COTELLIC (cobimetinib fumarate)
Cotellic helps adults with advanced or spreading melanoma that carries specific genetic markers known as BRAF V600E or V600K mutations. For these patients, it is used in combination with another medication called vemurafenib to help manage the disease. It is also used as a standalone therapy for adults with a group of rare blood disorders called histiocytic neoplasms.
How COTELLIC Works
This medication works by blocking MEK1 and MEK2, which are proteins that help regulate cell growth through the MAPK/ERK pathway. By inhibiting these proteins, the drug slows down the uncontrolled cellular proliferation caused by certain genetic mutations. When used with vemurafenib, it targets two different parts of the same signaling pathway to increase cancer cell death and reduce tumor growth.
Details
- Status
- Prescription
- First Approved
- 2015-11-10
- Patent Cliff
- 2036
- Revenue
- $54M (FY-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
COTELLIC Approval History
What COTELLIC Treats
2 indicationsCOTELLIC is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Histiocytic Neoplasms
COTELLIC Target & Pathway
ProTarget
A kinase in the MAPK signaling pathway that regulates cell growth. BRAF mutations (especially V600E) occur in melanoma, colorectal, and thyroid cancers, causing uncontrolled cell proliferation. Inhibiting mutant BRAF blocks this aberrant growth signal.
COTELLIC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COTELLIC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COTELLIC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COTELLIC
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COTELLIC FDA Label Details
Indications & Usage
FDA Label (PDF)COTELLIC is indicated for the treatment of Melanoma; Histiocytic Neoplasms.
COTELLIC Patents & Exclusivity
Patents (13 active)
Exclusivity
Pro Intelligence Preview
Deep insights for COTELLIC
Revenue Insights
- • FY-2025: $54M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 13 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 11 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.