Mekinist

(Trametinib Dimethyl Sulfoxide)

Phase 3

Mekinist is one of 57 small molecule programs targeting Clinical Stage III Cutaneous Melanoma AJCC v8. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Clinical Stage III Cutaneous Melanoma AJCC V8Active, not recruiting

Advanced LymphomaActive, not recruiting

Clinical Stage IV Cutaneous Melanoma AJCC V8Terminated

Anaplastic AstrocytomaActive, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Phase 3

Active, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Clinical Stage IV Cutaneous Melanoma AJCC V8Phase 2

Terminated

Anaplastic AstrocytomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Advanced Lymphoma

#DrugCompanyPhaseTrials

Mekinist

Novartis

Phase 3

2 2

Ibrance

Pfizer

Phase 2

3 3

Mekinist

Novartis

Phase 2

3 4

Balversa

Johnson & Johnson

Phase 2

2 5

Vitrakvi

Bayer

Phase 2

2 6

Tagrisso

AstraZeneca

Phase 2

2 7

Sutent

Pfizer

Phase 2

2 8

Adavosertib

AstraZeneca

Phase 2

2 9

M6620

AstraZeneca

Phase 2

2 10

Alinamin

Roche

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8

NCT02224781

Phase 2Active, not recruiting

Advanced Lymphoma

NCT04439318

Q1 2027

Phase 2Active, not recruiting

Advanced Lymphoma

NCT04439357

PreclinicalActive, not recruiting

Clinical Stage IV Cutaneous Melanoma AJCC V8

NCT04557956

Phase 2Active, not recruiting

Stage III Cutaneous Melanoma AJCC V7

NCT02196181

Q3 2027

Phase 2Active, not recruiting

Anaplastic Astrocytoma

NCT03919071

Clinical

Trials by Indication[1]

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination With Dual BRAF/MEK Inhibition in Patients With BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04557956·16 enrolled

The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH

Terminated·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04527549·5 enrolled

Advanced Lymphoma2 trials

MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients With Tumors With NF1 Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439318·50 enrolled

MATCH Treatment Subprotocol S2: Phase II Study of Trametinib in Patients With Tumors With GNAQ or GNA11 Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439357·4 enrolled

Stage III Cutaneous Melanoma AJCC v71 trial

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02196181·280 enrolled

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02224781·267 enrolled

Ovarian Serous Tumor1 trial

A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients With Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT02101788·260 enrolled

1 more indication

Anaplastic Astrocytoma1 trial

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03919071·58 enrolled

Regulatory

FDA Approval Timeline[4]

May 28, 2013

MEKINIST

NDA NDA204114

Mar 15, 2023

MEKINIST

NDA NDA217513

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Trametinib Dimethyl Sulfoxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trametinib Dimethyl Sulfoxide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trametinib Dimethyl Sulfoxide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217513). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mekinist. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

May 28, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7378423May 28, 2027

7378423*PEDNov 28, 2027

8952018Oct 14, 2030

9399021Jan 27, 2032

9155706Jan 27, 2032

6 more patents

8580304Jan 27, 2032

9271941Jan 27, 2032

8580304*PEDJul 27, 2032

9155706*PEDJul 27, 2032

9271941*PEDJul 27, 2032

9399021*PEDJul 27, 2032

Mekinist

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Advanced Lymphoma2 trials

Stage III Cutaneous Melanoma AJCC v71 trial

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

Ovarian Serous Tumor1 trial

Anaplastic Astrocytoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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