2-DI-1-ASP Clinical Trials

Size	Price	Qty
100mg	USD 97
1g	USD 370

Clinical Trials

Multiple clinical trials sponsored by Chong Kun Dang Pharmaceutical are currently evaluating regimens involving this compound for Type II Diabetes Mellitus in Phase 1 settings. Conducted in healthy volunteer populations, these studies assess pharmacokinetic properties, safety, and drug-drug interaction dynamics, with recruitment statuses ranging from completed to unknown. Together, these early-phase investigations provide preliminary safety and pharmacokinetic parameters for diabetes management research.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03616392	Completed	Diabetes Mellitus Type II	Chong Kun Dang Pharmaceutical	2018-07-25	Phase 1
NCT03601910	Unknown status	Type II Diabetes Mellitus	Chong Kun Dang Pharmaceutical	2018-07-16	Phase 1

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

Check the 2-DI-1-ASP product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Di-1-ASP selectively binds to G-quadruplex DNA structures and accumulates within mitochondria, thereby altering local fluorescent emission properties and disrupting nucleic acid transactional dynamics. This selective subcellular localization and organelle-staining capability facilitate the visualization of cellular energetics, providing critical analytical utility for investigating mitochondrial dysfunction and metabolic impairment in Type II Diabetes Mellitus.

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>).