ORM-15341 Clinical Trials

Size	Price	Qty
5mg	USD 90

Clinical Trials

A clinical trial evaluated the safety, pharmacokinetics, and therapeutic outcomes of the compound in patients with castrate-resistant prostate cancer. Co-sponsored by Orion Corporation Orion Pharma and Endo Pharmaceuticals, this Phase 1/Phase 2 study has reached completed recruitment status. Consequently, this investigation constitutes the recorded clinical evaluation data for this indication.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01317641	Completed	Prostate Cancer	Orion Corporation Orion Pharma\|Endo Pharmaceuticals	2011-03	Phase 1\|Phase 2

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

Check the ORM-15341 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ORM-15341 functions as a potent and full antagonist of the human androgen receptor (hAR) with an IC50 of 38 nM and a Ki of 8 nM, effectively blocking ligand binding and downstream AR-mediated transcriptional activation. This pathway inhibition disrupts androgen-dependent gene expression and suppresses cellular proliferation, directly contributing to tumor growth control in prostate cancer.

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>).