MEKINIST (trametinib dimethyl sulfoxide) · Novartis
Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of various cancers harboring BRAF V600E or V600K mutations. It is used as a monotherapy or in combination with dabrafenib for unresectable or metastatic melanoma, and as adjuvant treatment for melanoma with lymph node involvement following complete resection. In combination with dabrafenib, it is also indicated for: * Metastatic non-small cell lung cancer (NSCLC). * Locally advanced or metastatic anaplastic thyroid cancer (ATC) with no satisfactory locoregional options. * Pediatric patients (1 year and older) with low-grade glioma (LGG) requiring systemic therapy. * Adult and pediatric patients (1 year and older) with unresectable or metastatic BRAF V600E-mutated solid tumors that have progressed following prior treatment.
How MEKINIST Works
Trametinib is a reversible inhibitor of MEK1 and MEK2 (mitogen-activated extracellular signal-regulated kinase) activation and kinase activity. MEK proteins are essential components of the MAPK (RAS/RAF/MEK/ERK) signaling pathway
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-05-29
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
MEKINIST Approval History
What MEKINIST Treats
5 indicationsMEKINIST is approved for 5 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
- Anaplastic Thyroid Cancer
- Solid Tumors
- Low-Grade Glioma
MEKINIST Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
MEKINIST 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 MEKINIST's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MEKINIST treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MEKINIST
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
170 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) |
| NCT03919071 | NCI-2019-02289 NCI-2019-02289, ACNS1723 | Ph 2 | active not recruiting | Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma |
| NCT01989585 | NCI-2013-02103 NCI-2013-02103, 13-424 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma |
| NCT02196181 | NCI-2014-01470 NCI-2014-01470, S1320 | Ph 2 | active not recruiting | Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread |
| NCT04527549 results posted | EA6191 NCI-2020-04552, EA6191 | Ph 2 | terminated | Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma |
| NCT03975829 | CDRB436G2401 2023-509276-42-00 | Ph 4 | active not recruiting | Pediatric Long-Term Follow-up and Rollover Study |
| NCT04439279 results posted | NCI-2020-03272 NCI-2020-03272, EAY131-R | Ph 2 | active not recruiting | Testing Trametinib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol R) |
| NCT06475989 | EA3231 NCI-2024-03023, EA3231 | Ph 3 | recruiting | Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer |
| NCT02642042 results posted | NCI-2015-02250 NCI-2015-02250, S1507 | Ph 2 | active not recruiting | Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer |
| NCT07110246 PNOC037 | 25081 NCI-2025-04985 | Ph 2 | recruiting | Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas |
| NCT02079740 results posted | NCI-2014-00461 NCI-2014-00461, 13-505 | Ph 1, Ph 2 | active not recruiting | Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors |
| NCT03784014 MULTISARC | C16-40 2024-514873-22-00, 2017-002851-27 | Ph 3 | completed | Molecular Profiling of Advanced Soft-tissue Sarcomas |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT03363217 | Trametinib study TRAM-01 | Ph 2 | active not recruiting | Trametinib for Pediatric Neuro-oncology Patients With Refractory Tumor and Activation of the MAPK/ERK Pathway. |
| NCT07549646 VATCH | IRB 24-022959 GRT-00005473 | Ph 2 | active not recruiting | 24VA021; VATCH Trametinib for Ras/MAPK Pathway VAs |
| NCT03149029 results posted | 16-642 | Ph 2 | active not recruiting | Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma |
| NCT01682083 COMBI-AD results posted | 115532 2012-001266-15, CDRB436F2301 | Ph 3 | completed | Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). |
| NCT03340506 | CDRB436X2X02B 2023-509318-13-00 | Ph 4 | recruiting | Dabrafenib and/or Trametinib Rollover Study |
| NCT05849662 | T2020-004 | Ph 1, Ph 2 | recruiting | A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia |
| NCT05358249 KontRASt-03 | CJDQ443E12101 2021-006196-42 | Ph 1, Ph 2 | active not recruiting | Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation |
| NCT02152995 results posted | NCI-2014-01106 NCI-2014-01106, 13-157 | Ph 2 | active not recruiting | Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer |
