Trial started· ClinicalTrials.gov
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810),
Pidnarulex History and Updates
15 events · 2022 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
15
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-17Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Pidnarulex since 2022, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
Primary completion· ClinicalTrials.gov
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810),
Primary completion· ClinicalTrials.gov
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growt
Primary completion· ClinicalTrials.gov
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Past events
2026
Trial started· ClinicalTrials.gov
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Trial started· ClinicalTrials.gov
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growt
2025
Trial registered· ClinicalTrials.gov
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810),
Trial registered· ClinicalTrials.gov
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growt
Trial registered· ClinicalTrials.gov
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Trial started· ClinicalTrials.gov
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
2024
Trial registered· ClinicalTrials.gov
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
Primary completion· ClinicalTrials.gov
Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer
2022
Trial started· ClinicalTrials.gov
Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer
Trial registered· ClinicalTrials.gov
Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer
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.