Clinical Trials

Proxalutamide (GT0918) has been evaluated across multiple clinical trials spanning Phase 1 through Phase 3 for indications including metastatic breast cancer, androgenetic alopecia, COVID-19, and high-risk, hormone-sensitive, or castrate-resistant prostate cancers. Sponsored by pharmaceutical entities like Suzhou Kintor Pharmaceutical Inc., research institutes, and independent investigators, these studies reflect completed, withdrawn, terminated, and unknown recruitment statuses. Key late-stage trials evaluated the safety and therapeutic efficacy of proxalutamide across distinct clinical populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05009732 TERMINATED
Covid19
Suzhou Kintor Pharmaceutical Inc,
 2021-09-30 PHASE3
NCT04869228 TERMINATED
COVID-19
Suzhou Kintor Pharmaceutical Inc,
 2021-08-04 PHASE3
NCT03899467 COMPLETED
Metastatic Castrate Resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Suzhou Kintor Pharmaceutical Inc,
 2019-05-30 PHASE2
NCT04870606 COMPLETED
Efficacy and Safety
Suzhou Kintor Pharmaceutical Inc,
 2021-03-05 PHASE3
NCT05076851 UNKNOWN
Neoadjuvant Therapy \High Risk Prostate Cancer
Hongqian Guo
 2021-06-17 PHASE2
NCT04853134 WITHDRAWN
Covid19; SARS-CoV Infection
Applied Biology, Inc.
 2020-11-01 PHASE3
NCT04853927 WITHDRAWN
Covid19; SARS (Severe Acute Respiratory Syndrome)
Applied Biology, Inc.
 2021-02-08 PHASE3
NCT04728802 COMPLETED
Covid19; SARS (Severe Acute Respiratory Syndrome)
Applied Biology, Inc.
 2021-02-01 PHASE3
NCT05126628 COMPLETED
COVID-19
Corpometria Institute
 2021-03-06 PHASE3
NCT04870606 Completed
Efficacy and Safety
Suzhou Kintor Pharmaceutical Inc
 2021-03-05 Phase 3
NCT04446429 COMPLETED
COVID-19; SARS-CoV2; Androgenetic Alopecia; Prostate Cancer; Benign Prostatic Hyperplasia; SARS (Severe Acute Respiratory Syndrome)
Applied Biology, Inc.
 2020-10-21
NCT04103853 COMPLETED
Metastatic Breast Cancer
Suzhou Kintor Pharmaceutical Inc,
 2017-09-06 PHASE1
NCT02826772 COMPLETED
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Suzhou Kintor Pharmaceutical Inc,
 2016-02-10 PHASE1
NCT03899467 Completed
Metastatic Castrate Resistant Prostate Cancer (mCRPC)|Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Suzhou Kintor Pharmaceutical Inc
 2019-05-30 Phase 2

(data from https://clinicaltrials.gov, updated on 2023-08-18)

Check the Proxalutamide (GT0918) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Proxalutamide competitively binds to the ligand-binding domain of the androgen receptor, thereby blocking androgen-mediated receptor activation and downregulating downstream gene expression. This target inhibition suppresses androgen-dependent cellular proliferation, providing the mechanism underlying its evaluation in clinical trials for metastatic castrate-resistant prostate cancer and metastatic 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.