Multiple clinical trials evaluate Camostat Mesilate as both monotherapy and combination regimens across Phase 1, Phase 2, and Phase 4 development. These studies primarily target COVID-19, SARS-CoV-2 infection, and severe acute respiratory syndrome, alongside associated conditions including diabetes, hypertension, and obesity. Sponsored by academic institutions, comprehensive cancer centers, and pharmaceutical entities, trial statuses across the registry range from completed investigations to terminated and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04321096 | COMPLETED | Corona Virus Infection |
University of Aarhus |
2020-04-04 | PHASE1; PHASE2 |
| NCT04470544 | COMPLETED | Severe Acute Respiratory Syndrome |
Alan Bryce |
2020-07-28 | PHASE2 |
| NCT04338906 | WITHDRAWN | COVID |
Heinrich-Heine University, Duesseldorf |
2020-05 | PHASE4 |
| NCT04681430 | COMPLETED | Corona Virus Infection; SARS-CoV-2 Infection; SARS-CoV-2 PCR Test Positive; SARS-CoV-2 Acute Respiratory Disease |
Heinrich-Heine University, Duesseldorf |
2021-01-08 | PHASE2 |
| NCT04652765 | TERMINATED | Covid19; SARS-CoV Infection; Coronavirus Infection |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2021-02-03 | PHASE1 |
| NCT04530617 | TERMINATED | Covid19; Diabetes; Hypertension; Obesity |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2020-10-05 | PHASE2 |
| NCT04524663 | COMPLETED | Covid19 |
Stanford University |
2020-12-19 | PHASE2 |
| NCT04583592 | COMPLETED | COVID-19 |
Sagent Pharmaceuticals Inc. |
2020-11-09 | PHASE2 |
| NCT04353284 | COMPLETED | COVID-19 |
Yale University |
2020-06-09 | PHASE2 |
| NCT04374019 | TERMINATED | COVID; Sars-CoV2 |
Susanne Arnold |
2020-05-01 | PHASE2 |
| NCT04455815 | Terminated | COVID-19 Infection |
Cancer Research UK|Latus Therapeutics |
2020-09-23 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2025-04-18)
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>).