2007, Merck KGaA has been working with the WHO to distribute praziquantel tablets, the recommended treatment for the disease, with efforts focused mainly on sub-Saharan Africa. Merck said in this week’s announcement that it provides the organization with up to 250 million tablets per year, for a total donation to date of 2 billion tablets, which have been used to treat around 800 million people. In addition to supplying praziquantel, Merck’s four-pronged efforts toward “#MakingSchistoHistory” comprise developing new treatments for the disease, implementing health education and water safety initiatives and forming partnerships to bolster all of that work.

17 Dec 2023

·www.prnewswire.com

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

- Astellas contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium - TOKYO, Dec. 17, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged children (3 months to 6 years of age) on December 15. EMA assessed arpraziquantel under the EU-Medicines for all (EU-M4all) *1 procedure for high-priority medicines intended for use in countries outside the European Union. For more details on arpraziquantel, please refer to the Consortium's press release. Continue Reading Astellas provided its innovative formulation technology to co-develop arpraziquantel as a member of the Consortium. The new pediatric formulation of arpraziquantel is palatable for very young children by reducing the bitter taste associated with the medication and administered via a 150 mg dispersible tablet that is dissolved in water. The prototype of the pediatric formulation has been developed by Astellas and further optimized by Merck (Germany) for global production using simple manufacturing processes yielding tablets that can remain shelf stable, even in hot and humid tropical climates. Farmanguinhos (Brazil) brings expertise in production and distribution and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. The partnership with Universal Corporation Ltd. (Kenya) is also supporting the planned future large-scale local production to serve African countries. In parallel with this regulatory work, the Consortium's implementation research program (ADOPT)*2 is ongoing and preparing for the introduction of arpraziquantel in the first endemic countries in Africa. To ensure equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available at an at-cost basis in sub-Saharan African countries. Astellas has set a Strategic Goal to "deepen our engagement in sustainability" in the Astellas Corporate Strategic Plan 2021. To address the key sustainability issue of Access to Health (ATH), Astellas uses a comprehensive approach including, (1) Astellas' core business (Rx, Rx+), (2) Enhancing availability of Astellas products (Access to Medicines), and (3) Collaboration and support for the activities implemented by external partners. Initiatives in the Consortium apply to (3), and the positive CHMP scientific opinion by EMA of arpraziquantel represents a significant milestone in alignment with Astellas' Access to Health focus. Naoki Okamura, President and CEO, Astellas "We are so pleased that arpraziquantel received a positive scientific opinion by EMA, and also proud that Astellas could contribute to its development by providing our innovative formulation technologies. Access to Health is essential to the health of people around the world, and we recognize it as a material issue for Astellas. Through our VISION to be "On the forefront of healthcare change to turn innovative science into VALUE for patients", we are proactively taking a comprehensive approach to solving this issue." For more information on Astellas' contribution to the development of arpraziquantel, please see (). About schistosomiasis Schistosomiasis (also known as bilharzia) is one of the most prevalent parasitic diseases worldwide and a very important one in terms of public health burden and economic impact. It is a poverty-related disease that is widespread in tropical and subtropical regions where large sections of the population have no access to clean water. Flatworms transmit the disease and people become infected with the parasite through contact with freshwater, for example, while working, swimming, fishing, or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels, and attack internal organs. The infection rate is particularly high among children. Schistosomiasis is a chronic condition and is classified by the World Health Organization (WHO) as one of 20 neglected tropical diseases (NTDs). About Arpraziquantel The current standard of care treatment for schistosomiasis is praziquantel. Praziquantel is safe, effective, and suitable for school-aged children and adults. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for preschool-aged children against Schistosoma mansoni and Schistosoma haematobium. Tested in clinical development, under the responsibility of Merck, arpraziquantel contains the pharmacologically active enantiomer of praziquantel. In developing arpraziquantel, the Pediatric Praziquantel Consortium established a pediatric drug development program, divided into four major steps: preclinical development, clinical development, registration, and access. All details can be found on the Consortium website. About the Pediatric Praziquantel Consortium The Pediatric Praziquantel Consortium is an international public-private partnership that aims to reduce the global disease burden of schistosomiasis and improve child health by addressing the medical needs of infected preschool-aged children. Its mission is to develop, register, and provide access to a suitable pediatric drug for treating schistosomiasis in children 3 months to 6 years of age. For more information, and to see an overview of all Consortium partners, visit the Consortium website. Consortium Partners Merck (Germany) Astellas Pharma Inc. (Japan) The Swiss Tropical and Public Health Institute (Switzerland) Lygature (The Netherlands) Farmanguinhos (Brazil) Unlimit Health (United Kingdom) Kenya Medical Research Institute (Kenya) Université Félix Houphouët-Boigny (Côte d'Ivoire) Klinikum rechts der Isar der Technischen Universität München (Germany) Ministry of Health Côte d'Ivoire (Côte d'Ivoire) African Institute for Health and Development (Kenya) Other collaborators that contribute to the mission of the Pediatric Praziquantel Consortium: Makerere University School of Public Health (Uganda) Ministry of Health Kenya, Division of Vector Borne and NTDs (Kenya) Ministry of Health Uganda, Vector Borne and NTDs Control Division (Uganda) About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. SOURCE Astellas Pharma Inc.

