Clinical Trials

Several clinical trials evaluate this compound across diverse indications, including solid tumors such as recurrent and stage I through IV uterine corpus carcinoma and Lynch syndrome, surgical recovery in colorectal disorders, and adolescent post-traumatic stress disorder. Sponsored by institutions including the National Cancer Institute, the Gynecologic Oncology Group Foundation, the University of Alabama at Birmingham, and the University of California Los Angeles, these studies encompass Phase 2, non-applicable, and unassigned phase designs. Currently, all of these trials maintain a recruitment status of not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT01164735 Not yet recruiting
Recurrent Uterine Corpus Carcinoma|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT06356558 Not yet recruiting
Surgery|Health Knowledge Attitudes Practice|Colorectal Disorders
University of Alabama at Birmingham|National Cancer Institute (NCI)
2026-05 Not Applicable
NCT06353282 Not yet recruiting
PTSD Post Traumatic Stress Disorder|Adolescents|Psychotherapy
University of California Los Angeles
2025-07-01 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Citraconic acid selectively interacts with enzymes governing branched-chain fatty acid metabolism, disrupting downstream cellular lipid synthesis and impairing critical energy production pathways within target cells. This metabolic inhibition suppresses energy-dependent cellular viability and proliferation, providing key mechanistic insight into targeting aggressive neoplastic growth such as uterine corpus carcinoma.

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>).

Note: Technical data last updated: Sep 1, 2026.