Clinical Trials

Onametostat (JNJ-64619178) has been evaluated across multiple Phase 1 clinical trials sponsored by Janssen Research & Development, LLC to investigate its safety, pharmacokinetics, and pharmacodynamics. The research program encompasses adult solid tumors, castration-resistant prostate cancer, non-Hodgkin lymphoma, myelodysplastic syndromes, acute myeloid leukemia, and B-cell chronic lymphocytic leukemia through first-in-human and open-label rollover platform designs. Overall recruitment statuses for these trials include completed, active not recruiting, and enrolling by invitation.

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
NCT03573310 COMPLETED
Neoplasms; Solid Tumor, Adult; Non-Hodgkin Lymphoma; Myelodysplastic Syndromes
Janssen Research & Development, LLC
 2018-07-13 PHASE1
NCT03573310 Active not recruiting
Neoplasms|Solid Tumor Adult|Non-Hodgkin Lymphoma|Myelodysplastic Syndromes
Janssen Research & Development LLC
 2018-07-13 Phase 1

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

Check the Onametostat (JNJ-64619178) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Onametostat (JNJ-64619178) is a potent inhibitor of protein arginine methyltransferase 5 that targets the PRMT5-MEP50 complex with subnanomolar affinity (IC50 = 0.14 nM), thereby blocking the symmetric dimethylation of arginine residues on key histone and non-histone proteins. This selective biochemical blockade impairs pre-mRNA splicing and dysregulates gene expression, suppressing tumor cell growth and demonstrating therapeutic relevance across clinical trial indications including advanced solid tumors, non-Hodgkin lymphoma, myelodysplastic syndromes, and leukemias.

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.