CLINICAL TRIALS PROFILE FOR TRAMETINIB DIMETHYL SULFOXIDE

All Clinical Trials for TRAMETINIB DIMETHYL SULFOXIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01725100 ↗	A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies	Completed	GlaxoSmithKline	Phase 1	2013-02-05	This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study with incomplete wash-out in subjects with solid tumors to determine the relative bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared with standard reference formulation trametinib. Approximately 18 subjects will be randomized to receive either a single dose of Treatment A (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B) followed by a 7 day incomplete wash-out period, then a single dose of the other treatment. Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1 followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety assessments, including assessment of AEs, clinical laboratory (hematology and clinical chemistry) and vital signs, will be made throughout the study. After a subject completes the study, he or she may be eligible to enter study MEK114375, an open-label rollover study of trametinib (no wash-out period or follow-up visit required) and continue receiving trametinib. For those subjects who wish to discontinue or complete the current study and choose not enter the rollover study, a follow-up visit should be performed within 21 days after receiving the last dose of study treatment.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	GlaxoSmithKline	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	Novartis Pharmaceuticals	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.
NCT02101788 ↗	Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer	Active, not recruiting	NRG Oncology	Phase 2/Phase 3	2014-04-11	This phase II/III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen, paclitaxel, pegylated liposomal doxorubicin, or topotecan in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back (recurrent), become worse (progressive), or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.

Clinical Trial Conditions for TRAMETINIB DIMETHYL SULFOXIDE

Condition Name

Condition Name for TRAMETINIB DIMETHYL SULFOXIDE
Intervention	Trials
Hematopoietic and Lymphoid Cell Neoplasm	5
Refractory Lymphoma	4
Refractory Malignant Solid Neoplasm	4
Refractory Plasma Cell Myeloma	4

Condition MeSH

Condition MeSH for TRAMETINIB DIMETHYL SULFOXIDE
Intervention	Trials
Neoplasms	7
Skin Neoplasms	5
Melanoma	5
Neoplasms, Plasma Cell	4

Clinical Trial Locations for TRAMETINIB DIMETHYL SULFOXIDE

Trials by Country

Trials by Country for TRAMETINIB DIMETHYL SULFOXIDE
Location	Trials
United States	210
United Kingdom	4
Puerto Rico	1

Trials by US State

Trials by US State for TRAMETINIB DIMETHYL SULFOXIDE
Location	Trials
Pennsylvania	11
California	7
Maryland	6
Georgia	6
Texas	6

Clinical Trial Progress for TRAMETINIB DIMETHYL SULFOXIDE

Clinical Trial Phase

Clinical Trial Phase for TRAMETINIB DIMETHYL SULFOXIDE
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TRAMETINIB DIMETHYL SULFOXIDE
Clinical Trial Phase	Trials
Active, not recruiting	9
Recruiting	2
Completed	2

Clinical Trial Sponsors for TRAMETINIB DIMETHYL SULFOXIDE

Sponsor Name

Sponsor Name for TRAMETINIB DIMETHYL SULFOXIDE
Sponsor	Trials
National Cancer Institute (NCI)	12
GlaxoSmithKline	2
NRG Oncology	1

Sponsor Type

Sponsor Type for TRAMETINIB DIMETHYL SULFOXIDE
Sponsor	Trials
NIH	13
Other	5
Industry	3

TRAMETINIB DIMETHYL SULFOXIDE Market Analysis and Financial Projection

Last updated: April 27, 2026

Clinical Trials Update, Market Analysis, and Projection: TRAMETINIB DIMETHYL SULFOXIDE

What is trametinib dimethyl sulfoxide (and how does it map to marketed trametinib)?

Trametinib dimethyl sulfoxide is the salt form of trametinib (a MEK1/2 inhibitor). In most commercial and clinical contexts, market activity and prescribing are tied to the active moiety trametinib, with the salt form appearing in filings and manufacturing disclosures rather than as a separate therapeutic product category.

Commercially, trametinib is primarily associated with Mekinist (U.S. tradename). Clinical outcomes, uptake, and revenue trends typically track trametinib as a drug substance, not the specific salt identity.

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What does the latest clinical pipeline look like for trametinib (MEK inhibitor class) via salt-form filings?

A full, drug-specific “latest clinical trials update” for trametinib dimethyl sulfoxide depends on whether trials are registered under that exact salt name versus the active ingredient trametinib. Public trial registries overwhelmingly register trametinib, not the dimethyl sulfoxide salt. In practice, pipeline visibility for the salt tracks the ongoing clinical evaluation of trametinib across combination regimens and label-expansion studies.

Market-critical point: for investment and R&D planning, the actionable view is the trametinib active clinical lifecycle (registrations, line extensions, and competitor displacement), not the salt name.

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How large is the trametinib opportunity, and what drives demand?

What is the current commercial positioning of trametinib?

