JNJ-64264681 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored by Janssen Research & Development, LLC are evaluating JNJ-64264681 in Phase 1 studies assessing safety, tolerability, pharmacokinetics, and pharmacodynamics across healthy volunteers and patients with solid tumors, acute myeloid leukemia, myelodysplastic syndromes, and B-cell hematologic malignancies. While early trials evaluating monotherapy and combination regimens have completed recruitment, an active open-label rollover platform clinical trial remains enrolling by invitation for ongoing safety and treatment monitoring.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06788509	ENROLLING_BY_INVITATION	Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Neoplasms; Solid Tumor, Adult; Prostatic Neoplasms, Castration-Resistant	Janssen Research & Development, LLC	2024-12-30	PHASE1
NCT04210219	COMPLETED	Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell	Janssen Research & Development, LLC	2020-07-02	PHASE1
NCT04657224	COMPLETED	Lymphoma, Non-Hodgkin; Chronic Lymphocytic Leukemia	Janssen Research & Development, LLC	2021-02-25	PHASE1
NCT03607513	COMPLETED	Healthy	Janssen Research & Development, LLC	2018-07-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the JNJ-64264681 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JNJ-64264681 acts as an orally active, irreversible covalent inhibitor of Bruton's tyrosine kinase (BTK), binding directly to the active site to block downstream B-cell receptor signaling pathways. By suppressing BTK-dependent biochemical cascades, the compound inhibits B-cell proliferation and survival, underlying its ongoing evaluation in Phase 1 clinical trials for B-cell malignancies including chronic lymphocytic leukemia and non-Hodgkin lymphoma.

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>).