Clinical Trials

The clinical evaluation of Serdemetan (JNJ-26854165) comprises several Phase I clinical trials sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. These industry-sponsored studies investigated the safety profile, pharmacokinetics, and pharmacodynamics of the agent in patients presenting with neoplasms, specifically advanced or refractory solid tumors. Having completed recruitment, these trials establish essential preliminary safety and pharmacological benchmarks for Serdemetan in human cancer therapy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00676910 Completed
Neoplasms
Johnson & Johnson Pharmaceutical Research & Development L.L.C.
 2006-11 Phase 1
NCT00676910 COMPLETED
Neoplasms
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2006-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Serdemetan (JNJ-26854165) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Serdemetan (JNJ-26854165) acts as an HDM2 antagonist that blocks the binding of the HDM2-p53 complex to the proteasome, thereby preventing p53 degradation and restoring p53-mediated signaling and apoptosis. By reactivating tumor suppressor pathways and inhibiting cellular proliferation, this molecular mechanism provides the therapeutic foundation for suppressing oncogenic growth in clinical trials for advanced neoplasms and solid tumors.

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.