Drugs / Divarasib
last change 11 days ago re-read 8 days ago

Divarasib

also known as GDC-6036 · RG-6330 · RO-7435846

Small molecule targets KRAS via inhibition

Developed for
non-small cell lung carcinoma · cancer · colorectal cancer
Investigated by
Hoffmann-La Roche · Genentech, Inc. · Chugai Pharmaceutical

Trials 14

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT06835465 Feb → May 2025 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT06734208 Jan → Nov 2025 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT06690138 Nov 2024 → Feb 2025 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT06677957 Nov → Dec 2024 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT04929223 Oct 2021 → Aug 2030 expected colorectal cancer Hoffmann-La Roche Recruiting No outcome recorded
Phase 1 NCT04449874 Jul 2020 → Dec 2027 expected colorectal cancer, non-small cell lung carcinoma Genentech, Inc. Active not recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05789082 Jun 2023 → Jan 2032 expected non-small cell lung carcinoma Hoffmann-La Roche Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT04589845 Jan 2021 → Sep 2032 expected cancer Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 2 NCT04302025 Nov 2020 → Nov 2026 expected non-small cell lung carcinoma Genentech, Inc. Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03178552 Sep 2017 → Jun 2027 expected non-small cell lung carcinoma Hoffmann-La Roche Active not recruiting Mixed
Phase 34 trials · 1 met primary
Phase 3 NCT07541170 Sep 2026 → Jan 2032 expected non-small cell lung carcinoma Hoffmann-La Roche Recruiting No outcome recorded
Phase 3 NCT06793215 Oct 2025 → Nov 2028 expected non-small cell lung carcinoma Hoffmann-La Roche Recruiting No outcome recorded
Phase 3 NCT06497556 Sep 2024 → May 2026 overdue non-small cell lung carcinoma Hoffmann-La Roche Active not recruiting Met primary
Phase 3 NCT05862285 Jun 2023 → Mar 2033 expected cancer Hoffmann-La Roche Recruiting No outcome recorded
Comparator or background therapy1 trial
— NCT07783009 Background — non-small cell lung carcinoma Genentech, Inc. Available No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-07-02 Hoffmann-La Roche Results [Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer roche.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).
2026-07-02 Chugai Pharmaceutical Results Roche’s Announcement Regarding divarasib (Announcement of Phase III Krascendo1 Study Results) chugai-pharm.co.jp ↗
Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer
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).

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as divarasib “Divarasib (GDC-6036) is a covalent KRAS G12C inhibitor that was designed to have high potency and selectivity.” PMID 37611121 ↗ Aug 2023
14

NCT07783009 ↗

NCT03178552 ↗

NCT04589845 ↗

NCT06793215 ↗

NCT07541170 ↗

NCT06835465 ↗

NCT06734208 ↗

NCT06677957 ↗

NCT05789082 ↗

NCT04302025 ↗

Show 4 more sources

Known as GDC-6036 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04449874 ↗
Known as RG-6330 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095236 ↗
Known as RO-7435846 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095236 ↗
Action Inhibit “Divarasib (GDC-6036) is a covalent KRAS G12C inhibitor that was designed to have high potency and selectivity.” PMID 37611121 ↗ Aug 2023
Modality Small molecule — CHEMBL5095236 ↗
Route Oral “divarasib PO QD” NCT03178552 ↗
Target KRAS “Divarasib (GDC-6036) is a covalent KRAS G12C inhibitor that was designed to have high potency and selectivity.” PMID 37611121 ↗ Aug 2023