Xaluritamig
AMGEN INC AMGN · Metastatic Castration-resistant Prostate Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AMGEN INC AMGN Source: Company record for AMGEN INC (opens in a new tab)
- Indication
- Metastatic Castration-resistant Prostate Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 9 Dec 20242 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Xaluritamig. Editors add each one with its source.
Filed application
No filed application is on record for Xaluritamig. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Xaluritamig.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07213674ClinicalTrials.gov record for NCT07213674 (opens in a new tab) | A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer | Phase 3 | Recruiting | 750 (estimated) | 7 Jan 2030 (estimated) | No |
| NCT06691984ClinicalTrials.gov record for NCT06691984 (opens in a new tab) | Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) | Phase 3 | Active, not recruiting | 707 (actual) | 2 Jan 2029 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Xaluritamig.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT07213674 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06691984 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.