Cycloheximide Clinical Trials

Size	Price	Qty
200mg	USD 147
500mg	USD 247

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate this compound dataset across diverse therapeutic and diagnostic applications. These studies investigate dental and oral conditions—including dental caries, apical periodontitis, and periodontal disease—alongside diagnostic PET imaging in solid malignancies like mesothelioma, pancreatic, ovarian, and non-small cell lung cancers. Supported by academic and corporate sponsors including the University of Southern California and Morphotek, recruitment statuses encompass active recruiting, completed, not yet recruiting, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03700788	Not yet recruiting	Apical Periodontitis	University of Southern California	2023-05-30	Phase 3
NCT05506566	Recruiting	Tumor\|Positron-Emission Tomography	First Affiliated Hospital of Fujian Medical University	2022-05-01	Phase 1\|Phase 2
NCT02202304	Withdrawn	Periodontal Disease\|Caries	Rosa Moreno Lopez\|Ivoclar Vivadent AG\|University of Aberdeen	2017-09-10	Phase 4
NCT01521325	Completed	Mesothelioma\|Pancreatic Cancer\|Ovarian Cancer\|Non-small Cell Lung Cancer	Morphotek	2011-09	Phase 1
NCT02168374	Completed	Dental Caries	Aline R F de Castilho\|Fundação de Amparo à Pesquisa do Estado de São Paulo\|University of Campinas Brazil	2008-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cycloheximide specifically binds to the 80S ribosome of eukaryotic cells to block translational elongation, thereby halting protein biosynthesis and inhibiting downstream cellular protein production. This disruption of global protein translation leads to cellular growth arrest and cytotoxicity, providing a rationale for evaluating tumor dynamics in clinical conditions such as mesothelioma, pancreatic cancer, ovarian cancer, and non-small cell lung cancer.

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>).