Prescription medicine
Adagrasib Brand names: Krazati
Adagrasib (Krazati) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the adagrasib FDA label on DailyMed (effective March 25, 2026, Mirati Therapeutics, Inc); the NDA 216340 record on Drugs@FDA; every adagrasib label on DailyMed.
Highlights of the record
FDA label of March 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)*
As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Forms and strengths
- 200 mg
Coated tablet.
On the market
- Earliest approval on file
- December 12, 2022 Krazati, Bristol; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 21, 2043 Krazati tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,063 through July 30, 2026
What is adagrasib used for?
From the label: indications and usageKRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)*
As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)*
In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. […]
Conditions named in the indications of adagrasib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (KRAZATI), NDA216340 (Bristol), as published by Mirati Therapeutics, Inc, effective March 25, 2026 (SPL set 0b8bf078-34c2-4f45-9012-38a8ac082b01), via openFDA; the full label on DailyMed
Is there a generic for adagrasib (Krazati)?
No generic adagrasib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Krazati tablets: the compound patent runs to September 10, 2041, and the last listed entry to August 21, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the adagrasib label say about other medicines?
The adagrasib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cetuximab | warnings and precautions | In patients who received KRAZATI in combination with cetuximab [see Adverse Reactions (6.1) ], serious gastrointestinal adverse reactions included gastrointestinal bleeding in 8.5% including 1.1% Grade 3 or 4, gastrointestinal obstruction in 5.3% including 5.3% Grade 3 or 4, colitis in 1.1% including 1.1% Grade 3 and … |
Source: FDA drug label (KRAZATI), NDA216340 (Bristol), as published by Mirati Therapeutics, Inc, effective March 25, 2026 (SPL set 0b8bf078-34c2-4f45-9012-38a8ac082b01), via openFDA; the full label on DailyMed
What do FAERS reports show for adagrasib?
The FDA Adverse Event Reporting System holds 1,063 reports that list adagrasib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 341 are coded as a death and 401 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as adagrasib?
27 other medicines are given the same way (oral) and in the same FDA class as adagrasib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Sotorasib | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to adagrasib
- 27 medicines for the same use
- Adagrasib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other