Data updated: May 26, 2026
MEKTOVI (binimetinib)
Genetically Validated
Trial Activity: Stable 23 active trials
Orphan Drug
Oncology
Approved 2018-06-27
MEKTOVI is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer.
Source: FDA Label • ARRAY BIOPHARMA INC
How MEKTOVI Works
Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2. These proteins are key regulators of the ERK signaling pathway, which promotes cancer cell proliferation. By inhibiting MEK1/2, binimetinib reduces cancer cell viability and slows tumor growth. When used in combination with encorafenib (a BRAF inhibitor), the therapy targets two different nodes of the RAS/RAF/MEK/ERK pathway, resulting in enhanced anti-tumor activity and a delay in the emergence of treatment resistance compared to monotherapy.
Development Insights
Pfizer conducting 13 trials (20%)
235 indications explored (Broad Platform)
→ metastatic melanoma (7 trials)
→ melanoma (6 trials)
→ advanced malignant solid neoplasm (4 trials)
5
Indications
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2018-06-27
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
MEKTOVI Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2018 to 2025 · 4 indication expansions
What MEKTOVI Treats
2 indicationsMEKTOVI is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
Source: FDA Label
MEKTOVI 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.
MEKTOVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
3
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 9 more competitors across all three rings.
Upgrade to Pro 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 MEKTOVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MEKTOVI treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to MEKTOVI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
65 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT05554367 | NCI-2022-07266 NCI-2022-07266, EAY191-A3 | Ph 2 | active not recruiting | Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial |
| NCT05111561 | NCI-2021-11793 NCI-2021-11793, 10449 | Ph 1 | suspended | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer |
| NCT05564403 | NCI-2022-07833 NCI-2022-07833, EAY191-A6 | Ph 2 | active not recruiting | Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT04221438 results posted | EA6183 NCI-2019-07407, EA6183 | Ph 2 | terminated | Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement |
| NCT04439344 results posted | NCI-2020-03374 NCI-2020-03374, EAY131-Z1A | Ph 2 | active not recruiting | Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A) |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. |
| NCT05195632 OCEANII | W00090GE203 CTR20212962, CTR20212961 | Ph 2 | active not recruiting | Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer |
| NCT03971409 InCITe | 187519 NCI-2019-01531, TBCRC 047 | Ph 2 | active not recruiting | Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer |
| NCT05026983 | 2021-0205 NCI-2021-08716, 2021-0205 | Ph 2 | recruiting | Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases |
| NCT04061980 | 2020000039 IST-818-210X, CA209-73R | Ph 2 | active not recruiting | Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer |
| NCT04892017 | DCC-3116-01-001 2022-501474-19-00 | Ph 1 | terminated | Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors |
| NCT04657991 | C4221016 KEYNOTE-B80; STARBOARD, 2024-512038-13-00 | Ph 3 | active not recruiting | A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma |
| NCT05170334 | MCC-20955 | Ph 2 | active not recruiting | Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma |
| NCT04132505 | 2019-0191 NCI-2019-04991, 2019-0191 | Ph 1 | completed | Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer |
| NCT04322383 | 200075 20-C-0075 | Ph 2 | recruiting | Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant |
| NCT04324112 | 200076 20-C-0076 | Ph 2 | recruiting | Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL |
| NCT03915951 results posted | ARRAY-818-202 C4221008; PHAROS, 2024-515929-28-00 | Ph 2 | completed | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer |
| NCT05926960 PORTSIDE | C4221023 KEYNOTE PNC92; PORTSIDE, 2023-509471-17-00 | Ph 2 | terminated | A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma |
| NCT05554354 results posted | NCI-2022-07265 NCI-2022-07265, EAY191-N2 | Ph 2 | terminated | Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial) |
| NCT04903119 | MCC-20-MEL-11-PMC 1R01CA258751-01A1 | Ph 1 | recruiting | Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma |
