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Krazati

(Adagrasib)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Adagrasib is used to treat a specific type of lung cancer (non-small cell lung cancer) in patients whose cancer cells have a particular genetic mutation called KRAS G12C. It works by blocking the growth signal that allows these cancer cells to multiply.[2] Krazati is currently approved and in use across 16 indications[4].[1]

Krazati is one of 361 small molecule programs targeting Colorectal Cancer. It is currently in Approved.

16

Indications

27

Total Trials

17

Active Trials

360

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

5

Patents

Pipeline

Status by Indication[4][1]

Indication

Colorectal CancerApproved

Metastatic Malignant NeoplasmActive, not recruiting

Non-Small Cell Lung CarcinomaActive, not recruiting

Malignant Pancreatic NeoplasmApproved

NSCLC Stage IVActive, not recruiting

Carcinoma, Non-Small-Cell LungRecruiting

Solid TumorRecruiting

Advanced Malignant TumorsRecruiting

Advanced Non-Small Cell Lung CancerRecruiting

Advanced Lung Non-Small Cell CarcinomaNot yet recruiting

Colorectal CancerApproved

Approved

Metastatic Malignant NeoplasmApproved

Active, not recruiting

Non-Small Cell Lung CarcinomaApproved

Active, not recruiting

Malignant Pancreatic NeoplasmApproved

Approved

NSCLC Stage IVPhase 2

Active, not recruiting

Carcinoma, Non-Small-Cell LungPhase 3

Recruiting

Solid TumorPhase 2

Recruiting

Advanced Malignant TumorsPhase 1

Recruiting

Advanced Non-Small Cell Lung CancerPreclinical

Recruiting

Advanced Lung Non-Small Cell CarcinomaPhase 2

Not yet recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Krazati

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Cytoxan

BBaxter Healthcare Corporation

Concurrent Lenvatinib

TTrans Tasman Radiation Oncology Group

Carboplatin or Cisplatin

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Valemetostat Tosylate

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Cancer

NCT05853575

Phase 2Active, not recruiting

NSCLC Stage IV

NCT05673187

Phase 2Active, not recruiting

Advanced NSCLC

NCT05609578

Q2 2027

Phase 1Recruiting

Advanced Solid Tumors

NCT06026410

Q4 2027

Phase 1Recruiting

Advanced Malignant Tumors

NCT06764771

Q1 2028

Phase 2Recruiting

Solid Tumor

NCT07415031

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer6 trials

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)

Terminated·MMirati Therapeutics Inc.·Phase 1·NCT05840510·6 enrolled

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial

Not yet recruiting·—·Phase 2·NCT07288034·535 enrolled

A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05848843

Show 3 more trials

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06130254·52 enrolled

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06497556·338 enrolled

Combination Of Izalontamab Brengitecan And Adagrasib In Advanced KRAS G12Ci-Refractory Non-Small Cell Lung Cancer - The IZA-A Trial

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07382726·18 enrolled

Metastatic Colorectal Cancer2 trials

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07318389·100 enrolled

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

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06412198·31 enrolled

Brain Metastases2 trials

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

Recruiting·—·Phase 2·NCT06248606·30 enrolled

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Suspended·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03994796·186 enrolled

Solid Tumor2 trials

A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Terminated· Incyte logo

Incyte·Phase 1·NCT06039384·6 enrolled

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

Recruiting·MMirati Therapeutics Inc.·Phase 2·NCT07415031·170 enrolled

Drug1 trial

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Completed·MMirati Therapeutics Inc.·Phase 1·NCT06801418·160 enrolled

14 more indications

Solid Tumors1 trial

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT06024174·5 enrolled

Interaction1 trial

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

Completed·MMirati Therapeutics Inc.·Phase 1·NCT05924152·16 enrolled

Advanced Malignancies1 trial

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

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT04418661·65 enrolled

Advanced Solid Tumors1 trial

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06026410·300 enrolled

Neoadjuvant1 trial

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

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05472623

Patients With Advanced Solid Tumors1 trial

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

Approved for marketing· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05162443

Advanced Non-Small Cell Lung Cancer1 trial

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Recruiting·MMirati Therapeutics Inc.·Preclinical·NCT04613596·626 enrolled

NSCLC Stage IV1 trial

A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status

Active, not recruiting·EETOP IBCSG Partners Foundation·Phase 2·NCT05673187·68 enrolled

Advanced Lung Non-Small Cell Carcinoma1 trial

Phase II Study of CIMAVAX-EGF in Combination With KRAS G12C Inhibitors as Treatment for Advanced Stage KRAS G12C Mutated NSCLC

Not yet recruiting·RRoswell Park Cancer Institute·Phase 2·NCT07543172·29 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Recruiting·MMirati Therapeutics Inc.·Phase 3·NCT06875310·630 enrolled

Advanced Cancer1 trial

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Active, not recruiting·MMirati Therapeutics Inc.·Phase 2·NCT05853575·200 enrolled

Advanced Malignant Tumors1 trial

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06764771·437 enrolled

Advanced NSCLC1 trial

A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Active, not recruiting·MMirati Therapeutics Inc.·Phase 2·NCT05609578·90 enrolled

Unspecified1 trial

A Phase 1, Single-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent

Recruiting·MMirati Therapeutics Inc.·Phase 1·NCT07723118·10 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 12, 2022

KRAZATI

NDA NDA216340

Dec 12, 2022

KRAZATI

NDA NDA216340

Jun 21, 2024

KRAZATI

NDA NDA216340

Mar 25, 2026

KRAZATI

NDA NDA216340

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Adagrasib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Krazati drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Adagrasib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Adagrasib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216340). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Krazati. U.S. Food & Drug Administration.
[7]
PubMed — 2 publications indexed for Adagrasib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: KRAS G12C Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Patent Landscape[6]

Patent Cliff

May 17, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10689377May 17, 2037

12336995Feb 5, 2041

12281113Sep 10, 2041

12653789Aug 20, 2043

12383503Aug 21, 2043

Key Publications[7]

Adagrasib Plus Cetuximab in KRAS G12C Colorectal Cancer

N Engl J MedFeb 16, 2023DOI: 10.1056/NEJMoa2212419

Adagrasib in KRAS G12C-Mutated Non-Small Cell Lung Cancer: KRYSTAL-1

N Engl J MedDec 8, 2022DOI: 10.1056/NEJMoa2204619

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