Paeoniflorin (NSC 178886) Clinical Trials

Size	Price	Qty
25mg	USD 110
1g	USD 970

Clinical Trials

Several clinical trials sponsored by academic and medical institutions, including Peking University Third Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine, evaluate paeoniflorin across acute ischemic stroke, oral lichen planus, and autoimmune hepatitis. Encompassing non-phased, Phase 2/Phase 3, and Phase 3 protocols, these studies exhibit varying recruitment statuses, including active recruitment for oral lichen planus, a study not yet recruiting for acute ischemic stroke, and a withdrawn trial in autoimmune hepatitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05973097	RECRUITING	Oral Lichen Planus	Peking University Third Hospital	2023-07-30
NCT05560152	Not yet recruiting	Ischemic Stroke Acute	Ying Gao\|Dongzhimen Hospital of Beijing University of Chinese Medicine Beijing\|Dongzhimen Hospital Beijing	2022-09-25	Phase 2\|Phase 3
NCT02878863	WITHDRAWN	Hepatitis, Autoimmune	Xiaoli Fan	2016-08	PHASE3

(data from https://clinicaltrials.gov, updated on 2023-08-02)

Check the Paeoniflorin (NSC 178886) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paeoniflorin downregulates cyclooxygenase-2 expression and inhibits hypoxia-inducible factor-1α through an mTOR-dependent pathway, thereby suppressing pro-inflammatory cytokine cascades and cellular oxidative stress. This inhibition of mediator signaling and tissue inflammation provides the mechanistic rationale for its clinical study in conditions such as acute ischemic stroke, oral lichen planus, and autoimmune hepatitis.

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>).