SBE-β-CD Clinical Trials

Size	Price	Qty
1g	USD 197
5g	USD 497

Clinical Trials

Several clinical trials evaluate formulations containing SBE-β-CD across Phase I and Phase II studies, addressing conditions such as multiple myeloma, light chain amyloidosis, type II diabetes mellitus, post-operative nausea and vomiting, contrast-induced nephropathy, and pharmacokinetic profiles in healthy volunteers. Sponsored by academic centers and pharmaceutical entities, these trials encompass active, completed, and withdrawn recruitment statuses. Overall, these clinical evaluations highlight the widespread utility of SBE-β-CD as a solubilizing excipient in targeted drug delivery systems.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02909036	ACTIVE_NOT_RECRUITING	Multiple Myeloma; Amyloidosis	Memorial Sloan Kettering Cancer Center	2016-09	PHASE1
NCT04627831	WITHDRAWN	Contrast-induced Nephropathy	Ligand Pharmaceuticals	2022-01	PHASE2
NCT03869983	COMPLETED	Contrast-induced Nephropathy; Coronary Angiography	CyDex Pharmaceuticals, Inc.	2019-04-12
NCT02723201	COMPLETED	Healthy	Takeda	2016-04-28	PHASE1
NCT02250222	COMPLETED	Type 2 Diabetes Mellitus	Ligand Pharmaceuticals	2014-10	PHASE1
NCT01919684	COMPLETED	Type 2 Diabetes Mellitus	Ligand Pharmaceuticals	2013-11	PHASE1
NCT01290133	COMPLETED	Post-Operative Nausea and Vomiting (PONV)	Accenture	2011-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-10-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

SBE-β-CD non-covalently encapsulates hydrophobic drug molecules within its lipophilic central cavity, increasing aqueous solubility and preventing chemical degradation without altering the active agent's primary pharmacodynamics. By enhancing systemic bioavailability and dissolution kinetics, this modified cyclodextrin facilitates optimal therapeutic delivery in clinical applications including multiple myeloma, light chain amyloidosis, and contrast-induced nephropathy.

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>).