Drug Approval

100 Deals associated with Praziquantel

External Link

KEGG	Wiki	ATC	Drug Bank
D00471	Praziquantel	P02BA01	DB01058

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Clonorchiasis	JP	Bayer Yakuhin Ltd.	20 Sep 1988
Paragonimiasis	JP	Bayer Yakuhin Ltd.	20 Sep 1988
Helminthiasis	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1985
Trematode Infections	US	Bayer HealthCare Pharmaceuticals, Inc.	29 Dec 1982

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Female genital tract infection	Phase 3	MG	Merck Serono International SA	03 Sep 2019
Schistosomiasis	Phase 3	MG	Merck Serono International SA	03 Sep 2019
Schistosomiasis Haematobia	Phase 3	EG	Pharco Pharmaceuticals, Inc.	01 Dec 2011
Schistosomiasis Mansoni	Phase 3	EG	Pharco Pharmaceuticals, Inc.	01 Dec 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03845140 (CTgov)	Phase 3	Schistosomiasis Mansoni	288	L-PZQ ODT 50 mg/kg (Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg)	oydrgpfzef(cphmdznhga) = qpulhyfwns yaiyhqokoi (yltmzaoong, cspiwofgkh - hrcjphajaf) View more	-	21 Mar 2024
				Biltricide® (Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg)	oydrgpfzef(cphmdznhga) = btjtmtzvgg yaiyhqokoi (yltmzaoong, iddhgkmqvj - dgyenrdsmk) View more
NCT03893097 (SchistoSAM, Pubmed \| Nat Med) Manual	Phase 3	Schistosomiasis	718	Praziquantel	wwtvacmxmk(daoeindcdw) = rzywrnqzmm ymtjnhcyut (lhdzrzumao ) View more	Non-inferior	01 Jan 2024
				Artesunate-mefloquine	wwtvacmxmk(daoeindcdw) = rzohvazbab ymtjnhcyut (lhdzrzumao ) View more
NCT04635553 (Pubmed \| BMC Infect Dis)	Not Applicable	Schistosomiasis Haematobia	777	praziquantel (Children from Mbane village)	sqqturizib(ypsofjiuzg) = dpzathidvl feqbinzuqt (nxipserhff ) View more	-	29 Dec 2022
				praziquantel (Children from Dioundou and Khodit villages)	sqqturizib(ypsofjiuzg) = hsuwpglhik feqbinzuqt (nxipserhff ) View more
NCT02868385 (RePST trial \| RePST, Pubmed \| PLoS Negl Trop Dis)	Phase 3	Schistosomiasis Mansoni	167	praziquantel (Standard treatment group)	soaqvviywj(nrayzvluvy) = coixtoqwvz gafcipaibp (wnxylpjzve, 32 - 59)	-	22 Dec 2022
				praziquantel (Intense treatment group)	soaqvviywj(nrayzvluvy) = batsqwnnkq gafcipaibp (wnxylpjzve, 66 - 87)
NCT03845140 (PipelineReview) Manual	Phase 3	Schistosomiasis	-	Praziquantel	iidwtepart(vuuswplauv) = High efficacy was observed with cure rates close to or above 90% for S. mansoni (at a dose of 50 mg/kg) and S. haematobium (at a dose of 60 mg/kg). thjocgcmjf (gywxryrsbb ) View more	Positive	16 Nov 2021
NCT04314037 (CTgov)	Phase 1	-	36	Cesol (Cesol First Administration)	hyjhmtftkz(cywuupswjh) = ooneirnlev apemoyyeqv (hrprijdgqa, btqgznwxme - vgzstqdypx) View more	-	13 Aug 2021
				Cesol (Cesol Second Administration)	hyjhmtftkz(cywuupswjh) = iwylkvguyj apemoyyeqv (hrprijdgqa, svkpdsmqzf - szalumbbff) View more
NCT02868385 (RePST, Pubmed \| PLoS Negl Trop Dis)	Phase 3	Schistosomiasis Mansoni	-	Single dose of PZQ	ephmynexzs(etyggheduq) = dzouwritwl zrduukacnp (gdtbgeplhb, 31 - 52) View more	-	20 Mar 2020
				Four repeated doses of PZQ	ephmynexzs(etyggheduq) = zcozjkmwkz zrduukacnp (gdtbgeplhb, 75 - 92) View more
NCT02806232 (CTgov)	Phase 2	Schistosomiasis Mansoni	444	Biltricide (racemate praziquantel) oral tablets (Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg)	pojjyvpzgv(pocqsmoifq) = vukhlefpun crimjpevya (pzyznbtief, dndptiktpa - ojamceegms) View more	-	20 Nov 2019
				Biltricide (racemate praziquantel) oral tablets (Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg)	pojjyvpzgv(pocqsmoifq) = rvrnsdbjsq crimjpevya (pzyznbtief, rmcwrhcikp - mvohucxljk) View more
ISRCTN15280205 (Pubmed \| Lancet Glob Health)	Phase 2	Schistosomiasis Mansoni	-	20 mg/kg praziquantel	kegqydrnlo(rgbdtzxsvs) = ckryrkmqqg gqpjbcedte (skyqypuylb, 44.8 - 77.5)	-	01 Jul 2017
				40 mg/kg praziquantel	kegqydrnlo(rgbdtzxsvs) = nexvertxge gqpjbcedte (skyqypuylb, 54.8 - 85.8)

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