β-Cyclodextrin Clinical Trials

Size	Price	Qty
500mg	USD 97
1g	USD 129

Clinical Trials

Multiple completed clinical trials have evaluated therapeutic formulations containing beta-cyclodextrin derivatives, including antiviral agents and intravenous hydroxypropyl-beta-cyclodextrin. Spanning Phase 1/2 and Phase 2/3 studies, these evaluations were conducted by industry sponsors, including Gilead Sciences and Cyclo Therapeutics Inc., to assess safety, tolerability, pharmacokinetics, and efficacy in treating COVID-19 and Niemann-Pick Disease Type C1.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04431453	Completed	COVID-19	Gilead Sciences	2020-07-21	Phase 2\|Phase 3
NCT02912793	Completed	Niemann-Pick Disease Type C1	Cyclo Therapeutics Inc.	2017-03-20	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Beta-cyclodextrin forms dynamic host-guest inclusion complexes by encapsulating hydrophobic molecules within its lipophilic central cavity, thereby dramatically enhancing aqueous solubility, chemical stability, and membrane permeability. By facilitating effective lipid solubilization and cholesterol transport, this functional host-guest interaction reduces intracellular lysosomal cholesterol accumulation in Niemann-Pick Disease Type C1 and enhances drug delivery efficacy in therapeutic formulations for COVID-19.

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>).