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sotorasib

Trade name: LUMAKRAS

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

May 28, 2021

Clinical trial activity

58 trials · 53 clinical orgs · 1 marketing orgs

Phase 1
31
Phase 2
31
Phase 3
5
Phase 4
1

Earliest trial started Aug 27, 2018 (NCT03600883)

Timeline

2010s

  1. Jan 1, 2018

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. May 1, 2019

    Orphan Drug Designation

2020s

  1. Jan 1, 2020

    Amgen — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2021

    Earliest Phase 2 Sponsor(trial)

  3. May 28, 2021

    Amgen — Earliest FDA Approval

  4. May 28, 2021

    Amgen — Marketing Organization

  5. May 28, 2021

    Amgen — NDA Secondary Org

  6. May 28, 2021

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughMay 28, 2021

Chemistry & pharmacology

Loading structure…

SMILES

C=CC(=O)N1CCN(c2nc(=O)n(-c3c(C)ccnc3C(C)C)c3nc(-c4c(O)cccc4F)c(F)cc23)[C@@H](C)C1
Mol. weight
560.61 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07012031Phase 1/Phase 2 (Phase 2)Aug 7, 2026National Cancer Institute (NCI), University of Toronto
NCT07172919Phase 2Oct 20, 2025Amgen
NCT07124884Phase 2Aug 31, 2025Arbeitsgemeinschaft fur Internistische Onkologie (AIO), Federation Francophone de Cancerologie Digestive, Northwest Oncology Cooperative Group, Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
NCT06892054Phase 2Jun 30, 2025Apices Soluciones S.L., Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR), Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
NCT06804824Phase 1Feb 25, 2025Vividion Therapeutics
NCT06807619Phase 1Jan 29, 2025Amgen, Memorial Sloan-Kettering Cancer Center
NCT06497556Phase 3Sep 23, 2024Chugai, Roche
NCT06333951Phase 1Sep 17, 2024Amgen
NCT06582771Phase 2Aug 30, 2024Memorial Sloan-Kettering Cancer Center
NCT06252649Phase 3Jul 17, 2024Amgen
NCT05815186Phase 2Apr 30, 2024New York University
NCT06249282Phase 1Apr 24, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06061523Phase 1Apr 15, 2024Amgen
NCT06068153Phase 2Mar 31, 2024Amgen, Eisai, ETOP IBCSG Partners Foundation, Royal Marsden Hospital NHS Trust
NCT06333678Phase 2Mar 20, 2024Amgen, Memorial Sloan-Kettering Cancer Center
NCT05920356Phase 3Nov 16, 2023Amgen
NCT06314763Phase 4Nov 9, 2023Amgen, Radboud University
NCT05815173Phase 1Aug 1, 2023New York University
NCT05993455Phase 2Jul 3, 2023Korea University
NCT05845450Phase 2May 11, 2023Gruppo Oncologico del Nord-Ovest, University of Milan
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (53)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit362652018
National Cancer Institute (NCI)Government5322021
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital3322024
ECOG-ACRIN Cancer Research GroupAcademic/Hospital2012022
New York UniversityAcademic/Hospital2222023
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)Academic/Hospital2112025
Aarhus UniversityAcademic/Hospital1012022
Apices Soluciones S.L.For profit1012025
Arbeitsgemeinschaft fur Internistische Onkologie (AIO)Academic/Hospital1012025
ChugaiFor profit1012024
City of Hope National Medical CenterAcademic/Hospital1112024
Criterium, Inc.For profit1112022
EisaiFor profit1012024
Erasca, Inc.For profit1112021
ETOP IBCSG Partners FoundationAcademic/Hospital1112024
Federation Francophone de Cancerologie DigestiveAcademic/Hospital1112025
Fundación GECPAcademic/Hospital1112022
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)Academic/Hospital1012025
Gruppo Oncologico del Nord-OvestAcademic/Hospital1112023
Hoosier Cancer Research NetworkAcademic/Hospital1112022
53 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGMay 28, 2021
AmgenFor profitNDA2May 28, 2021
AmgenFor profitNDAMay 28, 2021