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Elunate®

Hutchmed · Phase 2 active Small molecule

Elunate® is a serine protease inhibitor Small molecule drug developed by Hutchmed. It is currently in Phase 2 development for Advanced or metastatic non-small cell lung cancer, Advanced or metastatic gastric cancer. Also known as: Fruquintinib.

Elunate is a small molecule inhibitor of the serine protease inhibitor, serpin family F member 5 (SERPINFB).

Elunate is a small molecule inhibitor of the serine protease inhibitor, serpin family F member 5 (SERPINFB). Used for Advanced or metastatic non-small cell lung cancer, Advanced or metastatic gastric cancer.

Likelihood of approval
13.3% 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.
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 nameElunate®
Also known asFruquintinib
SponsorHutchmed
Drug classserine protease inhibitor
TargetSERPINFB
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

Elunate works by inhibiting the activity of SERPINFB, which is involved in the regulation of angiogenesis and tumor growth. This inhibition leads to the reduction of tumor growth and metastasis.

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 Elunate®

What is Elunate®?

Elunate® is a serine protease inhibitor drug developed by Hutchmed, indicated for Advanced or metastatic non-small cell lung cancer, Advanced or metastatic gastric cancer.

How does Elunate® work?

Elunate is a small molecule inhibitor of the serine protease inhibitor, serpin family F member 5 (SERPINFB).

What is Elunate® used for?

Elunate® is indicated for Advanced or metastatic non-small cell lung cancer, Advanced or metastatic gastric cancer.

Who makes Elunate®?

Elunate® is developed by Hutchmed (see full Hutchmed pipeline at /company/hutchmed).

Is Elunate® also known as anything else?

Elunate® is also known as Fruquintinib.

What drug class is Elunate® in?

Elunate® belongs to the serine protease inhibitor class. See all serine protease inhibitor drugs at /class/serine-protease-inhibitor.

What development phase is Elunate® in?

Elunate® is in Phase 2.

What are the side effects of Elunate®?

Common side effects of Elunate® include Fatigue, Nausea, Diarrhea.

What does Elunate® target?

Elunate® targets SERPINFB and is a serine protease inhibitor.

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