Praziquantel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BILTRICIDE | — | 1982-12-29 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03640377 Comparator | Feb 2021 → Feb 2024 | Schistosoma japonicum infectious disease, Schistosoma mansoni infectious disease | Rhode Island Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01901484 Comparator | Dec 2012 → Feb 2014 | intestinal schistosomiasis | Makerere University | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06565507 Comparator | Dec 2026 → Mar 2030 expected | cysticercosis | Universidad Peruana Cayetano Heredia | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT04679831 Comparator | May 2021 → Mar 2022 | Schistosoma mansoni infectious disease | Kenya Medical Research Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT00441285 Comparator | Jan 2010 → Dec 2012 | cysticercosis, epilepsy | Universidad Peruana Cayetano Heredia | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03893097 Comparator | Oct 2019 → Mar 2021 | Schistosoma mansoni infectious disease | Institute of Tropical Medicine, Belgium | Completed | No outcome recorded |
| Phase 3 | NCT03845140 Comparator | Sep 2019 → Oct 2021 | schistosomiasis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 3 | NCT01722539 Background | Nov 2012 → Nov 2013 | — | University of Antwerp | Completed | No outcome recorded |
| Phase 3 | NCT01054651 Comparator | Oct → Dec 2009 | Schistosoma mansoni infectious disease | Kenya Medical Research Institute | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07074444 Comparator | Jul 2025 → Nov 2026 expected | clonorchiasis | First Affiliated Hospital of Guangxi Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT01459146 Comparator | Dec 2010 → Oct 2011 | anemia, malaria, schistosomiasis | Navrongo Health Research Centre, Ghana | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07707817 Background | Jul 2026 → Jul 2027 expected | intestinal helminthiasis, onchocerciasis, schistosomiasis | Uwemedimo Friday Ekpo | Recruiting | No outcome recorded |
| — | NCT05323396 Comparator | May 2022 → Aug 2023 | coinfection | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT02144389 Comparator | Jan → Jul 2013 | Schistosoma mansoni infectious disease | dsm-firmenich Switzerland AG | Completed | No outcome recorded |
| — | NCT00817713 Comparator | Jan 2009 → Sep 2010 | HIV infectious disease, helminthiasis | Swiss Tropical & Public Health Institute | Terminated | No outcome recorded |
| — | NCT01050374 Comparator | Oct 2007 → Oct 2008 | parasitic infectious disease | DBL -Institute for Health Research and Development | Completed | No outcome recorded |
| — | NCT01050517 Comparator | Oct → Dec 2007 | parasitic infectious disease | DBL -Institute for Health Research and Development | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Praziquantel | “A randomized controlled trial was used to compare the effectiveness of praziquantel in treating Schistosoma haematobium in Africa using two different sources for the drug,...” PMID 30969960 ↗ Apr 201945“The intervention drugs are standard drugs approved by the World Health Organisation for the preventive treatment of malaria (sulphadoxine-pyrimethamine and amodiaquine),...” NCT06182176 ↗ “Re-assessment by questionnaire, physical examination and sampling for STIs was undertaken 4 weeks later followed by systematic praziquantel treatment to general community,...” NCT00713999 ↗ “Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after...” NCT03845140 ↗ “Praziquantel (PZQ) is currently the only recommended drug for infection and disease caused by the schistosome species that infects humans” PMID 34106922 ↗ Jun 2021 “Relative Bioavailability of Orally Dispersible Tablet Formulations of Levo- and Racemic Praziquantel: Two Phase I Studies.” PMID 30536632 ↗ Dec 2018 “Praziquantel single dose 40mg/kg will be given for infection with Schistosoma mansoni and Schistosoma haematobium.” NCT05323396 ↗ “Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole” NCT02366884 ↗ “or 40mg/Kg body weight of Praziquantel as a single oral dose.” NCT01529710 ↗ |
| Known as | Biltricide | “Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after...” NCT03845140 ↗1“Biltricide (racemate praziquantel) oral tablets” NCT02806232 ↗ |
| Known as | Cesol | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Cestocur | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Cisticid | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Cysticide | “Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods.” NCT02271984 ↗ |
| Known as | Distocide | “one received a single standard dose of praziquantel (Distocide® 600 mg, Shin Poong Pharmaceuticals, Seoul, Republic of Korea), 40mg/kg body weight, while the other group...” PMID 23596262 ↗ Apr 20131“Praziquantel (Distocide) 60 mg/kg single oral dose” NCT00403611 ↗ |
| Known as | EMBAY 8440 | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | NSC-757285 | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Prazicuantel | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Praziquantel component of broadline | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Praziquantel component of profender | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | Praziquantelum | ChEMBL registry synonym — accepted as the source's own label CHEMBL976 ↗ |
| Known as | PZQ | “A longitudinal study was conducted to evaluate the impact of praziquantel (PZQ) for the treatment of Schistosoma mansoni infection among schoolchildren in Al Gunaid in Central Sudan.” PMID 21729382 ↗ Jun 20119“The study was conducted in Djalakorodji, a peri-urban area of Bamako, Mali, using a double blind setup in which As+SMP was compared with praziquantel (PZQ).” PMID 19802383 ↗ Oct 2009 “Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.” NCT02806232 ↗ “The exclusive use of praziquantel (PZQ) in mass drug administration programmes may result in the emergence of drug resistance.” PMID 34168029 ↗ Jun 2021 “The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby” NCT00486863 ↗ “Praziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours.” NCT01288872 ↗ “Preventive chemotherapy with praziquantel (PZQ) is the cornerstone of schistosomiasis control.” PMID 32196506 ↗ Mar 2020 “Praziquantel (PZQ), the drug used worldwide for the treatment of schistosomiasis” NCT03640377 ↗ “Praziquantel (PZQ) is a drug used to treat this infection.” NCT02734186 ↗ “Drug: Praziquantel (PZQ)” NCT02144389 ↗ |
| Known as | Racemate Praziquantel | “Biltricide (racemate praziquantel) oral tablets” NCT02806232 ↗ |
| Modality | Small molecule | “Praziquantel is a heterocyclic prazino-isoquinoline derivative with significant activity against both cestodes and trematodes.” NCT00507221 ↗ |
| Route | Oral | “single oral dose” NCT00403611 ↗ |