Tetramethylpyrazine Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate compounds in this therapeutic area across Phase 1, Phase 2, Phase 4, and non-applicable phase designations. Target indications include healthy volunteers, cocaine use disorder, fibrous dysplasia of bone, and tumor-induced osteomalacia, with recruitment statuses ranging from completed to active but non-recruiting and not yet recruiting. These initiatives are sponsored by academic and government organizations, including the National Institute on Drug Abuse and the National Institute of Dental and Craniofacial Research, alongside commercial entities like Tempero Bio Inc., Kyowa Kirin Co. Ltd., and Guangzhou Magpie Pharmaceuticals Co., Ltd.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04667013	NOT_YET_RECRUITING	Healthy	Guangzhou Magpie Pharmaceuticals Co., Ltd.	2025-09-01	PHASE1
NCT06122701	Not yet recruiting	Healthy	University Medicine Greifswald	2023-11-20	Not Applicable
NCT06025396	Completed	Cocaine Use Disorder\|Substance Use Disorders\|Healthy Volunteers	Tempero Bio Inc.\|National Institute on Drug Abuse (NIDA)	2023-01-06	Phase 1
NCT05509595	Active not recruiting	Fibrous Dysplasia Of Bone	National Institute of Dental and Craniofacial Research (NIDCR)\|National Institutes of Health Clinical Center (CC)	2022-12-07	Phase 2
NCT05357573	Active not recruiting	Tumor-Induced Osteomalacia (TIO)	Kyowa Kirin Co. Ltd.	2022-09-07	Phase 4

(data from https://clinicaltrials.gov, updated on 2025-03-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetramethylpyrazine exerts pharmacological activity by scavenging reactive oxygen species and modulating biochemical signaling pathways involved in inflammatory responses and platelet aggregation. By inhibiting pro-inflammatory cytokine release and suppressing cellular apoptotic cascades, the compound protects vascular and neural tissues, providing therapeutic relevance for managing inflammatory, vascular, and substance use disorders investigated in clinical trials.

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>).