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Xaluritamig
Xaluritamig is a Small molecule drug developed by Amgen. It is currently in Phase 3 development. Also known as: AMG 509.
Xaluritamig is being studied in clinical trials for various conditions, including metastatic castration-resistant prostate cancer, prostate cancer, and high-risk biochemical recurrence of non-metastatic castration-sensitive prostate cancer. In one clinical trial, Xaluritamig is being compared to investigator's choice in combination with abiraterone acetate in chemotherapy-naïve metastatic castration-resistant prostate cancer patients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Xaluritamig |
|---|---|
| Also known as | AMG 509 |
| Sponsor | Amgen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer (PHASE1)
- Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) (PHASE1)
- Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (PHASE1)
- Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) (PHASE3)
- A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (PHASE3)
- Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer (PHASE1)
- Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer (PHASE1)
- Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xaluritamig CI brief — competitive landscape report
- Xaluritamig updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Xaluritamig
What is Xaluritamig?
Who makes Xaluritamig?
Is Xaluritamig also known as anything else?
What development phase is Xaluritamig in?
Related
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: AMG 509
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing