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Drug

Cobimetinib

Established medicine
ClassDual specificity mitogen-activated protein kinase kinase 1 inhibitorResearchOngoing clinical research

Also known as Cotellic.

RxNorm1722365ChEMBLCHEMBL2146883ATCL01EE02UNIIER29L26N1X
25
Active clinical trials
2
Protein targets
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: COBIMETINIB (NDA206192)

Regulatory2026-08-20FDA

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Clinical trial2026-08-11Results expected Q4 2026 · ClinicalTrials.gov

Phase 2 Trial of Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

Clinical trial2026-07-21Results posted · ClinicalTrials.gov

A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Clinical trial2026-07-01Results expected Q4 2026 · ClinicalTrials.gov

Phase II Study of BEvacizumab (Avastin) in Combination With Atezolizumab or Atezolizumab (Tencentriq) and Cobimetinib (Cotellic) in Patients With Untreated Melanoma Brain Metastases (TACo-BEAT-MBM)

Clinical trial2026-06-25Results expected Q2 2028 · ClinicalTrials.gov

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

Clinical trial2026-06-23Results expected Q1 2028 · ClinicalTrials.gov

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) or Atezolizumab + Eribulin (AE) in Patients With Recurrent/Metastatic Inflammatory Breast Cancer

Clinical trial2026-06-10Results expected Q4 2027 · ClinicalTrials.gov

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

Clinical trial2026-06-10Results posted · ClinicalTrials.gov

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Clinical trial2026-06-08Results expected Q1 2028 · ClinicalTrials.gov

Label change: COBIMETINIB (NDA206192)

Regulatory2023-05-31FDA

Indication expansion: COBIMETINIB (NDA206192)

Regulatory2022-10-28FDA

Indication expansion: COBIMETINIB (NDA206192)

Regulatory2022-07-28FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Cobimetinib
Aliases & brands
Cotellic
RxNorm CUI
1722365
ChEMBL ID
CHEMBL2146883
ATC codes
L01EE02
UNII
ER29L26N1X
Primary mechanism
Dual specificity mitogen-activated protein kinase kinase 1 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Dual specificity mitogen-activated protein kinase kinase 1
MAP2K1 · Q02750
INHIBITORDual specificity mitogen-activated protein kinase kinase 1 inhibitor
Dual specificity mitogen-activated protein kinase kinase 2
MAP2K2 · P36507
INHIBITORDual specificity mitogen-activated protein kinase kinase 2 inhibitor

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-11-10
Latest approval
2022-10-28
Authorities
FDA
Total events
7
fdaU.S. Food and Drug Administration· 7 events
2026-08-20Label change
Label change: COBIMETINIB (NDA206192)
Evidence ↗
2023-05-31Label change
Label change: COBIMETINIB (NDA206192)
Evidence ↗
2022-10-28Indication expansion
Indication expansion: COBIMETINIB (NDA206192)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

94 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
94
registered trials across all phases
LATEST COMPLETION 2026
25
Active studies
8
Recruiting
10
Late-stage (III+)
46
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 94
Early Phase 12Phase 127Phase 1 / 213Phase 242Phase 2 / 32Phase 37Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

RecruitingPH II/IIICancer Research UKn=302029

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Active, not recruitingPH IIIKey trialHoffmann-La Rochen=1,0002028

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Active, not recruitingPH II/IIIKey trialHoffmann-La Rochen=1,0002026

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

CompletedPH IIIHoffmann-La Rochen=5142024

Cobimetinib for BRAF-wild-type or Mutated Histiocytoses : a Randomized, Placebo-controlled, Double Blind Study" COBRAH Study

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=542022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase 1b Study of IDH Inhibition With Enasidenib and MEK Inhibition With Cobimetinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-Occurring IDH2 and RAS Signaling Gene Mutations

CompletedPH ICity of Hope Medical Centern=32026

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

CompletedPH I/IIHoffmann-La Rochen=2142025

COBI-AVM Study - Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib In Extracranial Arteriovenous Malformations (AVM)

CompletedPH IIUniversity of Arkansasn=32025

Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma: A Pilot Clinical Trial

CompletedPH IIMayo Clinicn=642025

A Multicentre, Open-label, Phase I-II Study Evaluating the Combination of a MEK Inhibitor and a PDL1 Inhibitor in Pediatric and Adult Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma.

CompletedPH I/IICentre Leon Berardn=2292025

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

CompletedPH I/IIHoffmann-La Rochen=3412025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.