Drugs / Casdatifan
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07748988 | Sep 2026 → Jul 2030 expected | clear cell renal carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07751250 | Aug 2026 → May 2027 expected | — | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06919991 | May → Oct 2025 | — | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06191796 | Jan 2024 → May 2025 | clear cell renal carcinoma | Exelixis | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05999513 | Aug → Oct 2023 | — | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05536141 | Oct 2022 → Mar 2029 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05117554 | Nov 2021 → Feb 2023 | — | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07293351 | Mar 2026 → Nov 2029 expected | renal cell carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07227415 | Feb 2026 → Nov 2027 expected | clear cell renal carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07397611 | Mar 2026 → Jan 2028 expected | renal cell carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07011719 | Sep 2025 → Apr 2028 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07000149 | Jul 2025 → Feb 2030 expected | clear cell renal carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-01 | Arcus Biosciences, Inc. | Results New Research Published in Nature Links Clinical Activity with HIF‑2a Biology in Advanced Kidney Cancer Patients Treated with Casdatifan arcusbio.com ↗
The study showed that in ccRCC patients with HIF-2a-driven tumors, deeper suppression of HIF-2a-associated production of serum EPO correlated with clinical benefit, including higher response rates and longer PFS. |
| 2026-02-23 | Arcus Biosciences, Inc. | Results Arcus Presents New Data for its HIF-2a Inhibitor Casdatifan, Which Showed Progression-Free Survival Beyond One Year in Late-Line Kidney Cancer arcusbio.com ↗
Median progression-free survival (mPFS) was 15.1 months, and the confirmed overall response rate (cORR) increased to 45% for the 100mg QD (once daily) tablet cohort in an updated analysis of the ARC-20 study |
| 2025-10-06 | Arcus Biosciences, Inc. | Results Arcus Biosciences Presents New Data for its HIF-2a Inhibitor Casdatifan and Discloses First Inflammation Programs at Investor Event arcusbio.com ↗
In the 100mg tablet cohort, our Phase 3 dose and formulation, casdatifan showed a 35% confirmed ORR, with two additional responses pending confirmation, and mPFS had not been reached, even with a median follow-up of one year |
| 2025-06-01 | Arcus Biosciences, Inc. | Results Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response arcusbio.com ↗
Treatment with casdatifan, a HIF-2a inhibitor, plus cabozantinib, a tyrosine kinase inhibitor, showed a confirmed overall response rate (ORR) of 46% in patients who reached a minimum of 12 weeks (two scans) of follow-up |
| 2025-02-15 | Arcus Biosciences, Inc. | Results New Data Demonstrated Best-in-Class Potential for Casdatifan, a HIF-2a Inhibitor, in Patients with Metastatic Kidney Cancer arcusbio.com ↗
A 9.7-month median progression-free survival (mPFS) was reached for the 50mg twice-daily (BID) casdatifan monotherapy cohort of the Phase 1/1b ARC-20 study; mPFS was not yet reached for other cohorts |
| 2024-11-06 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update arcusbio.com ↗
Together, these data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC. |
| 2024-10-24 | Arcus Biosciences, Inc. | Results First Clinical Data for Arcus Biosciences’ HIF-2a Inhibitor, Casdatifan, Showed Promising Clinical Activity and Tumor Shrinkage in Patients with Metastatic Kidney Cancer arcusbio.com ↗
Low rate of primary progression (19%) and high rate of disease control (81%) was observed in the 100mg expansion cohort with many of those patients still on treatment |
| 2022-03-08 | Arcus Biosciences, Inc. | Results Arcus Biosciences Presents Data from its Pipeline at Multiple Scientific Conferences arcusbio.com ↗
Initial pharmacokinetic (PK)/pharmacodynamic (PD) data for AB521, Arcus’s HIF-2a inhibitor, in healthy volunteers confirm its potential to have an improved clinical profile compared to that of the only approved HIF-2a inhibitor |
| 2022-02-23 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Corporate Update arcusbio.com ↗
Initial pharmacokinetic (PK)/pharmacodynamic (PD) data for AB521, Arcus’s HIF-2a inhibitor, in healthy volunteers confirm its potential to have an improved clinical profile compared to the approved HIF-2a inhibitor; data to be presented at a conference this March |
All press releases naming this drug 23 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Casdatifan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07751250 ↗ |
| Known as | AB521 | “A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to...” NCT07751250 ↗ |
| Action | Inhibit | “highly potent and selective tetralin-based HIF-2α inhibitor” PMID 42246926 ↗ Jun 2026 |
| Modality | Small molecule | “highly potent and selective tetralin-based HIF-2α inhibitor” PMID 42246926 ↗ Jun 2026 |
| Route | Oral | “casdatifan orally with water under fasting conditions” NCT05117554 ↗ |