COTELLIC

Peak

cobimetinib

NDAORALTABLETPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF V600E and K mutations result in constitutive activation of the…

Clinical Trials (5)

NCT05768178Phase 2/3Recruiting

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

Started Mar 2023
30 enrolled
Haematological MalignancyMelanomaThyroid Cancer, Papillary+9 more
NCT05034627Phase 1Active Not Recruiting

Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Started Aug 2022
15 enrolled
Locally Advanced Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaStage II Pancreatic Cancer AJCC v8+4 more
NCT05125471Phase 2Completed

Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)

Started Jul 2022
3 enrolled
Arteriovenous Malformations (Extracranial)
NCT04835805Phase 1Active Not Recruiting

A Study to Evaluate the Safety 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.

Started May 2021
65 enrolled
Melanoma
NCT04079179Phase 2Recruiting

Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

Started Apr 2021
90 enrolled
Langerhan's Cell HistiocytosisJuvenile XanthogranulomaErdheim-Chester Disease+4 more

Loss of Exclusivity

LOE Date
Dec 30, 2036
131 months away
Patent Expiry
Dec 30, 2036
Exclusivity Expiry
Oct 28, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8362002
Oct 5, 2026
U-1776
11597699
Oct 5, 2026
U-3554
8362002*PED
Apr 5, 2027
7803839
Nov 10, 2029
SubstanceProduct
7803839*PED
May 10, 2030