| NCT03170206 | 16-531 | Ph 1 | completed | Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer |
| NCT03947385 | IDE196-001 | Ph 1, Ph 2 | recruiting | Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions |
| NCT04585815 results posted | B8011011 2020-002829-28 | Ph 1, Ph 2 | terminated | Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) |
| NCT02910700 | 2015-0605 NCI-2016-01940, 2015-0605 | Ph 2 | active not recruiting | Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma |
| NCT03991819 BiniPembro | BiniPembro CAPCR 18-5856 | Ph 1 | recruiting | Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer |
| NCT04543188 results posted | C4471001 2022-003184-23 | Ph 1 | terminated | A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement |
| NCT05510895 NeoBRAF | AIO-KRK-0420 | Ph 2 | completed | Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer |
| NCT04511013 | S2000 NCI-2020-05496, S2000 | Ph 2 | recruiting | A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases |
| NCT04598009 | 20863 NCI-2020-07748 | Ph 2 | recruiting | Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma |
| NCT02185690 MEK162 results posted | CMEK162ACA02T CMEK162ACA02T | Ph 1 | completed | A Phase I/Ib Study of MEK162, a MEK Inhibitor, in Combination With Carboplatin and Pemetrexed in Patients With Non-squamous Carcinoma of the Lung |
| NCT05304546 MK3475-C01 | 9222-22-SMC | Ph 2 | completed | Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma |
| NCT03106415 results posted | MC1632 NCI-2017-00496, 16-009051 | Ph 1, Ph 2 | completed | Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer |
| NCT03898908 EBRAIN-MEL results posted | GEM-1802 2018-002530-20 | Ph 2 | completed | Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain |
| NCT03231306 NF108-BINI results posted | IRB-170616001 516027 | Ph 2 | completed | Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas |
| NCT05615818 SAFIR-ABC10 | UC-GMP-2201 - PRODIGE 78 2022-000190-19, 2022-502403-30-00 | Ph 3 | recruiting | Personalized Medicine for Advanced Biliary Cancer Patients |
| NCT04720976 | JAB-3312-1003 | Ph 1, Ph 2 | completed | JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors |
| NCT03839342 BEAVER | BEAVER-001 / IST-818-207X | Ph 2 | active not recruiting | Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations |
| NCT04375527 | 19-002060 NCI-2020-02590 | Ph 2 | terminated | Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma |
| NCT03374254 results posted | 3475-651 MK-3475-651, KEYNOTE-651 | Ph 1 | completed | Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651) |
| NCT03973918 BRAF results posted | ABTC 1802 UM1CA137443 | Ph 2 | terminated | Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG |
| NCT04800822 | C4481001 2022-502431-18-00, 2022-003166-21 | Ph 1 | terminated | PF-07284892 in Participants With Advanced Solid Tumors |
| NCT03843775 results posted | 18-547 | Ph 1, Ph 2 | completed | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers |
| NCT03864042 results posted | ARRAY-818-103 C4221003, 2019-001036-66 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors |
| NCT03475004 results posted | 17-0466.cc | Ph 2 | completed | Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer |
| NCT03981614 results posted | ACCRU-GI-1618 NCI-2019-03480, ACCRU-GI-1618 | Ph 2 | completed | Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer |
| NCT04655157 QUAD01 results posted | HCC 20-190 CA209-7Y4 | Ph 1, Ph 2 | terminated | Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma |
| NCT04390243 results posted | ACCRU-GI-1907 NCI-2020-02972, ACCRU-GI- 1907 | Ph 2 | terminated | Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation |
| NCT03693170 ANCHOR-CRC results posted | W00090 GE 2 01 | Ph 2 | completed | Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer |
Showing 50 of 65 trials
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
MEKTOVI FDA Label Details
Indications & Usage
FDA Label (PDF)MEKTOVI is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer.
View full patent landscape →
7 OB patents · 3 families ·
325 international docs across 59 countries
MEKTOVI Patents & Exclusivity
Latest Patent: Oct 2033
Exclusivity: Oct 2026
Patents (7 active)
Exclusivity
I-928
Until Oct 2026
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for MEKTOVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 9 active patents
Trial Analysis
- • 65 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
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