Ochromycinone (STA-21) Clinical Trials

Size	Price	Qty
1mg	USD 167
25mg	USD 997

Clinical Trials

The clinical evaluation of Ochromycinone (STA-21) is documented in a clinical trial evaluating a topical ointment formulation in patients with psoriasis. Sponsored by Kochi University, this completed combined Phase 1 and Phase 2 study used an intrapatient comparison design to assess the therapeutic response of psoriatic skin lesions. This work represents an initial effort to evaluate the efficacy of local STAT3 inhibition for inflammatory skin conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01047943	COMPLETED	Psoriasis	Kochi University	2007-06	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2010-01-13)

Check the Ochromycinone (STA-21) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ochromycinone (STA-21) selectively binds to signal transducer and activator of transcription 3 (STAT3), preventing its dimerization, nuclear translocation, and subsequent transcriptional activation of downstream pro-inflammatory genes. By inhibiting STAT3-driven keratinocyte hyperproliferation and immune cell recruitment, this molecular blockade reduces cutaneous inflammation associated with psoriasis.

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>).