Proxalutamide

Overview

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。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The South Proxa-Rescue AndroCoV Trial Against COVID-19	2021/11/19	NCT05126628	Phase 3	Completed	Corpometria Institute
Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer	2021/10/13	NCT05076851	Phase 2	UNKNOWN	Hongqian Guo
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects	2021/08/17	NCT05009732	Phase 3	Terminated	Suzhou Kintor Pharmaceutical Inc,
Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness	2021/05/03	NCT04870606	Phase 3	Completed	Suzhou Kintor Pharmaceutical Inc,
Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit	2021/04/22	NCT04853927	Phase 3	Withdrawn	Applied Biology, Inc.
Proxalutamide Treatment for COVID-19 Female Outpatients	2021/04/21	NCT04853134	Phase 3	Withdrawn	Applied Biology, Inc.
Proxalutamide Treatment for Hospitalized COVID-19 Patients	2021/01/28	NCT04728802	Phase 3	Completed	Applied Biology, Inc.
Anti-Androgen Treatment for COVID-19	2020/06/24	NCT04446429	Not Applicable	Completed	Applied Biology, Inc.
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer	2019/09/26	NCT04103853	Phase 1	Completed	Suzhou Kintor Pharmaceutical Inc,
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC	2019/04/02	NCT03899467	Phase 2	Completed	Suzhou Kintor Pharmaceutical Inc,

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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