Drug · Small Molecule

Cobimetinib

CI-DRUG-00000161Explore in graph →NCIt C68923 CHEMBL2146883 CIViC Approved

Regulatory

Approvals (7)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory7 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as COTELLIC (DIN 02452340) under ATC L01EE02 COBIMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 6, 2016	health-canada-dpd
EU EMA	Melanoma	Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	approved	Nov 20, 2015	ema
US FDA	—	Efficacy supplement 2022-10-28 (see label)	approved	Oct 28, 2022	openfda
US FDA	—	Efficacy supplement 2022-07-28 (see label)

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	22	7	8	85	7	CA, EU, US	Nov 10, 2015	2007-05
Malignant Lung Neoplasm	Phase3	Phase 3	5	2	2	8	0	—	—	Jun 16, 2015
Malignant Thyroid Gland Neoplasm	Phase3	Phase 3	3	2	1	3	0	—	—	Jul 27, 2017
Multiple Myeloma	Phase3	Phase 3	1	1	1	3	0	—

Curated evidence

Clinical evidence (22)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–22 of 22 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ARAF Mutation + ARAF P216A + ARAF S225V1
Cobimetinib

Clinical trials

Trials with this intervention (87)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 87 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04302025	A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)(NAUTIKA1)	recruiting	Phase 2	99	Genentech, Inc.INDUSTRY	1	Sep 10, 2026	clinicaltrials
NCT04931342	A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Molecule

Record

Kind: Small Molecule
Mechanism: Dual specificity mitogen-activated protein kinase kinase 1 inhibitor; Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
Targets: 2 genes
UNII: 6EXI96H8SV
Aliases: Cobimetinib, Cobimetinib Fumarate, Cotellic, COTELLIC, Gdc 0623, GDC 0973, GDC-0973, GDC0973, MEK Inhibitor GDC-0973, RG 7420, RG7420, XL 518, XL518

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (5)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EE02	COBIMETINIB
ATC (WHO)	L01XE38	Antineoplastic agents
DIN (Health Canada)

BRAF Non-V6002
Cobimetinib	Erdheim-Chester Disease	Predictive	B	Supports Sensitivity Response	4	submitted	EID11298 In an open-label, phase II trial, 18 patients with histiocytosis, including 12 patients with Erdheim-Chester disease with one patient having a non-V600 BRAF mutation, of any mutational status were enr… (full text at CIViC) PMID 30867592 · Diamond et al., 2019 · Open in CIViC	civic
〃	Langerhans Cell Histiocytosis	Predictive	B	Supports Sensitivity Response	4	submitted	EID11299 In an open-label, phase II trial, 18 patients with histiocytosis, including two patients with Langerhans cell histiocytosis, with one patient having a non-V600 BRAF mutation, of any mutational status … (full text at CIViC) PMID 30867592 · Diamond et al., 2019 · Open in CIViC	civic

BRAF Non-V6002

Cobimetinib

Erdheim-Chester Disease

Predictive

Supports Sensitivity Response

submitted

EID11298

In an open-label, phase II trial, 18 patients with histiocytosis, including 12 patients with Erdheim-Chester disease with one patient having a non-V600 BRAF mutation, of any mutational status were enr… (full text at CIViC)

PMID 30867592 · Diamond et al., 2019 · Open in CIViC

BRAF V600E4
Cobimetinib + VemurafenibCombination	Ganglioglioma	Predictive	C	Supports Sensitivity Response	1	submitted	EID11310 In this case study, a 32-year-old man, previously fit and well, presented with a two-month history of vertigo, right visual disturbance, dysphagia, and ataxia. Brain MRI revealed a large mixed solid a… (full text at CIViC) PMID 31985841 · Yau et al., 2020 · Open in CIViC	civic
Cobimetinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1141 Preclinical study analyzing the differential response to MEK inhibitors in KRAS and BRAF mutant cancer cell lines and mouse xenografts. Inhibition of active, phosphorylated MEK by GDC-0973 (cobimetini… (full text at CIViC) PMID 23934108 · Hatzivassiliou et al., 2013 · Open in CIViC	civic
Atezolizumab + Cobimetinib + VemurafenibCombination	Melanoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID13045 In an exploratory biomarker analysis of the randomized, double-blind, placebo-controlled phase III IMspire150 trial (NCT02908672), 379 patients with centrally confirmed BRAF V600E-mutated, previously … (full text at CIViC) PMID 35131452 · Robert et al., 2022 · Open in CIViC	civic
Cobimetinib + VemurafenibCombination	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID1421 In this Phase III trial (coBRIM, NCT01689519) of 495 V600 mutant melanoma patients, 344 had V600E mutation. 174 patients were treated with vemurafenib and placebo, and 170 were treated with vemurafeni… (full text at CIViC) PMID 25265494 · Larkin et al., 2014 · Open in CIViC	civic