Drugs / Adagrasib
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 1 milestone | |||||
| Filed | US (FDA) | KRAZATI | colorectal cancer | 2024-02-20 | “U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI ® (adagrasib)” bms.com ↗ “the FDA has accepted its sNDA for adagrasib in combination with cetuximab” zailaboratory.com ↗ |
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2022-03-01 | “The FDA accepted the adagrasib NDA for the treatment of patients with NSCLC harboring the KRAS G12C mutation” zailaboratory.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | KRAZATI | — | 2024-06-21 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Krazati | — | 2024-01-05 | europa.eu ↗ |
| Approved | US (FDA) | KRAZATI | — | 2022-12-12 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07723118 | Aug → Sep 2026 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT07382726 | Jul 2026 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06764771 | Mar 2025 → Oct 2027 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1 | NCT06130254 | Jan → Jun 2024 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT06039384 | Dec 2023 → Apr 2025 | cancer | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05722327 | Dec 2023 → Sep 2027 expected | colon carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05840510 | Aug 2023 → Dec 2024 | metastatic malignant neoplasm, non-small cell lung carcinoma | Mirati Therapeutics Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05868356 | Jun → Jul 2023 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05634525 | May 2023 → Jul 2025 | malignant pancreatic neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05848843 | Apr 2023 → Jan 2024 | digestive system cancer, lung cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05578092 | Dec 2022 → Feb 2026 | colorectal cancer, non-small cell lung carcinoma | Mirati Therapeutics Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05263986 | May 2022 → Oct 2023 | — | Zai Lab (Shanghai) Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05178888 | Jan 2022 → Jun 2023 | cancer or benign tumor | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04975256 | Jul 2021 → Nov 2022 | cancer of unknown primary site, lung cancer, malignant colon neoplasm, metastatic malignant neoplasm | Mirati Therapeutics Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04330664 | Apr 2020 → Jul 2022 | cancer of unknown primary site, metastatic malignant neoplasm | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06412198 | Aug 2024 → Mar 2029 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05375994 | Aug 2022 → Jun 2026 | metastatic malignant neoplasm, non-small cell lung carcinoma | Verastem, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04418661 | Jun 2020 → Apr 2024 | metastatic neoplasm | Sanofi | Terminated | No outcome recorded |
| Phase 1/2 | NCT03785249 | Jan 2019 → Dec 2026 expected | metastatic malignant neoplasm | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07543172 | Oct 2026 → Jun 2029 expected | non-small cell lung carcinoma | Roswell Park Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07415031 | May 2026 → Feb 2028 expected | cancer | Mirati Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07288034 | Apr 2026 → Oct 2028 expected | non-small cell lung carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06248606 | Aug 2024 → Feb 2027 expected | non-small cell lung carcinoma | Ryan Gentzler, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05853575 | Feb 2024 → Jul 2026 overdue | lung cancer, metastatic malignant neoplasm | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05673187 | Jun 2023 → Jul 2025 overdue | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05609578 | Nov 2022 → Sep 2026 overdue | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03994796 | Oct 2019 → Nov 2025 overdue | NTRK fusion positive cancer, metastatic malignant neoplasm in the brain | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04613596 | Dec 2020 → Oct 2028 expected | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06875310 | Apr 2025 → Sep 2029 expected | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04793958 | Jun 2021 → Jan 2026 overdue | colorectal cancer | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04685135 | Feb 2021 → Dec 2023 overdue | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05162443 | — | metastatic malignant neoplasm | Bristol-Myers Squibb | Approved for marketing | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06026410 Background | Oct 2023 → Jan 2027 expected | clear cell renal carcinoma, colorectal cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma | Kura Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05924152 Comparator | Jun → Aug 2023 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT06024174 Background | Nov 2023 → May 2024 | cancer | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05472623 Comparator | Mar 2023 → Jun 2025 | non-small cell lung carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06497556 Comparator | Sep 2024 → May 2026 overdue | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-07-01 | Genentech, Inc. | Results Genentech’s Divarasib Shows Superiority in Head-To-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today positive results from the Phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). |
| 2026-07-01 | Genentech, Inc. | Results Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer gene.com ↗
The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). |
| 2026-06-03 | Kura Oncology, Inc. | Results Kura Oncology Highlights Darlifarnib’s Potential as a Foundational Combination Platform for KRAS-Mutant Cancers and Outlines Development Strategy kuraoncology.com ↗
