NDAORALTABLET
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
6/8 — Strong
KRAZATI (adagrasib) by Bristol Myers Squibb is g12c that covalently binds to the mutant cysteine in kras g12c and locks the mutant kras protein in its inactive state that prevents downstream signaling without affecting wild-type kras protein. First approved in 2022.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KRAZATI (adagrasib) is an oral small-molecule KRAS G12C inhibitor approved by the FDA in December 2022 for treating cancers with KRAS G12C mutations. The drug covalently binds to mutant KRAS G12C, locking it in an inactive state to prevent downstream signaling while sparing wild-type KRAS. It demonstrates enhanced antitumor activity when combined with cetuximab in colorectal cancer models.
$0.023BPart D
Peak17.2 years to LOEDrug is in peak commercial stage with early market penetration; brand teams should expect stable to growing headcount supporting oncology field infrastructure.
Mechanism of Action
G12C that covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive state that prevents downstream signaling without affecting wild-type KRAS protein. Adagrasib inhibited tumor cell growth and viability in cells harboring KRAS G12C mutations and resulted…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
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
Started Sep 2024
338 enrolled
Non-Small Cell Lung CancerKRAS G12C Lung Cancer
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
Started Dec 2023
6 enrolled
Advanced Solid Tumors
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
Started Nov 2023
5 enrolled
Advanced Solid Tumors
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
Started Apr 2023
0Lung CancerGastro-intestinal Cancer
Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab
Started Mar 2023
0Resectable Non-Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.