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Drug

Adagrasib

Approved medicine
ClassGTPase KRas inhibitorResearchActive indication expansion

Also known as KRAS G12C inhibitor MRTX849, Krazati, ((2s)-4-(7-(8-chloronaphthalen-1-yl)-2-(((2s)-1- methylpyrrolidin-2-yl)methoxy)-5,6,7,8- tetrahydropyrido(3,4-d)pyrimidin-4-yl)-1-(2-fluoroprop2-enoyl)piperazin-2-yl)acetonitrile, 2-piperazineacetonitrile, 4-(7-(8-chloro-1-naphthalenyl)-5,6,7,8-tetrahydro-2-(((2s)-1-methyl-2-pyrrolidinyl)methoxy)pyrido(3,4-d)pyrimidin-4-yl)-1-(2-fluoro-1-oxo-2-propen-1-yl)-, (2s)-.

4
Research papers
15
Active clinical trials
GTPase KRas
Primary target
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Genomically-Guided Treatment Trial in Brain Metastases

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

Adagrasib in Advanced Solid Tumors Harboring a <i>KRAS</i><sup><i>G12C</i></sup> Mutation.

Research2023-04-26Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Adagrasib
Aliases & brands
KRAS G12C inhibitor MRTX849Krazati((2s)-4-(7-(8-chloronaphthalen-1-yl)-2-(((2s)-1- methylpyrrolidin-2-yl)methoxy)-5,6,7,8- tetrahydropyrido(3,4-d)pyrimidin-4-yl)-1-(2-fluoroprop2-enoyl)piperazin-2-yl)acetonitrile2-piperazineacetonitrile, 4-(7-(8-chloro-1-naphthalenyl)-5,6,7,8-tetrahydro-2-(((2s)-1-methyl-2-pyrrolidinyl)methoxy)pyrido(3,4-d)pyrimidin-4-yl)-1-(2-fluoro-1-oxo-2-propen-1-yl)-, (2s)-
RxNorm CUI
2625882
ChEMBL ID
CHEMBL4594350
ATC codes
L01XX77
UNII
8EOO6HQF8Y
Primary mechanism
GTPase KRas inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

GTPase KRas
KRAS · P01116
INHIBITORGTPase KRas inhibitor

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2022-12-12 → 2024-06-21)
Earliest approval
2022-12-12
Latest approval
2024-06-21
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-09-01Label change
Label change: ADAGRASIB (NDA216340)
Evidence ↗
2026-03-25Label change
Label change: ADAGRASIB (NDA216340)
Evidence ↗
2024-06-21Indication expansionMulti-authority
Indication expansion: ADAGRASIB (NDA216340)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-01-05Conditional marketing authorisationMulti-authority
Conditional marketing authorisation: Krazati (EMA)
Indication: Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at… Show full indication

Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

24 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
24
registered trials across all phases
LATEST COMPLETION 2025
15
Active studies
11
Recruiting
3
Late-stage (III+)
2
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 24
Early Phase 11Phase 19Phase 1 / 23Phase 28Phase 2 / 31Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2022–2024
Most influential

Adagrasib in Advanced Solid Tumors Harboring a <i>KRAS</i><sup><i>G12C</i></sup> Mutation.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 229 cites
Recent papers

Adagrasib in Advanced Solid Tumors Harboring a <i>KRAS</i><sup><i>G12C</i></sup> Mutation.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 229 cites
Major research themes8
Antineoplastic Agents2Carcinoma, Non-Small-Cell Lung2Cetuximab2Colorectal Neoplasms2Lung Neoplasms2Proto-Oncogene Proteins p21(ras)2Antineoplastic Combined Chemotherapy Protocols1Mutation1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Cancer discovery1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Der-Torossian H4
  • Velastegui K4
  • Barve M3
  • Bekaii-Saab TS3
  • Pelster MS3
  • Sabari JK3
  • Spira AI3
  • Yaeger R3
Leading institutions
free-text, unnormalised
  • Memorial Sloan Kettering Cancer Center3
  • Mayo Clinic2
  • Perlmutter Cancer Center2
  • Sarah Cannon Research Institute2
  • The University of Texas MD Anderson Cancer Center2
  • Cleveland Clinic1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 2 of the same disease areas as Adagrasib in the shared literature.

2 shared diseases2 shared papers
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.