Drugs / Sotorasib
Sotorasib
also known as
AMG 510 · (S)-AMG-510 · CT-AMG510AMG-510AMG510 · KRAS G12C INHIBITOR 9 · KRAS MUTANT-TARGETING AMG 510 · LUMAKRAS · LUMYKRAS · SOTORASIB (AMG510) RACEMATE
Small molecule targets KRAS via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LUMAKRAS | — | 2025-01-16 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Lumykras | — | 2022-01-06 | europa.eu ↗ |
| Approved | US (FDA) | LUMAKRAS | — | 2021-05-28 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 2021
EU approved 2022
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201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 128 trials | ||||||
| Phase 1 | NCT06892054 | Aug 2025 → Aug 2030 expected | pancreatic adenocarcinoma | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Recruiting | No outcome recorded |
| Phase 1 | NCT06804824 | Feb 2025 → Aug 2027 expected | cancer | Vividion Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06807619 | Jan 2025 → Jan 2028 expected | brain neoplasm | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06333951 | Sep 2024 → Oct 2026 expected | non-small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06061523 | Jul → Sep 2024 | — | Amgen | Withdrawn | No outcome recorded |
| Phase 1 | NCT06249282 | Apr 2024 → Nov 2026 expected | non-small cell lung carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06127940 | Oct 2023 → Jun 2025 | non-small cell lung carcinoma | Karolinska University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05815173 | Aug 2023 → Aug 2027 expected | respiratory system cancer | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 1 | NCT05374538 | Nov 2022 → Aug 2023 | non-small cell lung carcinoma | Vitrac Therapeutics, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT05497557 | Jul → Sep 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05480865 | Jul 2022 → Aug 2024 | metastatic malignant neoplasm, non-small cell lung carcinoma | Navire Pharma Inc., a BridgeBio company | Terminated | No outcome recorded |
| Phase 1 | NCT05327491 | Mar → Jul 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04959981 | Sep 2021 → Apr 2023 | non-small cell lung carcinoma | Erasca, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05045638 | Aug → Oct 2021 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05048784 | Aug 2021 → Feb 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04892017 | Jun 2021 → Mar 2026 | metastatic neoplasm, non-small cell lung carcinoma | Deciphera Pharmaceuticals, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04887064 | Apr 2021 → Mar 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05599828 | Jul → Sep 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04380753 | Apr 2020 → Dec 2021 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05578859 | Mar 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05571163 | Mar → Jun 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05581992 | Jan 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05568082 | Dec 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05581758 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05550129 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05577624 | Nov → Dec 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05598281 | Nov 2019 | — | Amgen | Completed | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07012031 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05251038 | Sep 2022 → Jan 2023 | malignant pancreatic neoplasm | Devalingam Mahalingam | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05180422 | Jun 2022 → Jan 2023 | non-small cell lung carcinoma | Criterium, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05074810 | Apr 2022 → Jun 2026 overdue | non-small cell lung carcinoma | Verastem, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05313009 | Mar 2022 → Jul 2023 | non-small cell lung carcinoma | Medical University of South Carolina | Terminated | No outcome recorded |
| Phase 1/2 | NCT04720976 | Mar 2021 → Dec 2023 | non-small cell lung carcinoma | Allist Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04092673 | Oct 2019 → Dec 2024 | cancer | Effector Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT03600883 | Aug 2018 → May 2026 | — | Amgen | Completed | No outcome recorded |
| Phase 220 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 | NCT07172919 | Jan 2026 → Jan 2028 expected | — | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT07124884 | Aug 2025 → Jun 2030 expected | acute myeloid leukemia, KRAS gene mutation, colorectal carcinoma | Federation Francophone de Cancerologie Digestive | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06068153 | Mar 2025 → Sep 2026 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Withdrawn | No outcome recorded |
| Phase 2 | NCT06582771 | Aug 2024 → Aug 2026 overdue | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05638295 | Aug 2024 → Dec 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05815186 | Apr 2024 → Apr 2025 | respiratory system cancer | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT06333678 | Mar 2024 → Jan 2026 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT05993455 | Jul → Sep 2023 | — | Korea University Anam Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2026 overdue | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05631249 | Dec 2022 → Dec 2027 expected | acute myeloid leukemia, KRAS gene mutation, non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT05451056 | Aug 2022 → Jan 2026 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05400577 | Jul 2022 → Jan 2024 | non-small cell lung carcinoma | Fox Chase Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05311709 | May 2022 → Oct 2024 | non-small cell lung carcinoma | Vestre Viken Hospital Trust | Unknown | No outcome recorded |
| Phase 2 | NCT05118854 | Mar 2022 → Oct 2027 expected | lung cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05398094 | Mar 2022 → Dec 2027 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 2 | NCT04933695 | Jan 2022 → May 2025 | non-small cell lung carcinoma | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT05054725 | Dec 2021 → Jul 2024 | non-small cell lung carcinoma | Revolution Medicines, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04625647 | Apr 2021 → Dec 2026 expected | lung adenocarcinoma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06252649 | Jul 2024 → Sep 2028 expected | colorectal cancer | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05920356 | Nov 2023 → Jun 2027 expected | non-small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05198934 | Apr 2022 → Jul 2025 | colorectal cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04303780 | Jun 2020 → Aug 2022 overdue | — | Amgen | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06314763 | Nov 2023 → Mar 2024 | — | Radboud University Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04667234 | — | non-small cell lung carcinoma | Amgen | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 4 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 11 trial | ||||||
| Phase 1 | NCT05036291 Background | Oct 2021 → Sep 2025 | cancer or benign tumor | Ningbo Newbay Technology Development Co., Ltd | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07563738 Background | Mar 2026 → Sep 2029 expected | malignant pancreatic neoplasm, mesothelioma, non-small cell lung carcinoma | Orion Corporation, Orion Pharma | Recruiting | 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 31 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-17 | Amgen | FDA APPROVES LUMAKRAS® (SOTORASIB) IN COMBINATION WITH VECTIBIX® (PANITUMUMAB) FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗ |
| 2023-12-26 | Amgen | AMGEN PROVIDES REGULATORY UPDATE ON STATUS OF LUMAKRAS® (SOTORASIB) amgen.com ↗ |
| 2023-10-22 | Amgen | AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS VECTIBIX® (PANITUMUMAB) DATA IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗ |
| 2023-09-10 | Amgen | AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC amgen.com ↗ |
| 2023-08-21 | Amgen | AMGEN TO DISCUSS APPLICATION FOR LUMAKRAS® (SOTORASIB) FOR THE TREATMENT OF KRAS G12C-POSITIVE NSCLC AT FDA ADVISORY COMMITTEE MEETING amgen.com ↗ |
| 2023-06-04 | Amgen | AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) CODEBREAK 200 CNS DATA AT ASCO 2023 amgen.com ↗ |
| 2022-09-12 | Amgen | LUMAKRAS® (SOTORASIB) COMBINED WITH VECTIBIX® (PANITUMUMAB) SHOWS CONFIRMED 30% OBJECTIVE RESPONSE RATE IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER amgen.com ↗ |
| 2022-09-11 | Amgen | LUMAKRAS®/LUMYKRAS® (SOTORASIB) DEMONSTRATES SUPERIOR PROGRESSION-FREE SURVIVAL OVER DOCETAXEL IN FIRST POSITIVE PHASE 3 TRIAL OF A KRAS G12C INHIBITOR IN NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2022-08-30 | Amgen | AMGEN ANNOUNCES TOPLINE DATA FROM LUMAKRAS® (SOTORASIB) PHASE 3 TRIAL IN NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2022-04-10 | Amgen | LUMAKRAS® (SOTORASIB) CODEBREAK 100 STUDY SHOWS TWO-YEAR OVERALL SURVIVAL OF 32.5% IN PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2022-03-08 | Amgen | AMGEN TO PRESENT LONG-TERM OUTCOMES FOR LUMAKRAS® (SOTORASIB) IN KRAS G12C-MUTATED NSCLC AT AACR 2022 amgen.com ↗ |
