Drugs / Adagrasib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| 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 |
| 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 |
| 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| Phase 1 | NCT05634525 | May 2023 → Jul 2025 | malignant pancreatic neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05848843 | Apr 2023 → Jan 2024 | digestive system cancer, lung cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05578092 | Dec 2022 → Feb 2026 | colorectal cancer, non-small cell lung carcinoma | Mirati Therapeutics Inc. | Terminated | No outcome recorded |
| 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 |
| 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 | Sep 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 expected | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03994796 | Oct 2019 → Oct 2026 expected | 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 | ||||||
| Phase 3 | NCT06875310 | Apr 2025 → Sep 2029 expected | non-small cell lung carcinoma | Mirati Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04793958 | Jul 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 | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05162443 | — | metastatic malignant neoplasm | Bristol-Myers Squibb | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| 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 1/21 trial | ||||||
| Phase 1/2 | NCT06024174 Background | Nov 2023 → May 2024 | cancer | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| 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 |
| Phase 31 trial | ||||||
| Phase 3 | NCT06497556 Comparator | Sep 2024 → May 2026 overdue | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-11-07 | Incyte Corporation | Incyte And Mirati Therapeutics Enter Into Clinical Trial Collaboration and Supply Agreement to Evaluate INCB99280 and Adagrasib in Patients with KRASG12C-Mutated Solid Tumors incyte.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 39 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 ↗29“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 ↗ |