Xaluritamig

Phase 3Small molecule

Amgen

Xaluritamig is one of 112 small molecule programs targeting Ewing sarcoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

111

Competitors

Pipeline

Status by Indication[3][1]

Indication

Ewing SarcomaActive, not recruiting

Prostate CancerActive, not recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcRecruiting

Ewing SarcomaPhase 1

Active, not recruiting

Prostate CancerPhase 3

Active, not recruiting

Metastatic Castration-Resistant Prostate CancerPhase 3

Recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Phase 1

Recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcPhase 1

Recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Xaluritamig

Amgen

Phase 3

3 2

Novantrone

Pfizer

Preclinical

5 3

Trexall

Alnylam Pharmaceuticals

Preclinical

—4

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 5

Duragesic

CCephalon

Preclinical

1 6

Viagra

VViatris Specialty LLC

Preclinical

1 7

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 8

Prednisone/prednisolone

Roche

Preclinical

3 9

Triptorelin Pamoate

Ipsen

Preclinical

2 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

—

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

Timeline

Expected Milestones

Q4 2028

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 Cancer3 trials

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT06613100·40 enrolled

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

Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT06555796·50 enrolled

Ewing sarcoma1 trial

Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)

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

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

Sources

References

[1]
ClinicalTrials.gov — 7 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

Q4 2028

Q3 2029

Q1 2030

Q2 2030

Trials by Indication[1]

Prostate Cancer3 trials

Ewing sarcoma1 trial

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

References

Drug Info

Quick Facts

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