KRAZATI (adagrasib)
KRAZATI is indicated for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC); KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).
How KRAZATI Works
Adagrasib is an irreversible inhibitor that targets the KRAS G12C mutant protein by covalently binding to its mutant cysteine. This binding locks the protein in an inactive state, which prevents downstream signaling and inhibits the growth and viability of tumor cells harboring the mutation. The drug is designed to target the mutant KRAS protein without affecting the wild-type KRAS protein. When used in combination with cetuximab, the therapy has shown increased antitumor activity in KRAS G12C-mutant colorectal cancer models compared to either drug used alone.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-12-12
- Patent Cliff
- 2043
- Revenue
- $27M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
KRAZATI Approval History
What KRAZATI Treats
2 indicationsKRAZATI is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
- KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC)
KRAZATI Target & Pathway
ProTarget
KRAZATI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KRAZATI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KRAZATI treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06875310 | CA239-0004 CA2390004 | Ph 3 | recruiting | A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) |
| NCT05673187 ADEPPT | ETOP 22-22 2022-002736-31 | Ph 2 | active not recruiting | Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status |
| NCT07543172 | I-4697425 NCI-2026-02049, I-4697425 | Ph 2 | not yet recruiting | CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer |
| NCT06497556 Krascendo 1 | BO45217 2024-510908-37-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer |
| NCT07288034 | 24507 NCI-2025-09032, 24507 | Ph 2 | recruiting | Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial |
| NCT06026410 FIT-001 | KO-2806-001 | Ph 1 | recruiting | KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors |
| NCT03994796 | A071701 NCI-2019-00744, U10CA180821 | Ph 2 | active not recruiting | Genetic Testing in Guiding Treatment for Patients With Brain Metastases |
| NCT06130254 | 2022-0136 NCI-2023-09685 | Ph 1 | terminated | Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers |
| NCT07415031 | CA239-0071 EU CTR, WHO | Ph 2 | recruiting | A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies |
| NCT06248606 | HCRN LUN23-618 | Ph 2 | recruiting | Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases |
| NCT05853575 | CA239-0012 2023-503523-25, CA239-0012 | Ph 2 | active not recruiting | Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) |
| NCT04613596 | CA239-0009 CA239-0009, 849-007 | Ph 2, Ph 3 | recruiting | Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7 |
| NCT06412198 | 2023-1002 NCI-2024-04127 | Ph 1, Ph 2 | recruiting | A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations |
| NCT07382726 | 2025-1306 NCI-2026-00662 | Ph 1 | not yet recruiting | Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial |
| NCT06764771 | CA234-0001 | Ph 1 | active not recruiting | A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors |
| NCT05472623 Neo-Kan | IRB00306149 | Ph 2 | withdrawn | Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab |
| NCT06039384 | INCB99280-204 2023-503223-26-00 | Ph 1 | terminated | A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation |
| NCT06024174 results posted | CA126-0015 2023-505070-15 | Ph 1, Ph 2 | terminated | A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors |
| NCT06801418 | CA239-0020 | Ph 1 | completed | Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets |
| NCT04418661 results posted | TCD16210 U1111-1244-2555, TCD16210 | Ph 1, Ph 2 | terminated | Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies |
| NCT05840510 | CA239-0011 CA239-0011, 849-019 | Ph 1 | terminated | Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19) |
| NCT05924152 | 849-025 | Ph 1 | completed | A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib |
| NCT05848843 | 2022-0782 NCI-2023-03640 | Ph 1 | withdrawn | A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KRAZATI FDA Label Details
Indications & Usage
FDA Label (PDF)KRAZATI is indicated for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC); KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).
KRAZATI Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for KRAZATI
Revenue Insights
- • Q4-2025: $27M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 5 active patents
Trial Analysis
- • 26 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment