Cotellic

(Cobimetinib)

ApprovedSmall molecule

Cobimetinib is used to treat certain types of skin cancer (melanoma) that have a specific genetic mutation. It works by slowing or stopping the growth of cancer cells.[2] Cotellic is currently approved and in use across 20 indications[4].[1]

Cotellic is one of 435 small molecule programs targeting Cerebral arteriovenous malformation. It is currently in Approved.

Indications

Total Trials

Active Trials

434

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cerebral Arteriovenous MalformationApproved

Cutaneous MelanomaApproved

Biliary Tract CancerActive, not recruiting

Chronic Myelomonocytic LeukemiaApproved

Differentiated Thyroid CarcinomaRecruiting

Non-Small Cell Lung CancerCompleted

Breast CancerCompleted

MelanomaTerminated

CholangiocarcinomaActive, not recruiting

Acute Myeloid LeukemiaCompleted

Cerebral Arteriovenous MalformationApproved

Approved

Cutaneous MelanomaApproved

Approved

Biliary Tract CancerPhase 2

Active, not recruiting

Chronic Myelomonocytic LeukemiaApproved

Approved

Differentiated Thyroid CarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 2

Completed

Breast CancerPhase 2

Completed

MelanomaPhase 3

Terminated

CholangiocarcinomaPhase 3

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Completed

Showing 10 of 20 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Cotellic

Roche

Approved

3 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Differentiated Thyroid Carcinoma

NCT06440850

Phase 2Recruiting

Cancer

NCT05159245

Phase 1Active, not recruiting

Melanoma

NCT04835805

Q1 2027

Phase 1/2Active, not recruiting

Soft Tissue Sarcoma

NCT04216953

Phase 1Active, not recruiting

Advanced Endometrial Carcinoma

NCT05691504

Q2 2027

Phase 1Active, not recruiting

Acute Myeloid Leukemia

NCT05441514

Clinical

Trials by Indication[1]

Melanoma21 trials

A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Terminated· Roche logo

Roche·Phase 3·NCT03273153·446 enrolled

Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma

Completed· Roche logo

Roche·Phase 1·NCT03178851·155 enrolled

Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

Active, not recruiting·MMayo Clinic·Phase 2·NCT03554083·59 enrolled

Show 18 more trials

Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

Active, not recruiting·UUnknown Sponsor·Phase 2·NCT04722575·95 enrolled

The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma

Terminated·GGeorgetown University·Phase 2·NCT01813214·5 enrolled

Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC

Terminated·UUniversity Hospital Tuebingen·Phase 2·NCT02303951·47 enrolled

A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])

Completed· Roche logo

Roche··NCT03139513·200 enrolled

Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

Terminated·UUnknown Sponsor·Phase 2·NCT02230306·5 enrolled

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

Completed· Roche logo

Roche·Phase 2·NCT02768207·40 enrolled

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Completed· Roche logo

Roche·Phase 3·NCT02908672·514 enrolled

Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 3·NCT02427893

Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma

Terminated·YYana Najjar·Phase 1·NCT02818023·9 enrolled

A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

Completed· Roche logo

Roche·Phase 2·NCT03625141·80 enrolled

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

Completed·—·Phase 1/2·NCT03101254·5 enrolled

Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Completed·UUniversity Hospital, Essen·Phase 2·NCT02902029·186 enrolled

XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02721459·26 enrolled

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

Terminated·TTechnische Universität Dresden·Phase 2·NCT03430947·20 enrolled

Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

Terminated·MMelanoma Research Foundation Breakthrough Consortium·Phase 2·NCT01495988·10 enrolled

Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases

Unknown status·SSunnybrook Health Sciences Centre·Phase 2·NCT02036086·24 enrolled

Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation

Completed·UUnknown Sponsor·Phase 1/2·NCT01959633·11 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 1·NCT04835805·65 enrolled

Metastatic Melanoma6 trials

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed· Pfizer logo

Pfizer··NCT05260684·716 enrolled

IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

Completed·IInxMed (Shanghai) Co., Ltd.·Phase 1·NCT04109456·51 enrolled

A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma

Completed· Roche logo

Roche·Phase 1·NCT01656642·67 enrolled

Show 3 more trials

Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

Terminated·UUnknown Sponsor·Phase 2·NCT03224208·9 enrolled

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

Completed· Roche logo

Roche·Phase 3·NCT01689519·495 enrolled

A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Completed· Roche logo

Roche·Phase 1·NCT01271803·131 enrolled

Locally Advanced or Metastatic Solid Tumors4 trials

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT02457793·24 enrolled

Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Terminated· Roche logo

Roche·Phase 1·NCT00996892·178 enrolled

Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01988896·153 enrolled

Show 1 more trial

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01562275·67 enrolled

Breast Cancer3 trials

Pre-operative Immunotherapy Combination Strategies in Breast Cancer

Completed·QQueen Mary University of London·Phase 2·NCT03395899·71 enrolled

Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03202316·37 enrolled

Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1/2·NCT03566485·12 enrolled

Cancer3 trials

A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Active, not recruiting·UUppsala University Hospital·Phase 2·NCT04185831·167 enrolled

Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients

Withdrawn· Roche logo

Roche·Phase 1·NCT01974258

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

49 more indications

Ovarian Cancer3 trials

A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer

Completed· Roche logo

Roche·Phase 1·NCT03695380·77 enrolled

BEACON - A Phase II Study of Bevacizumab, Atezolizumab and Cobimetinib in Patients With Recurrent Platinum Resistant High Grade Serous Ovarian Cancer

Completed·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT03363867·30 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Non-Small Cell Lung Cancer3 trials

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03337698·314 enrolled

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

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

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 recruiting· Roche logo

Roche·Preclinical·NCT03178552·1,000 enrolled

ART2 trials

A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01277718·20 enrolled

A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01249131·20 enrolled

Acute Myeloid Leukemia2 trials

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Completed· Roche logo

Roche·Phase 1·NCT02670044·88 enrolled

Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Active, not recruiting·—·Phase 1·NCT05441514·3 enrolled

Treatment2 trials

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

Recruiting·CCancer Research UK·Phase 2/3·NCT05768178·30 enrolled

Solid Tumors2 trials

Study of Cobimetinib in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT00467779·119 enrolled

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

Completed· Roche logo

Roche·Phase 1/2·NCT02639546·56 enrolled

BRAF2 trials

Cobimetinib for BRAF-wild-type or Mutated Histiocytoses

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04007848·54 enrolled

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)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03175432·29 enrolled

Advanced Solid Tumors1 trial

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT02091141·673 enrolled

Gastrointestinal1 trial

Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors

Completed· Roche logo

Roche·Phase 1·NCT02876224·51 enrolled

Colorectal Cancer1 trial

Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer

Withdrawn·NNiharika Mettu·Phase 2·NCT03340558

Biliary Tract Cancer1 trial

Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04941287·57 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Liver1 trial

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

Completed· Roche logo

Roche·Phase 1·NCT02300025·28 enrolled

Venous malformation1 trial

Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)

Completed·UUniversity of Arkansas·Phase 2·NCT05125471·3 enrolled

Metastatic Cancer1 trial

A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS

Completed· Roche logo

Roche·Phase 1·NCT01986166·23 enrolled

Efficacy and Safety1 trial

A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT03264066·87 enrolled

Randomized1 trial

A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

Completed· Roche logo

Roche·Phase 1·NCT02136524·28 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Immune Checkpoint Blockade1 trial

Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

Terminated·—·Phase 1/2·NCT04214418·27 enrolled

Tic Disorder1 trial

Single-agent Cobimetinib for Adults With Histiocytic Disorders

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02649972·35 enrolled

Rare Tumor1 trial

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03108131·49 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03193190·341 enrolled

Differentiated Thyroid Carcinoma1 trial

Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation

Recruiting·—·Phase 2·NCT06440850·21 enrolled

Metastatic Colorectal Cancer1 trial

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Completed· Roche logo

Roche·Phase 2·NCT02291289·1,044 enrolled

Gallbladder Cancer1 trial

Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03201458·86 enrolled

Refractory Solid Tumors1 trial

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

Completed· Revolution Medicines logo

Revolution Medicines·Phase 1/2·NCT03989115·113 enrolled

Tics1 trial

A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01929876·16 enrolled

Soft Tissue Sarcoma1 trial

MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma

Active, not recruiting·CCentre Leon Berard·Phase 1/2·NCT04216953·320 enrolled

Advanced1 trial

A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

Active, not recruiting·MMassachusetts General Hospital·Phase 1/2·NCT03202940·16 enrolled

Multiple Myeloma1 trial

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma

Completed· Roche logo

Roche·Phase 1/2·NCT03312530·49 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Colorectal Adenocarcinoma1 trial

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Completed· Roche logo

Roche·Phase 3·NCT02788279·363 enrolled

Triple-Negative Breast Cancer1 trial

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Terminated· Roche logo

Roche·Phase 2·NCT02322814·169 enrolled

Combination Therapy1 trial

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02060188·385 enrolled

Patients With Advanced Solid Tumors1 trial

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

Terminated·AABM Therapeutics Corporation·Phase 1·NCT04190628·53 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT01928394·1,163 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Metastatic Lung Non-Small Cell Carcinoma1 trial

A Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03600701·53 enrolled

Chronic Myelomonocytic Leukemia (CMML)1 trial

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

Active, not recruiting·UUniversity of Utah·Phase 2·NCT04409639·14 enrolled

Langerhans Cell Histiocytosis1 trial

A Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib in Refractory Langerhans Cell Histiocytosis, LCH-Associated Neurodegenerative Disease, and Other Histiocytic Disorders.

