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AG013736

Pfizer · Phase 2 active Small molecule Under review

AG013736 is a PD-1 inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 2 development for Non-small cell lung cancer, PD-L1 positive.

AG013736 is a small molecule that targets the PD-1 receptor.

AG013736, also known as axitinib, is a small molecule vascular endothelial growth factor receptor inhibitor. It is being studied in clinical trials for various conditions, including recurrent and metastatic adenoid cystic carcinoma, colorectal cancer, and renal cell carcinoma.

Likelihood of approval
16.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
  • Big-pharma sponsor +3.0pp
    Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameAG013736
SponsorPfizer
Drug classPD-1 inhibitor
TargetPD-1
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

By binding to PD-1, AG013736 prevents the interaction between PD-1 and its ligands, leading to the activation of T cells and enhanced anti-tumor immune response.

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 AG013736

What is AG013736?

AG013736 is a PD-1 inhibitor drug developed by Pfizer, indicated for Non-small cell lung cancer, PD-L1 positive.

How does AG013736 work?

AG013736 is a small molecule that targets the PD-1 receptor.

What is AG013736 used for?

AG013736 is indicated for Non-small cell lung cancer, PD-L1 positive.

Who makes AG013736?

AG013736 is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

What drug class is AG013736 in?

AG013736 belongs to the PD-1 inhibitor class. See all PD-1 inhibitor drugs at /class/pd-1-inhibitor.

What development phase is AG013736 in?

AG013736 is in Phase 2.

What are the side effects of AG013736?

Common side effects of AG013736 include Fatigue, Diarrhea, Nausea, Rash, Pruritus.

What does AG013736 target?

AG013736 targets PD-1 and is a PD-1 inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing