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.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Lung Non-Small Cell Carcinoma | 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.conditional | approved | Jan 5, 2024 | ema |
Data updated 7 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.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 35658005
- Run
- ING-CIVIC-20260908-000001
| 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.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| 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 |