12-Hydroxydodecanoic acid Clinical Trials

Size	Price	Qty
100mg	USD 119

Clinical Trials

Several clinical trials evaluate targeted therapeutic strategies across Phase 1, Phase 1/2, and Phase 2 investigations focused on solid tumors and non-small cell lung cancer. Sponsored by pharmaceutical and academic organizations—including Astellas Pharma Inc, InventisBio Co. Ltd, InxMed (Shanghai) Co. Ltd., and Fox Chase Cancer Center—the protocols range in recruitment status from actively recruiting to withdrawn. These studies primarily assess safety, tolerability, pharmacokinetics, and efficacy in patients with advanced, unresectable, or metastatic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06364696	Recruiting	Solid Tumor	Astellas Pharma Inc	2024-04-16	Phase 1
NCT06166836	Recruiting	Solid Tumor	InxMed (Shanghai) Co. Ltd.\|InventisBio Co. Ltd	2022-10-12	Phase 1\|Phase 2
NCT05492045	Recruiting	NSCLC	InventisBio Co. Ltd	2022-09-13	Phase 1\|Phase 2
NCT05400577	Withdrawn	Non-Small Cell Lung Cancer	Fox Chase Cancer Center	2022-07-13	Phase 2

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

Check the 12-Hydroxydodecanoic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

12-Hydroxydodecanoic acid binds to target cellular metabolic enzymes to disrupt downstream fatty acid oxidation pathways, consequently diminishing oncogenic signaling cascades and halting cellular proliferation. This suppression of metabolic turnover and proliferation provides a mechanistically sound basis for inhibiting tumor growth in clinical conditions such as solid tumors and non-small cell lung cancer.

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>).