Last reviewed 2026-04-19 · How we verify

Proxalutamide

At a glance

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness (Phase 3)
• A Phase 1/2, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC) (Phase 1)
• Anti-Androgen Treatment for COVID-19 (NA)
• Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer: an Open-label, Multi-center, Dose-escalating，Phase I/Ib Study. (Phase 1)
• Proxalutamide Treatment for Hospitalized COVID-19 Patients in Southern Brazil - The South Proxa-Rescue AndroCoV Trial (Phase 3)
• A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for Hi (Phase 2)
• Proxalutamide Treatment for Hospitalized COVID-19 Patients (Phase 3)
• An Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC Who Failed Either Abiraterone or Enzalutamide (Phase 2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Proxalutamide CI brief — competitive landscape report
• Proxalutamide updates RSS · CI watch RSS
• Suzhou Kintor Pharmaceutical Inc, portfolio CI