Preliminary Phase 1a data from darlifarnib + adagrasib demonstrate confirmed, objective response rates of 67% in pancreatic cancer, 50% in non-small cell lung cancer, and 29% in KRAS inhibitor-naïve colorectal cancer patients |
| 2026-05-26 | Kura Oncology, Inc. | Results Kura Oncology Reports Strong Clinical Activity and Safety with Darlifarnib + Adagrasib in KRAS G12C-Mutated Solid Tumors kuraoncology.com ↗
The combination of darlifarnib plus adagrasib demonstrated meaningful antitumor activity in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) patients with prior KRAS inhibitor (KRASi) exposure, as well as KRASi-naïve colorectal cancer (CRC) patients. |
| 2024-06-21 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of KRAZATI® (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC) bms.com ↗
The FDA approval of KRAZATI combined with cetuximab now provides a new treatment option to these patients when their tumors do not respond well to prior therapies. |
| 2024-06-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Multiple New Analyses at 2024 ASCO® Annual Meeting Highlighting Opdivo and Opdivo-based Combinations in Early and Advanced Stages of Non-Small Cell Lung Cancer bms.com ↗
Additionally, data from the Phase 3 KRYSTAL-12 study of KRAZATI ® (adagrasib) showed a statistically significant improvement in progression-free survival (PFS) compared to docetaxel in patients with previously treated KRAS G12C -mutated NSCLC. |
| 2024-06-01 | Bristol-Myers Squibb | Results KRAZATI (adagrasib) Demonstrated Statistically Significant Improvement in Progression-Free Survival in Patients with Pretreated Locally Advanced or Metastatic KRASG12C-Mutated Non-Small Cell Lung Cancer bms.com ↗
At a median follow-up of 9.4 months, KRAZATI demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint, as assessed by Blinded Independent Central Review (BICR) compared to docetaxel (HR: 0.58; [95% CI, 0.45-0.76]; P <0.0001). |
| 2024-04-08 | Bristol-Myers Squibb | Results KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC) bms.com ↗
Disease control was observed in 85% of patients. |
| 2024-04-01 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer zailaboratory.com ↗
Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. |
| 2024-03-28 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung … bms.com ↗
Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. |
| 2024-02-20 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or... bms.com ↗
U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI ® (adagrasib) in Combination with Cetuximab |
| 2023-09-28 | Kura Oncology, Inc. | Results Kura Oncology Reports Preclinical Data Showing Ability of KO-2806 to Enhance Antitumor Activity of KRASᴳ¹²ᶜ Inhibitors in Non-Small Cell Lung Cancer kuraoncology.com ↗ |
| 2023-04-17 | Kura Oncology, Inc. | Results Kura Oncology Reports Preclinical Data Highlighting Synergistic Activity of Farnesyl Transferase Inhibitor in Combination with Targeted Therapies kuraoncology.com ↗
today reported preclinical data supporting the potential use of farnesyl transferase inhibitors (FTIs) to treat various types of solid tumors in combination with targeted therapies, including KRAS G12C inhibitors and anti-angiogenic tyrosine kinase inhibitors (TKIs). |
| 2022-12-05 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner Mirati Therapeutics Presents Late-Breaking Results Evaluating Concurrent Adagrasib and Pembrolizumab in First-Line Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) zailaboratory.com ↗
Adagrasib in combination with pembrolizumab demonstrates favorable tolerability and promising preliminary efficacy in patients with first-line advanced/metastatic NSCLC harboring a KRAS G12C mutation |
| 2021-08-08 | Syntrix Biosystems, Inc. | Results New Study Points to SX-682 as Novel Strategy to Broadly Increase the Effectiveness of Therapies Targeting the RAS/RAF/MEK/ERK Signaling Pathway in Non-Small Cell Lung Cancer syntrixbio.com ↗
The researchers found the same effects on CXCR2 signaling and gMDSC influx in tumors from patients treated with the KRAS G12C-specific inhibitor, adagrasib. |
All press releases naming this drug 19 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | adagrasib | “This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with...” NCT04975256 ↗30“Oral adagrasib 200 mg twice daily (BID) for 8 days (Days 1 to 8). Predose PK blood samples for the measurement of adagrasib concentration will be collected on Days 2 to 7.” NCT05868356 ↗ “Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer” NCT05722327 ↗ “Adagrasib (MRTX849) is an oral, highly selective, small-molecule, covalent inhibitor of KRASG12C.” PMID 35167329 ↗ Feb 2022 “Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)” NCT04613596 ↗ |
| Known as | ADAGRASIB (MRTX849) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594350 ↗ |
| Known as | COMPOUND 20 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594350 ↗ |
| Known as | KRAS G12C INHIBITOR MRTX849 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594350 ↗ |
| Known as | KRAZATI | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594350 ↗ |
| Known as | MRTX849 | “Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer” NCT05722327 ↗11“Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab” NCT05472623 ↗ “adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen” NCT05162443 ↗ |
| Action | Inhibit | “small molecule inhibitor of KRAS G12C” NCT03785249 ↗ |
| Modality | Small molecule | “MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.” NCT03785249 ↗ |
| Route | Oral | “MRTX849 will be administered orally once or twice daily in a continuous regimen” NCT03785249 ↗ |
| Target | KRAS | “small molecule inhibitor of KRAS G12C” NCT03785249 ↗ |