Several clinical trials evaluate praziquantel across therapeutic and pharmacokinetic applications, targeting schistosomiasis, opisthorchiasis, and liver fluke-related cholangiocarcinoma, alongside behavioral interventions and bioequivalence in healthy volunteers and endemic populations. Spanning Phase 1 and non-applicable trial phases, these studies—with recruitment statuses listed as completed, not yet recruiting, or unknown—are funded by academic, government, and industry sponsors, including Khon Kaen University, the National Institute of Allergy and Infectious Diseases, and Merck KGaA.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05321992 | Not yet recruiting | Cholangiocarcinoma|Liver Fluke-Related Cholangiocarcinoma|Opisthorchiasis |
McMaster University|Khon Kaen University|Global Alliance for Chronic Diseases (GACD)|Canadian Institutes of Health Research (CIHR) |
2024-07-01 | Not Applicable |
| NCT04635553 | Unknown status | Schistosomiasis |
Institut de Recherche pour le Developpement |
2020-08-11 | -- |
| NCT04314037 | Completed | Healthy |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany |
2020-06-17 | Phase 1 |
| NCT03870204 | Completed | Aged ≥2 Years in Schistosomiasis Affected Areas |
Ina-Respond|National Institute of Health Research and Development Ministry of Health Republic of Indonesia|The National Institute of Allergy and Infectious Diseases United States |
2019-09-04 | -- |
| NCT03437447 | Completed | Healthy |
Merck KGaA Darmstadt Germany |
2018-06-18 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).