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XL092

UNC Lineberger Comprehensive Cancer Center · Phase 3 active Small molecule

XL092 is a CDK4/6 inhibitor Small molecule drug developed by UNC Lineberger Comprehensive Cancer Center. It is currently in Phase 3 development for Metastatic breast cancer. Also known as: Zanzalintinib.

XL092 is a small molecule inhibitor of the CDK4/6 pathway.

XL092 is a small molecule inhibitor of the CDK4/6 pathway. Used for Metastatic breast cancer.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameXL092
Also known asZanzalintinib
SponsorUNC Lineberger Comprehensive Cancer Center
Drug classCDK4/6 inhibitor
TargetCDK4/6
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

By inhibiting CDK4/6, XL092 disrupts the cell cycle progression, leading to cell cycle arrest and apoptosis in cancer cells. This mechanism is particularly effective in treating certain types of cancer, such as breast cancer.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about XL092

What is XL092?

XL092 is a CDK4/6 inhibitor drug developed by UNC Lineberger Comprehensive Cancer Center, indicated for Metastatic breast cancer.

How does XL092 work?

XL092 is a small molecule inhibitor of the CDK4/6 pathway.

What is XL092 used for?

XL092 is indicated for Metastatic breast cancer.

Who makes XL092?

XL092 is developed by UNC Lineberger Comprehensive Cancer Center (see full UNC Lineberger Comprehensive Cancer Center pipeline at /company/unc-lineberger-comprehensive-cancer-center).

Is XL092 also known as anything else?

XL092 is also known as Zanzalintinib.

What drug class is XL092 in?

XL092 belongs to the CDK4/6 inhibitor class. See all CDK4/6 inhibitor drugs at /class/cdk4-6-inhibitor.

What development phase is XL092 in?

XL092 is in Phase 3.

What are the side effects of XL092?

Common side effects of XL092 include Diarrhea, Fatigue, Nausea.

What does XL092 target?

XL092 targets CDK4/6 and is a CDK4/6 inhibitor.

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