Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by pharmaceutical entities (such as Janssen Research & Development and Provention Bio) and academic centers (including M.D. Anderson Cancer Center and the University of Oxford) have evaluated edicotinib (JNJ-40346527). These investigations assessed safety, pharmacokinetics, and efficacy across oncology, inflammatory, and neurodegenerative indications, including rheumatoid arthritis, Crohn's disease, Hodgkin lymphoma, acute myeloid leukemia, prostate adenocarcinoma, and Alzheimer's disease. Although several autoimmune and oncologic studies reached completion, others targeting leukemia and neurodegenerative conditions were terminated early.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03177460 COMPLETED
Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Testosterone Greater Than 150 ng/dL
M.D. Anderson Cancer Center
 2017-06-07 PHASE1
NCT04121208 TERMINATED
Alzheimer Disease; Mild Cognitive Impairment
University of Oxford
 2021-04-07 PHASE1
NCT04121208 Terminated
Alzheimer Disease|Mild Cognitive Impairment
University of Oxford|Janssen Pharmaceutica
 2021-04-07 Phase 1
NCT03557970 TERMINATED
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
OHSU Knight Cancer Institute
 2018-10-05 PHASE2
NCT03854305 COMPLETED
Crohn's Disease
Provention Bio, Inc.
 2018-03-20 PHASE2
NCT01572519 COMPLETED
Relapsed or Refractory Hodgkin Lymphoma
Janssen Research & Development, LLC
 2012-07-17 PHASE1
NCT01597739 COMPLETED
Arthritis, Rheumatoid
Janssen Research & Development, LLC
 2012-07 PHASE2
NCT01054014 Completed
Health
Johnson & Johnson Pharmaceutical Research & Development L.L.C.
 2010-01 Phase 1
NCT01054014 COMPLETED
Health
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-03)

Check the Edicotinib(JNJ-40346527) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Edicotinib (JNJ-40346527) is a potent, selective inhibitor of colony-stimulating factor-1 receptor (CSF-1R) that binds the receptor kinase domain to inhibit autophosphorylation and suppress downstream intracellular survival signaling cascades. By blocking CSF-1R activation, edicotinib impairs the differentiation and survival of monocyte-lineage cells, leading to decreased microglial proliferation, tumor-associated macrophage infiltration, and tissue inflammation evaluated in clinical studies for Alzheimer's disease, prostate cancer, rheumatoid arthritis, and Crohn's disease.

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.