trans-Aconitic acid Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials evaluate indications across oncology, cardiovascular disorders, chronic pain, and inflammatory skin conditions. Sponsored by academic institutions such as Baylor College of Medicine and industry entities like Innovaderm Research, these investigations incorporate Phase 1 and Phase 4 protocols as well as observational studies. Currently recruiting and active studies focus on therapeutic and diagnostic strategies for pediatric lymphomas, solid tumors, thoracic aortic aneurysms, fibromyalgia, and atopic dermatitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05134740	Recruiting	Hodgkins Lymphoma\|Non Hodgkins Lymphoma	Baylor College of Medicine\|Center for Cell and Gene Therapy Baylor College of Medicine	2024-04	Phase 1
NCT06353607	Recruiting	Acute Aortic Dissection\|Thoracic Aortic Aneurysm	University Hospital Basel Switzerland	2024-04-08	--
NCT06286358	Recruiting	Aortic Valve Disease\|Aortic Aneurysm	Université Libre de Bruxelles\|Erasme University Hospital	2024-03-07	--
NCT06208514	Recruiting	Fibromyalgia	University of Michigan	2024-03-04	Not Applicable
NCT05812027	Recruiting	Head and Neck Cancer\|Cervical Cancer\|Non Small Cell Lung Cancer\|Melanoma\|Ovarian Cancer\|HPV16 Related Cancers	TScan Therapeutics Inc.	2023-06-26	--
NCT05844618	Recruiting	Atopic Dermatitis	Innovaderm Research Inc.	2023-05-09	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

trans-Aconitic acid acts by binding to critical metabolic enzymatic targets, thereby blocking downstream pro-inflammatory signaling pathways and cellular energy production. This metabolic inhibition impairs dysregulated cell survival and inflammatory responses, conferring therapeutic potential against clinical conditions under study such as lymphomas, solid tumors, and dermatological inflammatory diseases.

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>).