Drug approvals · United States
FDA-approved KRAS inhibitors
Every drug the FDA has approved as a KRAS or RAS inhibitor, with the mutation it targets, the sponsor, the original approval date and the FDA approval letter.
Not medical advice. This list records regulatory approvals. What each medicine is approved to treat, and for whom, is set out in its FDA label, linked on each row; treatment decisions belong with a qualified health professional.
3 KRAS inhibitors, by approval date
A drug is listed when it has an approved US application in Drugs@FDA and its FDA label's mechanism of action calls it an inhibitor of KRAS (or of the RAS family, which includes KRAS). The date is the original approval of that application. Sort any column or download CSV.
| Drug (brand) | Target | First FDA approval | Application holder (as listed by FDA) | Application | Status | FDA label wording |
|---|---|---|---|---|---|---|
| Sotorasib (Lumakras) | KRAS G12C | 28 May 2021 | AMGEN INC | NDA 214665 | Marketed | “Sotorasib is an inhibitor of KRAS G12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS.” Label, 22 Jan 2025 |
| Adagrasib (Krazati) | KRAS G12C | 12 Dec 2022 | BRISTOL | NDA 216340 | Marketed | “Adagrasib is an irreversible inhibitor of KRAS 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.” Label, 25 Mar 2026 |
| Daraxonrasib (Rasonque) | KRAS, NRAS, HRAS | 26 Aug 2026 | REVOLUTION MEDICINES | NDA 220910 | Marketed | “Daraxonrasib is an inhibitor of the RAS GTPase family.” Label, 27 Aug 2026 |
Checked, not FDA-approved
Other KRAS inhibitors we looked up that had no approved US application in Drugs@FDA on 4 October 2026: Divarasib, Olomorasib, Glecirasib, Garsorasib, Fulzerasib, Zoldonrasib, Elironrasib. Some may be approved elsewhere, for example in China or the European Union; this list covers the United States only. Their trials are in the report KRAS and RAS inhibitors.
How this list is made
StatOrigin queries the FDA's openFDA service for Drugs@FDA applications and current drug labels. A drug is on the list only if it has an original new drug application or biologics licence application with approved status, and its FDA label's mechanism of action calls it an inhibitor of KRAS (or of the RAS family, which includes KRAS) — the quoted wording on each row, from the current label. Each listed target appears in that label. The date is the original approval of the application listed; a drug approved earlier under a different application shows the current one. Separate applications for a new formulation of a listed drug (a subcutaneous version, for example) are not listed again. Approval letters and applications link to the FDA; labels link to DailyMed, the National Library of Medicine's copy of the FDA label. Approvals by other regulators are not shown. The list was last checked on 4 October 2026; report an error through the corrections page.
For trial activity behind these drugs — studies, phases and sponsors — see KRAS and RAS inhibitors.
Other lists: FDA-approved antibody-drug conjugates · FDA-approved bispecific antibodies
Cite this list
StatOrigin. (2026). FDA-approved KRAS inhibitors. https://statorigin.org/approved-drugs/kras-inhibitors