Indirubin (NSC 105327) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials, including a Phase 2 study, have evaluated the therapeutic efficacy, dosage optimization, and immunomodulatory mechanisms of topically applied indirubin extracts for psoriasis vulgaris. Sponsored by academic and health institutions, including Chang Gung Memorial Hospital and the National Science Council of Taiwan, these trials have completed recruitment and demonstrate the compound's potential in managing chronic inflammatory dermatological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01735864	COMPLETED	Psoriasis Vulgaris	Chang Gung Memorial Hospital	2012-11
NCT02088281	Completed	Psoriasis Vulgaris	Chang Gung Memorial Hospital\|National Science Council Taiwan	2012-11	Phase 2

(data from https://clinicaltrials.gov, updated on 2019-07-25)

Check the Indirubin (NSC 105327) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indirubin functions as a potent inhibitor of cyclin-dependent kinases and glycogen synthase kinase-3β, thereby blocking target phosphorylation, IκB degradation, and nuclear factor-kappa B nuclear translocation to suppress inflammatory signaling cascades and arrest cell proliferation. By downregulating pro-inflammatory signal transduction and cellular hyperproliferation, this mechanism provides a therapeutic rationale for its clinical evaluation in dermatological conditions such as psoriasis vulgaris.

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>).