Clinical Trials

Numerous clinical trials evaluate Resiquimod as an immune modifier and vaccine adjuvant across Early Phase 1, Phase 1, Phase 2, and non-interventional study designs. These investigations target oncological conditions—including melanoma, basal cell carcinoma, colorectal cancer, and glioblastoma—as well as allergic and inflammatory diseases such as asthma and nasal allergies. Supported by academic medical centers, health organizations, and industry sponsors, these studies encompass recruiting, active, completed, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06488118 UNKNOWN
Innate Immunity; Mucosal Immunity; Asthma; Viral Infection
Akhilesh Jha
 2024-05-24
NCT06021002 UNKNOWN
Innate Inflammatory Response; Asthma; Nasal Allergy
Cambridge University Hospitals NHS Foundation Trust
 2022-08-09
NCT01204684 COMPLETED
Glioma; Anaplastic Astrocytoma; Anaplastic Astro-oligodendroglioma; Glioblastoma
Jonsson Comprehensive Cancer Center
 2010-10-08 PHASE2
NCT06021002 Recruiting
Innate Inflammatory Response|Asthma|Nasal Allergy
Cambridge University Hospitals NHS Foundation Trust
 2022-08-09 Not Applicable
NCT00960752 COMPLETED
Melanoma
M.D. Anderson Cancer Center
 2010-05-20 PHASE2
NCT02126579 COMPLETED
Melanoma; Metastatic Melanoma; Mucosal Melanoma
Craig L Slingluff, Jr
 2014-05-01 PHASE1; PHASE2
NCT04127864 Active not recruiting
Colorectal Cancer|Surgery
University of Copenhagen|Zealand University Hospital
 2019-10-14 --
NCT02090374 COMPLETED
Allergic Rhinitis; Asthma; Latent Tuberculosis
Imperial College London
 2014-03
NCT02688478 Unknown status
Allergies
University of British Columbia
 2017-02-02 Not Applicable
NCT01676831 COMPLETED
Cutaneous T Cell Lymphoma
Abramson Cancer Center at Penn Medicine
 2012-02 PHASE1; PHASE2
NCT01748747 COMPLETED
Recurrent Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
Mayo Clinic
 2012-10 EARLY_PHASE1
NCT01583816 COMPLETED
Actinic Keratosis
Spirig Pharma Ltd.
 2012-05 PHASE2
NCT01808950 TERMINATED
Nodular Basal Cell Carcinoma
Spirig Pharma Ltd.
 2013-02 PHASE1; PHASE2
NCT01737580 COMPLETED
Influenza Vaccination in Seniors
University of British Columbia
 2013-04 PHASE1
NCT00948961 COMPLETED
Advanced Malignancies
Celldex Therapeutics
 2009-09 PHASE1; PHASE2
NCT00470379 COMPLETED
Melanoma (Skin)
Mayo Clinic
 2006-04 EARLY_PHASE1
NCT00960752 Completed
Melanoma
M.D. Anderson Cancer Center
 2010-05-20 Phase 2
NCT00821652 COMPLETED
Tumors
Nina Bhardwaj
 2009-02 PHASE1
NCT00175435 COMPLETED
Hepatitis B
University of British Columbia
 2005-08 PHASE1; PHASE2
NCT00117923 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2004-08 PHASE2
NCT00116675 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2005-03 PHASE2
NCT00115141 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2004-04 PHASE2
NCT00114920 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2004-03 PHASE2
NCT00116662 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2005-03 PHASE2
NCT00117871 COMPLETED
Warts
Graceway Pharmaceuticals, LLC
 2004-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2024-07-10)

Check the Resiquimod (R-848) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Resiquimod selectively binds to and activates Toll-like receptors 7 and 8 (TLR7/8), triggering downstream nuclear factor-κB signaling cascades and promoting the robust secretion of key cytokines such as TNF-α, IL-6, and IFN-α. This target engagement stimulates antigen-presenting cell maturation and enhances cell-mediated immune responses, establishing its clinical relevance as a topical modifier and adjuvant evaluated for melanoma, basal cell carcinoma, and viral 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>).

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Note: Technical data last updated: Sep 1, 2026.