Trametinib is used in oncology, with commercial value driven by:

• Indication mix (melanoma and other approved tumor contexts where MEK inhibition has a role)
• Combination therapy adoption (where trametinib is paired with targeted agents or immunotherapy strategies)
• Line-of-therapy dynamics (how quickly it moves in practice and whether it holds share when new MEK inhibitors or next-gen pathway agents launch)

Demand drivers that matter for projections

• Sequencing relative to other MAPK pathway inhibitors and competing targeted drugs
• Durability of response versus competing regimens in real-world settings
• Adoption constraints: toxicity management, combination regimen complexity, reimbursement, and guideline inclusion

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What is the market baseline for trametinib?

The market baseline for trametinib is constrained by the typical late-stage profile of branded oncology assets:

• Evolving use as new regimens enter formularies
• Patent and exclusivity timelines shifting the risk profile
• Exclusivity and competition from other MEK inhibitors and combination products

Given the inability to cite fresh, salt-specific trial datasets within this response, the projection and market analysis below are anchored to the trametinib active market logic, where the salt has no separate prescribing category.

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Clinical Trials Update: What phase activity and label expansion patterns should be modeled?

What clinical trial themes remain most relevant for trametinib commercialization?

For market impact, trametinib programs generally cluster around:

• Combination regimens (MEK inhibitor plus targeted therapy, or MEK plus immunotherapy, depending on tumor type and biomarker strategy)
• Biomarker-enriched studies (to increase response rates and reduce non-responsive populations)
• Line-extension trials (earlier lines or expanded subtypes to widen the eligible population)

Modeling implication: even if a salt-form filing shows no independent clinical differentiation, label expansion of the active ingredient changes TAM in practice. For trametinib, the commercially meaningful unit is trametinib label status and real-world regimen inclusion.

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Market Analysis & Projection: How should investors underwrite trametinib into 2030+?

What market model fits trametinib’s dynamics?

For a branded oncology MEK inhibitor with combination penetration, a practical projection model is:

1. Volume growth from label expansion and regimen uptake
2. Price erosion from competition and guideline shifts
3. Share volatility from launches in the same pathway
4. Patent/exclusivity and generic entry risk (which can dominate the revenue curve)

What revenue curve is most likely without new breakthroughs?

In late branded oncology assets, absent major late-stage breakthroughs:

• Revenue tends to follow an S-curve into peak followed by gradual decline that accelerates around exclusivity expiration or intensified competitor displacement.
• Combination uptake can temporarily stabilize the curve, but price and formulary pressures often reintroduce decline.

What upside scenarios matter?

The credible upside cases are limited:

• New tumor types or biomarker-defined cohorts that add a durable incremental population
• Preferred combination positioning that becomes guideline standard in specific settings
• Improved tolerability or dosing convenience through regimen-level optimization (not necessarily a new molecular form)

What downside scenarios dominate?

Downside typically comes from:

• Earlier generic entry or intensified brand-to-generic price pressure
• Loss of guideline position to better efficacy or tolerability competitors
• Combination regimen discontinuation due to toxicity management constraints

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Regulatory and patent posture: what should be treated as the risk driver?

For trametinib dimethyl sulfoxide, the salt form itself is generally a formulation IP lever, not a separate clinical asset. The dominant risk driver for valuation is:

• Active ingredient IP and regulatory exclusivity for trametinib
• Manufacturing and process patent layers that can delay biosubstitution or generic formulations

In underwriting, you should treat the salt as:

• Lower-level incremental protection (formulation/manufacturing IP)
• Not as a primary determinant of time-to-generic competition unless filings establish meaningful process or polymorph constraints that survive legal scrutiny.

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Key Takeaways

• Trametinib dimethyl sulfoxide is a salt form; market and clinical activity track trametinib (active ingredient) rather than the salt as a separate therapeutic product.
• Clinical impact for projection should model trametinib active label expansions and combination adoption patterns.
• Revenue trajectory should be underwritten to late-branded oncology dynamics: combination-led stabilization followed by competition-driven decline, with exclusivity and patent posture the key risk driver.
• Salt-form IP is generally a secondary protection layer; the valuation hinge is trametinib’s active ingredient and regulatory protection.

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FAQs

1. Is trametinib dimethyl sulfoxide clinically distinct from trametinib?
   It is a salt form of trametinib; clinical efficacy and prescribing typically map to the trametinib active ingredient.

2. Do clinical trials register the salt name?
   Most registries index trials by the active ingredient trametinib, not the salt form.

3. What drives trametinib demand most: monotherapy or combinations?
   Combination positioning and eligible patient expansion typically drive the higher-impact utilization changes.

4. What is the biggest risk to trametinib revenue projections?
   Patent and regulatory exclusivity timing combined with formulary price pressure and competitor displacement.

5. Does salt-formulation IP meaningfully extend exclusivity?
   Usually it adds formulation or process protection, but the valuation hinge remains active-ingredient exclusivity unless legal scope delays generic entry.

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References

[1] U.S. Food and Drug Administration. “Mekinist (trametinib) prescribing information.” FDA label (most current version on FDA website).