How many clinical trials are studying Cobimetinib?

5 recruiting trials in our tracked data involve Cobimetinib.

What conditions is Cobimetinib being studied for?

In our tracked recruiting trials, Cobimetinib is being studied in trials for Erdheim-Chester Disease, Lung cancer, Melanoma.

Cobimetinib: clinical trials recruiting now

Q: Is Cobimetinib FDA-approved?

Yes. According to the FDA drug label available through openFDA, Cobimetinib is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Cobimetinib appears in the FDA drug-label database. Marketed as Cotellic.

FDA-approved use

COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Superpotent Drug: An oversized tablet was found in a bottle. — Genentech Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2017-03-13

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 2 4 Phase 3 1

Conditions being studied

Condition	Trials
Erdheim-Chester Disease	2
Lung cancer	2
Melanoma	2
Pancreatic cancer	2
Advanced Cancer	1
Advanced or Metastatic Melanoma	1
Borderline Resectable Pancreatic Ductal Adenocarcinoma	1
Carcinoma, Non-Small-Cell Lung	1
Colorectal Neoplasms	1
Colorectal cancer	1
Epithelial Tumor	1
Glioma	1
Haematological Malignancy	1
Histiocytic Disorders, Malignant	1
Histiocytic Sarcoma	1

Recruiting trials involving Cobimetinib

Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
NCT07449754 · Phase: Phase 2 · Ages: 19 Years and older · Sex: All (male and female) · 10 locations
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
NCT04079179 · Phase: Phase 2 · Ages: No age limits stated · Sex: All (male and female) · 12 locations
DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.
NCT05768178 · Phase: Phase 2, Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 16 locations
Targeted Pathway Inhibition in Patients With Pancreatic Cancer
NCT04005690 · Phase: Early Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Using Tumor Models to Determine Treatments
NCT06813079 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Cobimetinib FDA-approved?

Yes, marketed as Cotellic.

How many recruiting trials involve Cobimetinib?

5 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.