Motolimod Clinical Trials

Size	Price	Qty
5mg	USD 187
25mg	USD 547

Clinical Trials

Multiple clinical trials have evaluated motolimod across diverse oncological indications, including squamous cell carcinoma of the head and neck, low-grade B-cell lymphoma, ovarian cancer, and advanced solid tumors. Ranging from Early Phase I to Phase I/II, these studies were sponsored by academic and pharmaceutical entities—such as Celgene, Stanford University, and Mayo Clinic—to test motolimod as monotherapy or alongside radiation and immune checkpoint inhibitors. While certain trials assessing pre-surgical biomarker modulation were terminated, others evaluating chemoimmunotherapy regimens have been completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04272333	TERMINATED	HNSCC	Presage Biosciences	2021-10-15	EARLY_PHASE1
NCT03906526	TERMINATED	Carcinoma, Squamous Cell	Celgene	2019-07-03	PHASE1
NCT03906526	Terminated	Carcinoma Squamous Cell	Celgene	2019-07-03	Phase 1
NCT02431559	COMPLETED	Ovarian Cancer	Ludwig Institute for Cancer Research	2015-12-02	PHASE1; PHASE2
NCT02650635	TERMINATED	Colorectal Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Recurrent Breast Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Melanoma of the Skin; Recurrent Non-Small Cell Lung Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Renal Cell Carcinoma; Solid Neoplasm; Stage IV Breast Cancer; Stage IV Non-Small Cell Lung Cancer; Stage IV Renal Cell Cancer; Stage IV Skin Melanoma; Stage IVA Colorectal Cancer; Stage IVA Pancreatic Cancer; Stage IVB Colorectal Cancer; Stage IVB Pancreatic Cancer	Mayo Clinic	2016-02-05	PHASE1
NCT02124850	TERMINATED	Squamous Cell Carcinoma of the Head and Neck	Celgene	2014-10-28	PHASE1
NCT01289210	Terminated	Low Grade B Cell Lymphoma	Celgene\|Stanford University	2011-07	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2022-04-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Motolimod selectively binds to Toll-like receptor 8 (TLR8) with high potency, stimulating downstream NF-κB signaling pathways and driving the robust production of pro-inflammatory cytokines and chemokines in myeloid cells. This localized immune activation converts immunosuppressive microenvironments into immunogenic states, mediating enhanced anti-tumor clearance in clinical contexts such as squamous cell carcinoma of the head and neck and 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>).