KRAS G12C Inhibitors
2 drugsAbout KRAS G12C
KRAS G12C is a mutant form of the KRAS protein, a GTPase involved in cell signaling pathways controlling cell growth and survival. The G12C mutation creates a vulnerability exploitable by targeted therapies that irreversibly bind to the mutant protein.
KRAS G12C has emerged as a significant drug development target, evidenced by two FDA-approved drugs. However, there is currently no genetic evidence data available linking KRAS G12C to specific diseases in this dataset.
Two FDA-approved drugs, KRAZATI (Bristol-Myers Squibb) and LUMAKRAS (Amgen), target KRAS G12C. Both drugs are small molecules, with approvals spanning two therapeutic areas.
Top KRAS G12C Drugs
Bristol-Myers Squibb and Amgen are the only two companies with approved KRAS G12C-targeting drugs.
High market concentration indicates significant entry barriers, requiring substantial investment or novel approaches.
KRAS G12C Drug Modality Landscape
Modalities
Routes of Administration
KRAS G12C is amenable to small molecule drugs, with oral options available for convenient dosing.
Explore alternative modalities like PROTACs or antibodies to differentiate from existing therapies.
KRAS G12C Clinical Trials 70 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on KRAS G12C. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 39 | 12 | 12 | 15 | 50% |
| Phase 2 | 25 | 1 | 6 | 18 | 14% |
| Phase 3 | 5 | 1 | 0 | 4 | 100% |
| Phase 4 | 1 | 1 | 0 | 0 | 100% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved KRAS G12C drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting KRAS G12C. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
KRAS G12C Drug Approval Timeline (2021 - 2022)
The first drug was approved in 2021, with the most recent approval in 2022, spanning a 2-year period.
Recent approvals suggest an active area of development, but potential market saturation warrants careful consideration.
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Competitive Landscape
- • 2 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 37 (17 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on KRAS G12C. A trial counts if an approved drug acting on KRAS G12C is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.