3'-Fluoro-3'-deoxythymidine (Alovudine) Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials are currently evaluating applications related to this agent or associated diagnostic regimens, predominantly as early-stage Phase 1 studies. These protocols focus on hematologic malignancies—including adult acute myeloid leukemia, acute lymphocytic leukemia, ambiguous lineage leukemia, and myeloma—as well as obstetrical conditions such as severe preeclampsia and preterm birth complications. Sponsored by commercial entities and academic medical centers, these trials are either actively recruiting or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05947344	Recruiting	AML Adult	Zhejiang ACEA Pharmaceutical Co. Ltd.	2023-12-08	Phase 1
NCT05232994	Not yet recruiting	Preeclampsia Severe\|Preeclampsia Second Trimester\|Preterm Birth Complication	Christiana Care Health Services	2023-03-01	Phase 1
NCT05697510	Recruiting	Acute Myeloid Leukemia (AML)	Nantes University Hospital	2023-03-16	Phase 1
NCT03633955	Recruiting	Acute Lymphocytic Leukemia\|Acute Myeloid Leukemia\|Ambiguous Lineage Leukemia or Lymphoma\|Myeloma	University of Oklahoma\|Emory University	2023-01-19	Phase 1

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

Check the 3'-Fluoro-3'-deoxythymidine (Alovudine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

3'-Fluoro-3'-deoxythymidine incorporates as a nucleoside analog that binds to and inhibits DNA polymerase γ and reverse transcriptase, thereby blocking DNA elongation and nucleic acid synthesis. This inhibition halts cellular proliferation and induces cell cycle arrest in rapidly dividing cells, which underlies its utility in monitoring and treating hematologic malignancies such as acute myeloid leukemia.

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>).