Xaluritamig

Phase 3Small molecule

Xaluritamig is one of 66 small molecule programs targeting Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcRecruiting

Ewing SarcomaRecruiting

Prostate CancerRecruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Phase 1

Recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcPhase 1

Recruiting

Ewing SarcomaPhase 1

Recruiting

Prostate CancerPhase 3

Recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Zoladex

TTerSera Therapeutics LLC

Phase 3

35 2

Alinamin

Roche

Phase 3

6 3

Truqap

AstraZeneca

Phase 3

2 4

Acetylsalicylic Acid

Bayer

Phase 3

2 5

Xaluritamig

Amgen

Phase 3

4 6

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase 3

1 7

Piflufolastat

Novartis

Phase 3

2 8

Antibiotic Prophylaxis

AAssistance Publique - Hôpitaux de Paris

Phase 3

1 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

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

Timeline

Expected Milestones

Q2 2029

Phase 1Active, not recruiting

Prostate Cancer

NCT06555796

Q3 2029

Phase 3Recruiting

Prostate Cancer

NCT06691984

Q1 2030

Phase 1Recruiting

Prostate Cancer

NCT06613100

Phase 1Recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)

NCT07140900

Q2 2030

Phase 1Recruiting

Ewing Sarcoma

NCT07297979

Clinical

Trials by Indication[1]

Prostate Cancer4 trials

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Recruiting· Amgen logo

Amgen·Phase 3·NCT06691984·675 enrolled

A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT06555796·50 enrolled

LuX: A Feasibility Study of Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan

Not yet recruiting·TThomas Jefferson University·Phase 2·NCT07737925·30 enrolled

Show 1 more trial

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT06613100·40 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT07493512·40 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 3·NCT07213674·750 enrolled

Ewing sarcoma1 trial

A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Xaluritamig in Adult, Adolescent and Pediatric Participants With Relapsed or Refractory Ewing Sarcoma

Recruiting· Amgen logo

Amgen·Phase 1·NCT07297979·50 enrolled

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT07140900·60 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Xaluritamig. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Xaluritamig compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Xaluritamig. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Amgen

Xaluritamig

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2029

Q3 2029

Q1 2030

Q2 2030

Trials by Indication[1]

Prostate Cancer4 trials

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

Ewing sarcoma1 trial

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

References

Drug Info

Quick Facts

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