Home Drugs & Interventions JSB462 History JSB462 History and Updates 13 events · 2025 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: July 31, 2026 .
JSB462 — history and updates FDA approvals, label revisions, recalls, trials, and pivotal publications FDA approvals Label revisions Recalls + safety Trials Publications 2025 2026 2027 2028 2029 2030 2031 2032 Trial: NCT07174063
2025-11-14 → 2027-06-18 (primary completion) Trial: NCT07206056
2025-10-15 → 2029-11-09 (primary completion) Trial: NCT06991556
2025-07-07 → 2032-03-29 (primary completion) Trial: NCT07047118
2025-07-03 → 2027-07-16 (primary completion) today (2026-07-10) FDA approval Label revision Recall or safety Trial activity Pivotal publication
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-10 Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for JSB462 since 2025, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones Primary completion Jan 29, 2027 · ClinicalTrials.gov
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Primary completion Jun 18, 2027 · ClinicalTrials.gov
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Primary completion Jul 16, 2027 · ClinicalTrials.gov
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Ca
Primary completion Nov 9, 2029 · ClinicalTrials.gov
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients
Primary completion Mar 29, 2032 · ClinicalTrials.gov
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Pro
Past events 2025
Trial started Nov 14, 2025 · ClinicalTrials.gov
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Trial started Oct 15, 2025 · ClinicalTrials.gov
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients
Trial registered Oct 3, 2025 · ClinicalTrials.gov
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients
Trial registered Sep 15, 2025 · ClinicalTrials.gov
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Trial started Jul 7, 2025 · ClinicalTrials.gov
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Pro
Trial started Jul 3, 2025 · ClinicalTrials.gov
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Ca
Trial registered Jul 2, 2025 · ClinicalTrials.gov
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Ca
Trial registered May 28, 2025 · ClinicalTrials.gov
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Pro
Sources FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed , filtered to high-impact journals linked to a Phase 3 trial in our inventory.