Recruiting·CCarl Allen·Phase 2·NCT04079179·90 enrolled

Advanced Endometrial Carcinoma1 trial

A Phase 1 Study of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05691504·42 enrolled

BRAF V600E Mutation Present1 trial

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03224767·24 enrolled

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04005690·90 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

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)

Terminated· Roche logo

Roche·Preclinical·NCT03281369·219 enrolled

Metastatic Thyroid Gland Carcinoma1 trial

Atezolizumab Combinations With Chemotherapy for Anaplastic and Poorly Differentiated Thyroid Carcinomas

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03181100·50 enrolled

Locally Advanced Pancreatic Adenocarcinoma1 trial

A Phase I, Open-Label, Dose Finding Study of Calaspargase Pegol-Mnkl in Combination With Cobimetinib in Locally-Advanced or Metastatic Pancreatic Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT05034627·15 enrolled

Pancreatic Ductal Carcinoma1 trial

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

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06813079·25 enrolled

Cholangiocarcinoma1 trial

FIGHT-302: Pemigatinib vs Chemo in FGFR2+ CCA

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04551521·432 enrolled

Unspecified1 trial

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 recruiting· Roche logo

Roche·Phase 3·NCT03768063·1,000 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 10, 2015

COTELLIC

NDA NDA206192

May 31, 2016

COTELLIC

NDA NDA206192

Jan 26, 2018

COTELLIC

NDA NDA206192

Jul 28, 2022

COTELLIC

NDA NDA206192

Oct 28, 2022

COTELLIC

NDA NDA206192

May 31, 2023

COTELLIC

NDA NDA206192

Aug 20, 2026

COTELLIC

NDA NDA206192

Sources

References

[1]
ClinicalTrials.gov — 95 trial records for Cobimetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cotellic drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cobimetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cobimetinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206192). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cotellic. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dual Specificity Mitogen-Activated Protein Kinase Kinase 1 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Apr 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11597699Oct 5, 2026

8362002Oct 5, 2026

8362002*PEDApr 5, 2027

7803839Nov 10, 2029

7803839*PEDMay 10, 2030

8 more patents

11087354Jun 22, 2034

11087354*PEDDec 22, 2034

10478400Jun 29, 2036

11254649Jun 30, 2036

10590102Jun 30, 2036

10478400*PEDDec 29, 2036

11254649*PEDDec 30, 2036

10590102*PEDDec 30, 2036

Cotellic

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Melanoma21 trials

Metastatic Melanoma6 trials

Locally Advanced or Metastatic Solid Tumors4 trials

Breast Cancer3 trials

Cancer3 trials

Ovarian Cancer3 trials

Non-Small Cell Lung Cancer3 trials

ART2 trials

Acute Myeloid Leukemia2 trials

Treatment2 trials

Solid Tumors2 trials

BRAF2 trials

Advanced Solid Tumors1 trial

Gastrointestinal1 trial

Colorectal Cancer1 trial

Biliary Tract Cancer1 trial

Trial1 trial

Liver1 trial

Venous malformation1 trial

Metastatic Cancer1 trial

Efficacy and Safety1 trial

Randomized1 trial

Pilot Study1 trial

Immune Checkpoint Blockade1 trial

Tic Disorder1 trial

Rare Tumor1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Differentiated Thyroid Carcinoma1 trial

Metastatic Colorectal Cancer1 trial

Gallbladder Cancer1 trial

Refractory Solid Tumors1 trial

Tics1 trial

Soft Tissue Sarcoma1 trial

Advanced1 trial

Multiple Myeloma1 trial

Cancer of Unknown Primary Site1 trial

Colorectal Adenocarcinoma1 trial

Triple-Negative Breast Cancer1 trial

Combination Therapy1 trial

Patients With Advanced Solid Tumors1 trial

Advanced or Metastatic Solid Tumors1 trial

Immunotherapy1 trial

Metastatic Lung Non-Small Cell Carcinoma1 trial

Chronic Myelomonocytic Leukemia (CMML)1 trial

Langerhans Cell Histiocytosis1 trial

Advanced Endometrial Carcinoma1 trial

BRAF V600E Mutation Present1 trial

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Metastatic Thyroid Gland Carcinoma1 trial

Locally Advanced Pancreatic Adenocarcinoma1 trial

Pancreatic Ductal Carcinoma1 trial

Cholangiocarcinoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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