IACS-010759 (IACS-10759) Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 497

Clinical Trials

Sponsored by the M.D. Anderson Cancer Center, several Phase I clinical trials evaluated IACS-010759 to assess its safety, tolerability, and preliminary therapeutic activity. A clinical trial in patients with recurrent or refractory acute myeloid leukemia was ultimately terminated during recruitment. Meanwhile, a completed clinical trial examined the inhibitor in individuals with advanced solid tumors, relapsed lymphoma, triple-negative breast carcinoma, and pancreatic ductal adenocarcinoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02882321	TERMINATED	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2016-09-29	PHASE1
NCT03291938	COMPLETED	Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Negative; HER2/Neu Negative; Metastatic Malignant Solid Neoplasm; Pancreatic Ductal Adenocarcinoma; Progesterone Receptor Negative; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Lymphoma; Refractory Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Triple-Negative Breast Carcinoma; Unresectable Solid Neoplasm	M.D. Anderson Cancer Center	2017-11-13	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-06-15)

Check the IACS-010759 (IACS-10759) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IACS-010759 selectively binds to and inhibits mitochondrial complex I, thereby disrupting mitochondrial oxidative phosphorylation and suppressing electron transport chain-dependent cellular respiration. This metabolic disruption depletes intracellular ATP levels and impairs macromolecular synthesis, ultimately suppressing cell proliferation and inducing apoptosis in metabolically vulnerable malignancies such as acute myeloid leukemia and advanced solid tumors.

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>).