MedPath

Proxalutamide

Generic Name
Proxalutamide
Drug Type
Small Molecule
Chemical Formula
C24H19F4N5O2S
CAS Number
1398046-21-3
Unique Ingredient Identifier
QX6O64GP40
Background

Proxalutamide is under investigation in clinical trial NCT03899467 (The Safety and Tolerability of Proxalutamide (GT0918) in Subjects With Metastatic Castrate Resistant Prostate Cancer).

Indication

用于转移性去势抵抗性前列腺癌(mCRPC)和转移性乳腺癌患者的治疗。

The South Proxa-Rescue AndroCoV Trial Against COVID-19

Phase 3
Completed
Conditions
COVID-19
Interventions
Drug: Placebo
First Posted Date
2021-11-19
Last Posted Date
2021-11-19
Lead Sponsor
Corpometria Institute
Target Recruit Count
133
Registration Number
NCT05126628
Locations
🇧🇷

Corpometria Institute, Brasília, DF, Brazil

Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy(ADT)for High Risk Prostate Cancer

Phase 2
Conditions
Neoadjuvant Therapy \High Risk Prostate Cancer
Interventions
Other: placebo
First Posted Date
2021-10-13
Last Posted Date
2021-10-13
Lead Sponsor
Hongqian Guo
Target Recruit Count
2
Registration Number
NCT05076851
Locations
🇨🇳

The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China

A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

Phase 3
Terminated
Conditions
Covid19
Interventions
Drug: Matching placebo
Drug: Standard of care
First Posted Date
2021-08-17
Last Posted Date
2023-08-18
Lead Sponsor
Suzhou Kintor Pharmaceutical Inc,
Target Recruit Count
139
Registration Number
NCT05009732
Locations
🇨🇳

Shanghai Public Health Clinical Center, Jinshan, Shanghai, China

🇵🇭

Philippine General Hospital, Malina, Metro Malina, Philippines

🇵🇭

St. Paul's Hospital, Iloilo City, Iloilo, Philippines

and more 27 locations

Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

Phase 3
Completed
Conditions
Efficacy and Safety
Interventions
First Posted Date
2021-05-03
Last Posted Date
2024-01-02
Lead Sponsor
Suzhou Kintor Pharmaceutical Inc,
Target Recruit Count
733
Registration Number
NCT04870606
Locations
🇺🇸

Olivo Medical and Wellness Center, Chicago, Illinois, United States

🇺🇸

Absolute Clinical Research, Phoenix, Arizona, United States

🇺🇸

Long Beach Clinical Trials, Long Beach, California, United States

and more 5 locations

Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit

Phase 3
Withdrawn
Conditions
Covid19
SARS (Severe Acute Respiratory Syndrome)
Interventions
Drug: Placebo
First Posted Date
2021-04-22
Last Posted Date
2022-03-04
Lead Sponsor
Applied Biology, Inc.
Registration Number
NCT04853927
Locations
🇧🇷

Samel Hospital, Manaus, Amazonas, Brazil

Proxalutamide Treatment for COVID-19 Female Outpatients

Phase 3
Withdrawn
Conditions
Covid19
SARS-CoV Infection
Interventions
Other: Standard of Care
First Posted Date
2021-04-21
Last Posted Date
2022-03-04
Lead Sponsor
Applied Biology, Inc.
Registration Number
NCT04853134
Locations
🇧🇷

Corpometria Institute, Brasilia, Brazil

Proxalutamide Treatment for Hospitalized COVID-19 Patients

Phase 3
Completed
Conditions
Covid19
SARS (Severe Acute Respiratory Syndrome)
Interventions
Drug: Placebo
First Posted Date
2021-01-28
Last Posted Date
2021-06-24
Lead Sponsor
Applied Biology, Inc.
Target Recruit Count
645
Registration Number
NCT04728802
Locations
🇧🇷

Hospital Oscar Nicolau, Manaus, Amazonas, Brazil

🇧🇷

Hospital Raimunda Francisca Dinelli da Silva, Maues, Amazonas, Brazil

🇧🇷

Hospital Regional José Mendes, Itacoatiara, Amazonas, Brazil

and more 5 locations

Anti-Androgen Treatment for COVID-19

Not Applicable
Completed
Conditions
SARS (Severe Acute Respiratory Syndrome)
SARS-CoV2
Androgenetic Alopecia
Benign Prostatic Hyperplasia
COVID-19
Prostate Cancer
Interventions
Other: Standard of Care
First Posted Date
2020-06-24
Last Posted Date
2021-12-10
Lead Sponsor
Applied Biology, Inc.
Target Recruit Count
268
Registration Number
NCT04446429
Locations
🇧🇷

Corpometria Institute, Brasilia, Brazil

Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2019-09-26
Last Posted Date
2021-09-24
Lead Sponsor
Suzhou Kintor Pharmaceutical Inc,
Target Recruit Count
63
Registration Number
NCT04103853
Locations
🇨🇳

Sun-Yat-sen University Cancer center, Guangzhou, Fujian, China

🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

🇨🇳

Jiangsu Province Hospital, Nanjing, Jiangsu, China

and more 4 locations

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

Phase 2
Completed
Conditions
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions
First Posted Date
2019-04-02
Last Posted Date
2024-02-12
Lead Sponsor
Suzhou Kintor Pharmaceutical Inc,
Target Recruit Count
61
Registration Number
NCT03899467
Locations
🇺🇸

G U Research Network, Omaha, Nebraska, United States

🇺🇸

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

🇺🇸

Greenville Health System, Greenville, South Carolina, United States

and more 6 locations
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