ZELBORAF (vemurafenib)
Zelboraf is an oral medication that treats patients with advanced melanoma that has spread or cannot be removed by surgery. It is specifically used for individuals whose tumors carry the BRAF V600E mutation, as determined by a specialized test. This therapy also helps patients with Erdheim-Chester Disease who have a BRAF V600 mutation. It is important to note that this drug is not used for melanoma patients with the wild-type BRAF gene.
How ZELBORAF Works
This drug works by blocking specific mutated forms of the BRAF serine-threonine kinase, such as BRAF V600E. These mutations cause proteins to remain constantly active, which triggers cancer cells to grow and multiply without the usual growth factors. By inhibiting these proteins, the medication helps stop the uncontrolled cell proliferation associated with these specific genetic mutations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-08-17
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
ZELBORAF Approval History
What ZELBORAF Treats
2 indicationsZELBORAF is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Erdheim-Chester Disease
ZELBORAF 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.
ZELBORAF 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 ZELBORAF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZELBORAF treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZELBORAF
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
96 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03155620 results posted | NCI-2017-01251 NCI-2017-01251, APEC1621SC | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) |
| NCT02314481 DARWINII | 14/0274 | Ph 2 | completed | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity |
| NCT03554083 results posted | MC1776 NCI-2018-01018, MC1776 | Ph 2 | completed | Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT01787500 | 2012-0748 NCI-2013-00541, 2012-0748 | Ph 1 | completed | Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery |
| NCT06561360 | 24-160 | Ph 2 | recruiting | A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) |
| NCT04302025 | ML41591 | Ph 2 | recruiting | A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) |
| NCT05068752 results posted | HRI-Vemurafenib-Sorafenib-001 | Ph 2 | completed | Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer |
| NCT04943198 BRAVO | BRAVO | Ph 2 | recruiting | Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis |
| NCT03178552 B-FAST | BO29554 2017-000076-28 | Ph 2, Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
| NCT02721459 | MCC-18597 | Ph 1 | active not recruiting | XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma |
| NCT01909453 COLUMBUS results posted | CMEK162B2301 2013-001176-38, C4221004 | Ph 3 | completed | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma |
| NCT01659151 results posted | MCC-16992 | Ph 2 | completed | Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma |
| NCT03410875 | 17-513 | Ph 2 | active not recruiting | A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia |
| NCT06440850 | 21522 NCI-2024-02359, 21522 | Ph 2 | recruiting | Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation |
| NCT03181100 | 2016-0916 NCI-2019-02581, 2016-0916 | Ph 2 | active not recruiting | Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer |
| NCT05768178 DETERMINE | CRUKD/21/004 - Treatment Arm 5 IRAS ID: 1004057 | Ph 2, Ph 3 | recruiting | DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers. |
| NCT03498521 CUPISCO results posted | MX39795 2017-003040-20 | Ph 2 | completed | 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 |
| NCT01711632 results posted | 12-200 | Ph 2 | completed | BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia |
| NCT04462471 results posted | 20-053 | Ph 1 | completed | Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers |
| NCT02304809 AcSé | UC-0105/1401 2014 001225 33 | Ph 2 | active not recruiting | Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations |
| NCT02908672 results posted | CO39262 2016-002482-54 | Ph 3 | completed | 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 |
| NCT01378975 results posted | MO25743 | Ph 2 | completed | A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases |
| NCT03013491 results posted | CTMX-M-072-001 | Ph 1, Ph 2 | terminated | PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas |
| NCT02902029 ImmunoCobiVem | ImmunoCobiVem_2015 | Ph 2 | completed | 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 |
| NCT03224767 | A071601 NCI-2017-00740, U10CA180821 | Ph 2 | active not recruiting | Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma |
| NCT03220035 results posted | NCI-2017-01244 NCI-2017-01244, APEC1621G | Ph 2 | completed | Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) |
| NCT04551521 | NCT-PMO-1602 | Ph 2 | completed | CRAFT: The NCT-PMO-1602 Phase II Trial |
| NCT06692491 SPRING | PUShenzhenH RE [2024]No.(117) | Ph 2 | not yet recruiting | Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS |
| NCT02091141 results posted | ML28897 PRO 02 | Ph 2 | completed | 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 |
| NCT03101254 results posted | 17-030 | Ph 1, Ph 2 | completed | LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma |
| NCT05159245 FINPROVE | FINPROVE | Ph 2 | recruiting | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs |
| NCT02291289 MODUL results posted | MO29112 2014-001017-61 | Ph 2 | completed | A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) |
| NCT03625141 results posted | MO39136 2018-000759-41 | Ph 2 | completed | 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 |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT03430947 RadioCoBRIM | TUD-CoBRIM-67 2017-000768-13 | Ph 2 | terminated | Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases |
| NCT04790448 | VIC-BRAFMT-mCRC | Ph 1, Ph 2 | completed | Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer |
| NCT01657591 | MCC-17013 | Ph 1 | completed | Study of XL888 With Vemurafenib for Patients With Unresectable BRAF Mutated Stage III/IV Melanoma |
| NCT02052193 | ZDO 2012_PHOTOTOX | Ph 2 | terminated | Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study |
| NCT01689519 coBRIM results posted | GO28141 2012-003008-11 | Ph 3 | completed | A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma |
| NCT01959633 VEMUPLINT | VEMUPLINT 2013-003730-33 | Ph 1, Ph 2 | completed | Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation |
| NCT02818023 | 15-131 | Ph 1 | terminated | Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma |
| NCT01638676 | BCC-MEL-11-03 | Ph 1, Ph 2 | recruiting | A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients |
| NCT03224208 VECODUE | VECODUE | Ph 2 | terminated | Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients |
| NCT01597908 COMBI-v results posted | 116513 CDRB436B2302, 2011-006088-23 | Ph 3 | completed | Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma |
| NCT02303951 NEO-VC | EADO_VC_NEO_1 | Ph 2 | terminated | Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC |
| NCT01531361 | 2011-1183 NCI-2012-00217, 2011-1183 | Ph 1 | completed | Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations |
| NCT01739764 results posted | GO28399 2012-003144-80 | Ph 4 | completed | An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol |
| NCT02164916 results posted | S1406 U10CA180888, S1406 | Ph 2 | completed | S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer |
| NCT01942993 results posted | GCO 13-0427 | Ph 2 | terminated | The Effects of Treatment With Vemurafenib on the Immune System in Advanced Melanoma |
Showing 50 of 96 trials
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.
ZELBORAF FDA Label Details
Indications & Usage
FDA Label (PDF)ZELBORAF is indicated for the treatment of Melanoma; Erdheim-Chester Disease.
Pro Intelligence Preview
Deep insights for ZELBORAF
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 7 active patents
Trial Analysis
- • 97 total trials
- • Stage: Declining
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment