Casdatifan

Phase 2Small molecule

Arcus Biosciences

Casdatifan is one of 82 small molecule programs targeting Hepatic Impairment. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Hepatic ImpairmentRecruiting

ImmunotherapyRecruiting

Advanced Clear Cell Renal Cell CarcinomaActive, not recruiting

Clear Cell Renal Cell CarcinomaRecruiting

Advanced Renal Cell Carcinoma (RCC)Recruiting

Hepatic ImpairmentPhase 1

Recruiting

ImmunotherapyPhase 2

Recruiting

Advanced Clear Cell Renal Cell CarcinomaPhase 1

Active, not recruiting

Clear Cell Renal Cell CarcinomaPhase 1

Recruiting

Advanced Renal Cell Carcinoma (RCC)Preclinical

Recruiting

Competition

Competitive Landscape

76 competitors in Immunotherapy

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

21 2

Keytruda

Merck & Co.

Phase 3

16 3

Tecentriq

Roche

Phase 3

8 4

Taxol

Teva

Phase 3

3 5

Paraplatin

AAvyxa

Phase 3

6 6

Yervoy

Bristol-Myers Squibb

Phase 2

8 7

Imfinzi

AstraZeneca

Phase 2

5 8

Herceptin

Roche

Phase 2

4 9

Abraxane

Bristol-Myers Squibb

Phase 2

3 10

Trexall

Jazz Pharmaceuticals

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Advanced Clear Cell Renal Cell Carcinoma

NCT07000149

Q2 2027

Phase 1Recruiting

Hepatic Impairment

NCT07751250

Q4 2028

PreclinicalRecruiting

Carcinoma, Renal Cell

NCT07227415

Q1 2029

Phase 1Recruiting

Clear Cell Renal Cell Carcinoma

NCT05536141

Clinical

Trials by Indication[1]

Clear Cell Renal Cell Carcinoma2 trials

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05536141·362 enrolled

A Pilot Study of HIF-Mediated Gene Expression Changes in Casdatifan-Treated Refractory Renal Cell Carcinoma

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT07748988·12 enrolled

Interaction1 trial

Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT06919991·14 enrolled

Immunotherapy1 trial

Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC

Recruiting·—·Phase 2·NCT07397611·32 enrolled

Oral1 trial

Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05117554·70 enrolled

Adult1 trial

A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05999513·24 enrolled

6 more indications

Metastatic Clear Cell Renal Cell Carcinoma1 trial

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 3·NCT07011719·720 enrolled

Advanced Renal Cell Carcinoma (RCC)1 trial

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT07293351·474 enrolled

Carcinoma, Renal Cell1 trial

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Recruiting· Pfizer logo

Pfizer·Preclinical·NCT07227415·224 enrolled

Hepatic Impairment1 trial

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 Healthy Matched Participants

Recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT07751250·16 enrolled

Advanced Clear Cell Renal Cell Carcinoma1 trial

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT07000149·9 enrolled

Unspecified1 trial

A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT07641881·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Casdatifan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Casdatifan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Casdatifan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Arcus Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Arcus Biosciences

Casdatifan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2028

Q1 2029

Trials by Indication[1]

Clear Cell Renal Cell Carcinoma2 trials

Interaction1 trial

Immunotherapy1 trial

Oral1 trial

Adult1 trial

Metastatic Clear Cell Renal Cell Carcinoma1 trial

Advanced Renal Cell Carcinoma (RCC)1 trial

Carcinoma, Renal Cell1 trial

Hepatic Impairment1 trial

Advanced Clear Cell Renal Cell Carcinoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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