Drug · Small Molecule

Adagrasib

CI-DRUG-00000038Explore in graph →NCIt C157493 CHEMBL4594350 CIViC Approved

Regulatory

Approvals (5)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-06-21 (see label)	approved	Jun 21, 2024	openfda
US FDA	Malignant Colorectal Neoplasm	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.	approved	Dec 12, 2022	openfda
US FDA	—	*These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.accelerated	approved	Dec 12, 2022	openfda
US FDA	Lung Non-Small Cell Carcinoma

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	19	9	5	33	5	EU, US	Dec 12, 2022	Jan 15, 2019
Malignant Lung Neoplasm	Approved	Phase 3	11	6	4	17	2	EU, US	Dec 12, 2022	Dec 2, 2020
Malignant Colon Neoplasm	Phase1	Phase 1	1	0	0	2	0	—	—	Jul 28, 2021
Malignant Kidney Neoplasm	Phase1	Phase 1	1	1	0	1	0

Curated evidence

Clinical evidence (4)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–4 of 4 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KRAS G12C4
Adagrasib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (34)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–34 of 34 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03994796	Genetic Testing in Guiding Treatment for Patients With Brain Metastases	active not recruiting	Phase 2	50	Alliance for Clinical Trials in OncologyOTHER	1	Sep 28, 2026	clinicaltrials
NCT04793958	Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)	active not recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: GTPase KRas inhibitor
Targets: 1 gene
UNII: 8EOO6HQF8Y
Aliases: Adagrasib, ADAGRASIB (MRTX849), COMPOUND 20, KRAS G12C Inhibitor MRTX849, Krazati, KRAZATI, MRTX 849, MRTX-849, MRTX849

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX77	Other antineoplastic agents
EMA product	EMEA/H/C/006013	Krazati

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.