Clinical Trials

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and pharmaceutical entities, trial statuses across the registry range from completed investigations to terminated and withdrawn studies.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NCT04338906 WITHDRAWN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)

Check the Camostat Mesilate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Camostat Mesilate acts as a trypsin-like protease inhibitor that potently blocks airway epithelial sodium channel (ENaC) activity with an IC50 of 50 nM, preventing essential proteolytic cleavage of host cell-surface targets. This inhibition disrupts downstream viral membrane fusion and cellular entry pathways, providing a mechanistic basis for its clinical investigation in treating SARS-CoV-2 and COVID-19 infections.

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>).

Note: Technical data last updated: Sep 1, 2026.