Asset profile

Setidegrasib

Small molecule

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Phase 3underway

Evidence outlook · registrational

Non-Small Cell Lung Cancer: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. Registrational readout expected around 2030-06-30.

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Competitive landscape

71 competitors in this universe: 11 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 58 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Setidegrasib: this drugPhase 3Small moleculeKRAS G12D
GFH375Phase 3Small moleculeKRAS G12D
INCB161734Phase 3Small moleculeKRAS G12D
ZoldonrasibPhase 3Small moleculeKRAS G12D
VS-7375Phase 2Small moleculeKRAS G12D
ARV-806Phase 1/2Small moleculeKRAS G12D
INV-8989Phase 1/2Small moleculeKRAS G12D
QLC1101Phase 1/2Small moleculeKRAS G12D
RMC-9805Phase 1/2Small moleculeKRAS G12D
TSN1611Phase 1/2Small moleculeKRAS G12D
LT-010391Phase 1Small moleculeKRAS G12D
LY3962673Phase 1Small moleculeKRAS G12D
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET

…and 56 more. Research shows the complete landscape.

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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

(6 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 1Healthy VolunteerNot yet recruiting
Est. primary completion 2026-10-31 · NCT07773129 · CT.gov ↗
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2027 (2)
May 2027 (1)
Phase 1Healthy VolunteerActive not recruiting
Est. primary completion 2027-05-02 · NCT07395024 · CT.gov ↗
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September 2027 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-09 · NCT07483983 · CT.gov ↗
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2028 (1)
December 2028 (1)
Phase 1Solid TumorRecruiting
Est. primary completion 2028-12-31 · NCT05382559 · CT.gov ↗
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2029 (1)
August 2029 (1)
Phase 3Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic AdenocarcinomaRecruiting
Est. primary completion 2029-08-31 · NCT07409272 · CT.gov ↗
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2030 (1)
June 2030 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2030-06-30 · NCT07566052 · 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 (2)
Phase 2 (1)
Phase 1 (3)