| 2022-02-14 | Amgen | LUMAKRAS® (SOTORASIB) SHOWS ENCOURAGING AND CLINICALLY MEANINGFUL ANTICANCER ACTIVITY IN PATIENTS WITH KRAS G12C-MUTATED ADVANCED PANCREATIC CANCER IN CODEBREAK 100 TRIAL amgen.com ↗ |
| 2022-01-20 | Amgen | LUMAKRAS® (SOTORASIB) RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2022-01-10 | Amgen | EUROPEAN COMMISSION APPROVES LUMYKRAS® (SOTORASIB) FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER amgen.com ↗ |
| 2021-11-12 | Amgen | LUMYKRAS® (sotorasib) Receives Positive Opinion From EMA CHMP For Patients With KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer amgen.com ↗ |
| 2021-10-07 | Amgen | Amgen Announces New LUMAKRAS™ (sotorasib) Combination Data From Phase 1b CodeBreaK 101 Study In Patients With KRAS G12C-mutated Cancers At AACR-NCI-EORTC 2021 amgen.com ↗ |
| 2021-09-16 | Amgen | LUMAKRAS™ (Sotorasib) Combined With Vectibix® (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer amgen.com ↗ |
| 2021-06-04 | Amgen | Results From Phase 2 CodeBreaK 100 Show LUMAKRAS™ (sotorasib) Is The First And Only KRAS G12C Inhibitor With Overall Survival Data amgen.com ↗ |
| 2021-05-28 | Amgen | FDA Approves LUMAKRAS™ (Sotorasib), The First And Only Targeted Treatment For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer amgen.com ↗ |
| 2021-04-28 | Amgen | Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study amgen.com ↗ |
| 2021-02-16 | Amgen | FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer amgen.com ↗ |
| 2021-01-29 | Amgen | Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China amgen.com ↗ |
| 2021-01-28 | Amgen | Amgen's Investigational KRAS G12C Inhibitor Sotorasib Demonstrated Rapid, Deep And Durable Responses In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer amgen.com ↗ |
| 2020-12-22 | Amgen | Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency amgen.com ↗ |
| 2020-12-16 | Amgen | Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation amgen.com ↗ |
| 2020-12-08 | Amgen | Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation amgen.com ↗ |
| 2020-10-05 | Amgen | Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer amgen.com ↗ |
| 2020-09-20 | Amgen | Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine amgen.com ↗ |
| 2020-05-29 | Amgen | Amgen Presents New AMG 510 Clinical Data Across Multiple Solid Tumors During ASCO20 Virtual Scientific Program amgen.com ↗ |
| 2019-10-30 | Amgen | The Discovery Of Amgen's Novel Investigational KRAS(G12C) Inhibitor AMG 510 Published In Nature amgen.com ↗ |
| 2019-06-03 | Amgen | Amgen Announces First Clinical Data Evaluating Novel Investigational KRASG12C Inhibitor AMG 510 At ASCO 2019 amgen.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sotorasib | “To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS...” NCT05118854 ↗53“Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).” NCT04303780 ↗ “Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA” NCT05036291 ↗ “Sotorasib is administered as an 8-week-introduction treatment” NCT06127940 ↗ |
| Known as | (S)-AMG-510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | AMG 510 | “To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS...” NCT05118854 ↗16“AMG510 (Sotorasib) is small molecule that specifically and irreversibly inhibits the KRAS-G12C mutant protein.” NCT05398094 ↗ “Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation” NCT03600883 ↗ “AMG510/Sotorasib was the first KRAS G12C inhibitor to the enter the clinic.” NCT05313009 ↗ |
| Known as | CT-AMG510AMG-510AMG510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | KRAS G12C INHIBITOR 9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | KRAS MUTANT-TARGETING AMG 510 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | LUMAKRAS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | LUMYKRAS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Known as | SOTORASIB (AMG510) RACEMATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4535757 ↗ |
| Action | Inhibit | “a highly potent, selective, and well-tolerated KRASG12C inhibitor” PMID 31820981 ↗ Dec 2019 |
| Modality | Small molecule | “identification of a novel quinazolinone scaffold” PMID 31820981 ↗ Dec 2019 |
| Route | Oral | “following administration as an oral Tablet formulation” NCT03600883 ↗ |
| Target | KRAS | “a highly potent, selective, and well-tolerated KRASG12C inhibitor” PMID 31820981 ↗ Dec 2019 |