Asset profile

Gefitinib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Non-Small Cell Lung Cancer (label: metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions)

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

How the evidence outlook works ↗

Competitive landscape

102 competitors in this universe: 41 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Gefitinib: this drugApprovedSmall moleculeEGFR
LazertinibApprovedSmall moleculeEGFR
Osimertinib (Tagrisso)ApprovedSmall moleculeEGFR
SunvozertinibApprovedSmall moleculeEGFR
AlflutinibPhase 3Small moleculeEGFR
AlmonertinibPhase 3Small moleculeEGFR
BefotertinibPhase 3Small moleculeEGFR
BPI-7711Phase 3Small moleculeEGFR
CPO301Phase 3Antibody–drug conjugateEGFR
FHND9041Phase 3Small moleculeEGFR
IcotinibPhase 3Small moleculeEGFR
JMT101Phase 3Monoclonal antibodyEGFR
LimertinibPhase 3Small moleculeEGFR, EGFR T790M (resistant mutant, selective over wild-type EGFR)
PLB1004Phase 3Small moleculeEGFR
SH-1028Phase 3Small moleculeEGFR
TY-9591Phase 3Small moleculeEGFR

…and 87 more. Research shows the complete landscape.

Research

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(4 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
October 2026 (1)
Phase 1Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2026-10-05 · NCT03333343 · CT.gov ↗
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2027 (1)
July 2027 (1)
Phase 2Advanced Solid Tumors Which Are cMET-dependentActive not recruiting
Est. primary completion 2027-07-30 · NCT03040973 · CT.gov ↗
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2028 (1)
March 2028 (1)
Phase 2Osteosarcoma, MetastasisRecruiting
Est. primary completion 2028-03 · NCT07477457 · CT.gov ↗
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2030 (1)
October 2030 (1)
Phase 1Lung CancerNot yet recruiting
Est. primary completion 2030-10-30 · NCT07458919 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (44)
Phase 2/3 (7)
Phase 2 (177)
Phase 1/2 (32)
Phase 1 (39)
Phase 4 (8)
Early phase / not applicable (13)
Used as active comparator (15)
Appears in other studies (17)