Cordycepin Clinical Trials

Size	Price	Qty
25mg	USD 170
100mg	USD 570

Clinical Trials

Multiple clinical trials across Phase 1, Phase 1/2, and Phase 2 evaluate the therapeutic efficacy, combination regimens, and immunological effects of cordycepin. Sponsored by academic institutions and pharmaceutical entities, these studies focus primarily on refractory terminal deoxynucleotidyl transferase (TdT)-positive leukemia, advanced solid tumors, and cancer-associated lymphopenia. Recruitment statuses across these protocols range from completed and actively recruiting to not yet recruiting and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07258160	RECRUITING	Solid Cancer; Lymphopenia	Second Affiliated Hospital of Soochow University	2025-12-01	PHASE2
NCT07002502	NOT_YET_RECRUITING	Cancer; Solid Cancer	Second Affiliated Hospital of Soochow University	2025-06-15	PHASE2
NCT00709215	UNKNOWN	Refractory TdT-Positive Leukemia	OncoVista, Inc.	2008-06	PHASE1; PHASE2
NCT00709215	Unknown status	Refractory TdT-Positive Leukemia	OncoVista Inc.\|AAIPharma	2008-06	Phase 1\|Phase 2
NCT00003005	COMPLETED	Leukemia	Boston Medical Center	1997-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an adenosine analogue, cordycepin is intracellularly phosphorylated into its mono-, di-, and triphosphate derivatives, which prematurely terminate RNA chain elongation and disrupt key purine metabolic pathways. This inhibition halts cellular macromolecular synthesis and induces apoptosis, providing the mechanistic rationale for its clinical evaluation in patients with hematologic malignancies such as TdT-positive 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>).