LUMAKRAS

Peak

sotorasib

NDAORALTABLETPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
31

Mechanism of Action

G12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS. Sotorasib blocked KRAS…

Clinical Trials (5)

NCT07172919Phase 2Recruiting

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

Started Jan 2026
14 enrolled
Advanced Solid Tumors
NCT07143513N/ARecruiting

Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients

Started Aug 2025
115 enrolled
Non-Small Cell Lung Cancer
NCT06068153Phase 2Withdrawn

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Started Mar 2025
0
Metastatic Non Small Cell Lung CancerKRAS G12C
NCT06807619Phase 1Recruiting

A Study of Sotorasib in People With Brain Tumors

Started Jan 2025
16 enrolled
Brain Tumor
NCT06659341Phase 1Recruiting

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

Started Nov 2024
104 enrolled
Advanced Solid Tumors Harboring KRAS G12C Mutation

Loss of Exclusivity

LOE Date
Sep 15, 2040
176 months away
Patent Expiry
Sep 15, 2040
Exclusivity Expiry
Jan 16, 2032

Patent Records (5)

Patent #ExpiryTypeUse Code
10519146
May 21, 2038
SubstanceProduct
12280056
Nov 18, 2039
U-4107
11236091
May 20, 2040
SubstanceProduct
U-3306
11827635
May 20, 2040
SubstanceProduct
U-3306
12398133
May 20, 2040
SubstanceProduct
U-3306