2'-Deoxyinosine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Sponsored by the biopharmaceutical company NuCana plc, a clinical trial is currently recruiting patients to evaluate nucleotide derivative therapies across early-stage Phase 1 and Phase 2 investigations. This open-label study focuses on advanced cancers, solid tumors, and lymphomas to assess safety, pharmacokinetic profiles, and dosing schedules. Through this research, investigators aim to determine preliminary clinical efficacy and therapeutic potential in patients with refractory advanced malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03829254	Recruiting	Advanced Cancer\|Lymphoma\|Solid Tumor	NuCana plc	2019-06-17	Phase 1\|Phase 2

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

Check the 2'-Deoxyinosine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a hypoxanthine nucleoside generated during DNA damage, 2'-deoxyinosine modulates intracellular purine metabolic pathways to enhance pro-apoptotic signaling mechanisms in malignant cells. This induction of programmed cell death provides the mechanistic rationale for its investigation in clinical trials evaluating therapies for advanced cancers, solid tumors, and lymphomas.

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>).