| NCT04439292 results posted | NCI-2020-03273 NCI-2020-03273, EAY131-H | Ph 2 | active not recruiting | Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) |
| NCT04439318 results posted | NCI-2020-03343 NCI-2020-03343, EAY131-S1 | Ph 2 | active not recruiting | Testing Trametinib as a Potential Targeted Treatment in Cancers With NF1 Genetic Changes (MATCH-Subprotocol S1) |
| NCT01979523 results posted | NCI-2013-02091 NCI-2013-02091, 13-144 | Ph 2 | active not recruiting | Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma |
| NCT05518110 PaTcH | CTRIAL-IE 20-27 2021-006276-16 | Ph 2 | terminated | PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer |
| NCT02015117 | NCI-2013-02343 NCI-2013-02343, OSU 13197 | Ph 1 | active not recruiting | Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases |
| NCT03190915 results posted | NCI-2017-00921 NCI-2017-00921, ADVL1521 | Ph 2 | active not recruiting | Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia |
| NCT04485559 | 190819 NCI-2020-04097 | Ph 1 | recruiting | Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021) |
| NCT04439357 results posted | NCI-2020-03436 NCI-2020-03436, EAY131-S2 | Ph 2 | active not recruiting | Testing Trametinib as a Potential Targeted Treatment in Cancers With GNAQ or GNA11 Genetic Changes (MATCH-Subprotocol S2) |
| NCT03975231 | 21308 NCI-2019-02745, R01CA246553 | Ph 1 | recruiting | Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic 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 |
| NCT06582745 | 2023-058 | Ph 2 | recruiting | Targeted Approach to Langerhans Cell Histiocytosis (LCH) Using MEK Inhibitor, Trametinib |
| NCT04557956 | NCI-2020-07044 NCI-2020-07044, 202103077 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment |
| NCT07468071 KontRASt-R | CJDQ443B12105B 2025-523537-26-00 | Ph 1, Ph 2 | recruiting | Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments |
| NCT03899155 | CA209-8TT 2018-004362-34 | Ph 2 | recruiting | Pan Tumor Rollover Study |
| NCT04943224 TRAM | TRAM | Ph 2 | recruiting | Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients |
| NCT03244956 MERAIODE | 2017-000742-21 2017/2527 | Ph 2 | completed | Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer |
| NCT06804824 | VVD-159642-01 | Ph 1 | recruiting | A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors |
| NCT07477457 | 25-257 | Ph 2 | recruiting | A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma |
| NCT03091257 | 16-352 | Ph 1 | active not recruiting | A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT04417621 | CLXH254C12201 2020-000873-26 | Ph 2 | active not recruiting | Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma |
| NCT03501368 | MCC-19475 | Ph 1 | completed | Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma |
| NCT07440290 DETERMINE | CRUKD/21/004 - Treatment Arm 7 | Ph 2, Ph 3 | not yet recruiting | DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers. |
| NCT06346067 | ERAS-254-02 | Ph 3 | active not recruiting | A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) |
| NCT05907304 SEACRAFT-1 | ERAS-254-01 | Ph 1 | active not recruiting | A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations |
| NCT04675710 | 2020-0641 NCI-2020-09803, 2020-0641 | Ph 2 | active not recruiting | Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer |
| NCT02224781 results posted | NCI-2014-01747 NCI-2014-01747, EA6134 | Ph 3 | active not recruiting | Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma |
| NCT04903119 | MCC-20-MEL-11-PMC 1R01CA258751-01A1 | Ph 1 | recruiting | Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma |
| NCT02231775 | 2014-0409 NCI-2014-01969, 2014-0409 | Ph 2 | active not recruiting | Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation |
| NCT04201457 | PBTC-055 UM1CA081457, NCI-2019-06216 | Ph 1, Ph 2 | active not recruiting | A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration |
Showing 50 of 170 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.
MEKINIST FDA Label Details
Indications & Usage
FDA Label (PDF)MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following co...
MEKINIST Patents & Exclusivity
Patents (16 active)
Exclusivity
Pro Intelligence Preview
Deep insights for MEKINIST
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 192 active patents
Trial Analysis
- • 159 total trials
- • Stage: Stable
Competitive Landscape
- • 20 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