Clinical Trials

Multiple clinical trials have evaluated Orteronel (TAK-700) across Phase 1, Phase 1/2, and Phase 2 stages to assess safety, pharmacodynamics, and combination regimens in metastatic and nonmetastatic castration-resistant prostate cancer as well as post-menopausal hormone-receptor-positive breast cancer. Sponsored by industry and academic entities including Millennium Pharmaceuticals, Takeda, and the University of Wisconsin Madison, all of these studies have reached completed status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01808040 Completed
Post Menopausal Hormone Receptor Positive Breast Cancer
University of Wisconsin Madison|Millennium Pharmaceuticals Inc.
 2012-11 Phase 1
NCT01666314 Completed
Prostate Cancer
Millennium Pharmaceuticals Inc.|Takeda
 2012-08-20 Phase 1|Phase 2
NCT01549951 Completed
Prostate Cancer
Millennium Pharmaceuticals Inc.
 2012-05 Phase 2
NCT01084655 Completed
Prostate Cancer
Millennium Pharmaceuticals Inc.|Takeda
 2010-07 Phase 1|Phase 2
NCT01046916 Completed
Prostate Cancer
Millennium Pharmaceuticals Inc.
 2010-05 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Orteronel (TAK-700) selectively binds to and inhibits human 17,20-lyase, a key enzyme in steroidal hormone synthesis, thereby blocking the downstream conversion of steroid precursors into circulating androgens in both adrenal and testicular tissues. This suppression of androgen biosynthesis deprives hormone-dependent malignant cells of essential growth signals, thereby suppressing tumor cell proliferation in clinical indications such as prostate cancer and hormone receptor-positive breast 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>).

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Note: Technical data last updated: Sep 1, 2026.