Casdatifan History and Updates

24 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
24
Trial Milestones
0
Pivotal Publications
Casdatifan — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202220232024202520262027202820292030Trial: NCT07641881 2026-06-30 → 2026-07-31 (primary completion)Trial: NCT07397611 2026-03-09 → 2028-01-31 (primary completion)Trial: NCT07011719 2025-09-08 → 2028-04-30 (primary completion)Trial: NCT07000149 2025-07-28 → 2030-02-21 (primary completion)Trial: NCT06919991 2025-05-02 → 2025-10-18 (primary completion)Trial: NCT05999513 2023-08-21 → 2023-10-31 (primary completion)Trial: NCT05536141 2022-10-26 → 2029-03-31 (primary completion)Trial: NCT05117554 2021-11-09 → 2023-02-17 (primary completion)today (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Casdatifan since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07641881
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07641881
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07011719
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05536141
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07000149
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

Past events

2026
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07011719
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07000149
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
2023
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05999513
A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05117554
Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers
2022
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05536141
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05117554
Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

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.