Adagrasib History and Updates

86 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Adagrasib since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2026

Label revisionKRAZATI Label Updated for KRAS G12C-Mutated NSCLC Indication· Mar 25, 2026

2025

Results postedAdagrasib Combination Trial for KRAS G12C Tumors Terminated; No DLTs Reported· Jul 22, 2025
Results postedAdagrasib Combination Trial for Metastatic Neoplasm Terminated· Apr 20, 2025

Upcoming & expected milestones

Trial startedJul 1, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07382726

Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial

Primary completionJul 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Primary completionOct 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT03994796

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Primary completionFeb 25, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06248606

Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

Primary completionOct 15, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Primary completionNov 14, 2027· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Primary completionDec 24, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT07382726

Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial

Primary completionFeb 16, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07415031

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Primary completionOct 8, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07288034

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV N

Primary completionOct 31, 2028· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients Wit

Primary completionMar 1, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06412198

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

Primary completionJun 1, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Primary completionSep 7, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06875310

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously U

Primary completionJun 9, 2032· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients Wit

Past events

2026

Trial startedJun 10, 2026· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Trial startedJun 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Primary completionJun 1, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05609578

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Trial startedMay 16, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07415031

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Trial registeredApr 21, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07543172

CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer

Trial startedApr 8, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07288034

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV N

FDA approval (supplemental)Mar 25, 2026· FDA

FDA approved supplemental application for Krazati (adagrasib) — Labeling (NDA 216340 S-9)

Sponsor: BRISTOL. Class: Labeling.

Label revisionMar 25, 2026· FDA

Indication and usage updated on KRAZATI label (effective 2026-03-25)

1 INDICATIONS AND USAGE KRAZATI 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

Trial registeredFeb 17, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07415031

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Trial registeredFeb 3, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07382726

Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial

Trial registeredJan 6, 2026· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT07318389

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

2025

Primary completionDec 24, 2025· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05375994

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

Trial registeredDec 17, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07288034

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV N

Primary completionJul 28, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05673187

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

Results postedJul 22, 2025· ClinicalTrials.gov

Trial results posted: NCT06024174

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G

Primary completionJun 19, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06801418

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Primary completionJun 1, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05472623

Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Trial startedApr 24, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06875310

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously U

Results postedApr 20, 2025· ClinicalTrials.gov

Trial results posted: NCT04418661

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Primary completionApr 11, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06039384

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Trial startedMar 25, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Trial registeredMar 13, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06875310

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously U

Trial startedFeb 4, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06801418

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Trial registeredJan 30, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06801418

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Trial registeredJan 8, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

2024

Primary completionDec 27, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05840510

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Trial startedSep 23, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

Trial startedAug 28, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06412198

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

Trial startedAug 6, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06248606

Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

Trial registeredJul 11, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi

FDA approval (supplemental)Jun 21, 2024· FDA

FDA approved supplemental application for Krazati (adagrasib) — Efficacy (NDA 216340 S-5)

Sponsor: BRISTOL. Class: Efficacy.

Primary completionJun 14, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06130254

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mut

Trial registeredMay 14, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06412198

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

Primary completionMay 13, 2024· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06024174

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G

Primary completionApr 4, 2024· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04418661

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Trial startedFeb 16, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Trial registeredFeb 8, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06248606

Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

Trial startedJan 30, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06130254

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mut

Primary completionJan 16, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05848843

A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KR

2023

Trial startedDec 28, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06039384

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Trial registeredNov 14, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06130254

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mut

Trial startedNov 9, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06024174

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G

Trial startedOct 18, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Trial registeredSep 15, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06039384

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Trial registeredSep 7, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Trial registeredSep 6, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06024174

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G

Primary completionAug 9, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05924152

A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Trial startedAug 7, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05840510

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Trial startedJun 29, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05924152

A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Trial registeredJun 29, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05924152

A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Trial startedJun 12, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05673187

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

Trial registeredMay 10, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Trial registeredMay 8, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05848843

A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KR

Trial registeredMay 3, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05840510

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Trial startedApr 25, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05848843

A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KR

Trial startedMar 21, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05472623

Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Trial registeredJan 6, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05673187

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

2022

FDA approvalDec 12, 2022· FDA

FDA approved Krazati (adagrasib) (NDA 216340)

Sponsor: BRISTOL. Class: Type 1 - New Molecular Entity.

Trial startedNov 22, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05609578

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Trial registeredNov 8, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05609578

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Trial startedAug 1, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05375994

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

Trial registeredJul 25, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05472623

Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Trial registeredMay 17, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05375994

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

2021

Trial registeredDec 17, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05162443

Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

2020

Trial startedDec 2, 2020· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients Wit

Trial registeredNov 3, 2020· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients Wit

Trial startedJun 9, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04418661

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Trial registeredJun 5, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04418661

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

2019

Trial startedOct 17, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03994796

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Trial registeredJun 21, 2019· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03994796

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.