Clinical Trials

Multiple clinical trials evaluate the therapeutic application and pharmacological profile of deutenzalutamide (HC-1119/MDV3100) across Phase 1 and Phase 3 evaluations. These studies focus on hormone refractory prostate cancer, COVID-19 respiratory infection, and pharmacokinetic assessments in healthy participants, individuals with renal impairment, or drug-drug interactions. Led by industry sponsors such as Hinova Pharmaceuticals, Applied Biology Inc., Astellas Pharma, Medivation, and Pfizer, overall recruitment statuses include completed investigations as well as trials with an unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04986176 Unknown status
COVID-19 Respiratory Infection
Applied Biology Inc.|Hinova Pharmaceuticals Inc.
 2022-04-15 Phase 3
NCT01901133 Completed
Pharmacokinetics of MDV3100|Healthy Subjects|Kidney Diseases
Astellas Pharma Europe B.V.|Medivation Inc.|Astellas Pharma Inc
 2011-10 Phase 1
NCT01913379 Completed
Healthy Subjects|Pharmacokinetics|Drug-Drug Interaction
Astellas Pharma Europe B.V.|Medivation Inc.|Astellas Pharma Inc
 2011-08 Phase 1
NCT01911715 Completed
Healthy Subjects|Pharmacokinetics of MDV3100
Astellas Pharma Europe B.V.|Medivation Inc.|Astellas Pharma Inc
 2011-04 Phase 1
NCT00510718 Completed
Prostate Cancer|Hormone Refractory Prostate Cancer
Pfizer|Astellas Pharma Inc|Medivation LLC a wholly owned subsidiary of Pfizer Inc.
 2007-07-23 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deutenzalutamide acts as a potent androgen receptor antagonist that selectively binds to the receptor's ligand-binding domain, thereby preventing androgen binding, nuclear translocation, and downstream DNA interaction. This biochemical blockade inhibits androgen-regulated gene expression and halts tumor cell proliferation, demonstrating direct therapeutic relevance for controlling hormone refractory prostate cancer in clinical settings.

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.