Acelarin (NUC-1031) Clinical Trials

Size	Price	Qty
5mg	USD 417
25mg	USD 1,251

Clinical Trials

Acelarin (NUC-1031) has completed recruitment across several Phase I clinical trials evaluating safety, pharmacokinetics, and clinical activity in patients with advanced malignancies. Indications evaluated across these early-phase studies include biliary tract cancer—comprising gallbladder cancer, cholangiocarcinoma, and ampullary cancer—as well as recurrent ovarian cancer and general solid tumors. Key academic and industry sponsors supporting these completed trials include The Christie NHS Foundation Trust, Imperial College Healthcare NHS Trust, Imperial College London, and Nucana.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02351765	Completed	Biliary Tract Cancer\|Gallbladder Cancer\|Cholangiocarcinoma\|Ampullary Cancer	The Christie NHS Foundation Trust	2016-01	Phase 1
NCT02303912	Completed	Recurrent Ovarian Cancer	Imperial College Healthcare NHS Trust	2014-11	Phase 1
NCT01621854	Completed	Cancer	Imperial College London\|Nucana	2012-10	Phase 1

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

Check the Acelarin (NUC-1031) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acelarin (NUC-1031) functions as a potent nucleotide analogue that inhibits cellular DNA synthesis with an EC50 of 0.2 nM, directly disrupting DNA replication machinery. By arresting DNA chain elongation and triggering apoptotic pathways, Acelarin suppresses cancer cell proliferation, providing a therapeutic rationale for its clinical investigation in biliary tract cancer and recurrent ovarian 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>).