Lentinan Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate Lentinan across early-phase human studies focusing on healthy volunteers and patients with HIV infections. These Phase 1 and Phase 2 protocols include a dose-escalation safety study in healthy subjects, a clinical trial evaluating Lentinan alongside didanosine for HIV management, and a Phase 2 trial. Sponsored by pharmaceutical entities including GlycaNova Norge AS and AJI Pharma USA, these trials have recorded recruitment statuses of completed and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00677027	UNKNOWN	Healthy	GlycaNova Norge AS	2008-02	PHASE1
NCT00002099	UNKNOWN	HIV Infections	AJI Pharma USA		PHASE2
NCT00002098	COMPLETED	HIV Infections	AJI Pharma USA		PHASE1

(data from https://clinicaltrials.gov, updated on 2008-05-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lentinan functions as a fungal polysaccharide immunomodulator that binds to host immune cell receptors, triggering downstream cytokine signaling and activating effector immune cells. This heightened immune activation enhances host defenses and anti-tumor cellular responses, providing a mechanistic rationale for its investigation in clinical studies targeting HIV infections.

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>).