JNJ-63576253 (TRC-253) Clinical Trials

Size	Price	Qty
5mg	USD 127

Clinical Trials

The clinical evaluation of JNJ-63576253 (TRC-253) includes a clinical trial investigating its therapeutic potential in oncology. Sponsored by Tracon Pharmaceuticals Inc. in collaboration with Janssen Pharmaceutica N.V. Belgium, this completed Phase 1/2 study evaluated the compound in patients with metastatic castrate-resistant prostate cancer and prostate adenocarcinoma. The trial assessed the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of TRC-253 as a targeted intervention for advanced prostate malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02987829	Completed	Metastatic Castrate-resistant Prostate Cancer\|Adenocarcinoma Prostate	Tracon Pharmaceuticals Inc.\|Janssen Pharmaceutica N.V. Belgium	2017-05-23	Phase 1\|Phase 2

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

Check the JNJ-63576253 (TRC-253) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JNJ-63576253 (TRC-253) acts as a potent and selective antagonist of the androgen receptor with an IC50 of 6.9 nM, binding the receptor to prevent androgen-mediated transcriptional activation and downstream oncogenic signaling. This molecular inhibition suppresses cell proliferation in both wild-type and ligand-binding domain-mutated, enzalutamide-resistant prostate cancer models, supporting its clinical evaluation in metastatic castrate-resistant prostate cancer and prostate adenocarcinoma.

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>).