Drug Profile

Cobimetinib - Genentech/Exelixis

Alternative Names: Cobimetinib fumarate; Cotellic; GDC-0973; RG-7421; RO 5514041; XL-518

Latest Information Update: 17 Oct 2025

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At a glance

Originator Exelixis
Developer Bristol-Myers Squibb; Exelixis; Genentech; InxMed; M. D. Anderson Cancer Center; Massachusetts General Hospital; Memorial Sloan-Kettering Cancer Center; Roche; University Hospital Tubingen
Class Antineoplastics; Azetidines; Fluorobenzenes; Iodobenzenes; Small molecules
Mechanism of Action Mitogen-activated protein kinase kinase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Malignant melanoma; Histiocytosis
New Molecular Entity Yes

Marketed Malignant melanoma
Registered Histiocytosis
Phase III Colorectal cancer
Phase II Brain metastases; Breast cancer; Head and neck cancer; Non-small cell lung cancer; Renal cell carcinoma; Triple negative breast cancer; Urogenital cancer; Vascular disorders
Phase I/II Adenocarcinoma; Multiple myeloma; Solid tumours
Phase I Uveal melanoma
No development reported Acute myeloid leukaemia; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer

03 Sep 2025 Genentech completes a phase II trial in Vascular disorders (In children, In adolescents, In adults, In elderly) in USA (PO, Suspension, Tablet) (NCT05125471)
27 Feb 2025 Roche completes a phase I/II trial in Adenocarcinoma (Combination therapy, Metastatic disease) in Spain, South Korea, Japan, Germany, USA (PO) (NCT03193190)
27 Feb 2025 Phase-I development in Solid-tumours (Combination therapy, Late-stage disease) is still ongoing in Japan (PO, Tablet) (Chugai Pharmaceutical pipeline, February 2025)

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