Data updated: May 26, 2026
MEKINIST (trametinib)
Genetically Validated
Trial Activity: Stable 62 active trials
Oncology
Approved 2013-05-29
MEKINIST is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer; Anaplastic Thyroid Cancer; Solid Tumors.
Source: FDA Label • Novartis
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
Novartis Pharmaceuticals conducting 26 trials (16%)
480 indications explored (Broad Platform)
→ melanoma (27 trials)
→ cancer (14 trials)
→ colorectal cancer (8 trials)
13
Indications
--
Phase 3 Trials
8
Priority Reviews
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-05-29
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET
MEKINIST Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
132 FDA actions from 2013 to 2026 · 11 indication expansions
Sep 2014 SUPPL
Mfg
Aug 2014 SUPPL
Mfg
What MEKINIST Treats
4 indicationsMEKINIST is approved for 4 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
Source: FDA Label
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
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 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.
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 MEKINIST
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
AUGTYRO
REPOTRECTINIB
Bristol-Myers Squibb
Shared indications:
Non-Small Cell Lung CancerSolid Tumors
📋
Clinical Trial Registry
157 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) |
| 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 |
| NCT03975829 | CDRB436G2401 2023-509276-42-00 | Ph 4 | recruiting | Pediatric Long-Term Follow-up and Rollover Study |
| 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 |
| 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 | suspended | Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021) |
| 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 |
| NCT07468071 KontRASt-R | CJDQ443B12105B 2025-523537-26-00 | Ph 1, Ph 2 | not yet 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 |
| 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 |
| NCT03333343 | CEGF816X2102 2024-511757-21-00 | Ph 1 | active not recruiting | Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC |
| NCT03225664 | 2017-0226 NCI-2018-01107, 2017-0226 | Ph 1, Ph 2 | active not recruiting | Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced |
| NCT04452877 results posted | CDRB436ECN01 | Ph 2 | completed | A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC |
| NCT03065387 | 2016-0430 NCI-2018-01218, 2016-0430 | Ph 1 | active not recruiting | Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation |
| NCT03087071 | 2016-0338 NCI-2017-00868, 2016-0338 | Ph 2 | active not recruiting | Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer |
| NCT04111458 | 1432-0001 2018-004757-24 | Ph 1 | active not recruiting | A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation) |
| NCT04294160 | CADPT01C12101 | Ph 1 | terminated | A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer |
| 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 |
| NCT01972347 Neo Combi | 200332 | Ph 2 | active not recruiting | Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma |
Showing 50 of 157 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
MEKINIST FDA Label Details
Indications & Usage
FDA Label (PDF)MEKINIST is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer; Anaplastic Thyroid Cancer; Solid Tumors.
View full patent landscape →
16 OB patents · 4 families ·
215 international docs across 44 countries
MEKINIST Patents & Exclusivity
Latest Patent: Feb 2034
Exclusivity: Sep 2030
Patents (16 active)
US10869869*PED
Expires Feb 28, 2034
US10869869
Expires Aug 30, 2033
US8580304*PED
Expires Jul 28, 2032
US9155706*PED
Expires Jul 28, 2032
US9271941*PED
Expires Jul 28, 2032
US9399021*PED
Expires Jul 28, 2032
US8580304
Expires Jan 28, 2032
US9271941
Expires Jan 28, 2032
US9399021
Expires Jan 28, 2032
US9155706
Expires Jan 28, 2032
US8703781*PED
Expires Apr 15, 2031
US8952018*PED
Expires Apr 15, 2031
US8703781
Expires Oct 15, 2030
US8952018
Expires Oct 15, 2030
US7378423*PED
Expires Nov 29, 2027
US7378423
Expires May 29, 2027
Exclusivity
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2030
PED
Until Sep 2030
PED
Until Sep 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2030
PED
Until Sep 2030
PED
Until Sep 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2026
PED
Until Sep 2030
PED
Until Sep 2030
PED
Until Sep 2030
Source: FDA Orange Book
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
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