Trametinib dimethyl sulfoxide is under clinical development by Novartis and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Trametinib dimethyl sulfoxide’s likelihood of approval (LoA) and phase transition for Relapsed Multiple Myeloma took place on 04 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Trametinib dimethyl sulfoxide Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Trametinib dimethyl sulfoxide overview

Trametinib (GSK1120212, Mekinist) is an anti-cancer agent. It is formulated as tablets,  film coated tablets, coated tablets for oral route of administration. Trametinib is indicated as a single agent or in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with dabrafenib. Mekinist in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a FDA-approved test.

Trametinib is under development for the treatment of cholangiocarcinoma, metastatic biliary tract carcinoma, differentiated thyroid cancer (DTC), gallbladder cancer, lung adenocarcinoma, cetuximab-refractory colorectal cancer in combination with panitumumab, metastatic pancreatic cancer, plexiform neurofibroma, Langerhans cell histocytosis, arterio-venous malformations, anaplastic thyroid cancer, ampulla of Vater cancer). refractory and relapsed Multiple Myeloma, triple-negative breast cancer, endometrial cancer in combination with uprosertibm. It is under development for low grade glioma. It is also underdevelopment for the treatment of solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, primary brain tumors, NF-1 associated PF and LCH.

It was under development for the treatment of lymphoma and metastatic uveal melanoma, relapsed or refractory leukemia including acute myeloblastic leukemia, myelodysplastic syndrome,  advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder cancer, chronic myelomonocytic leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia ,glioma and metastatic transitional (urothelial) tract cancer and Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation, and it was also under development for the treatment of colorectal cancer, bladder cancer, pancreatic cancer,non-small cell lung cancer,ovarian cancer,head and neck cancer squamous cell carcinoma in combination with uprosertib. Afuresertib in combination with trametinib was under development for the treatment of prostate cancer, renal cell carcinoma, gastric cancer and hepatocellular cancer.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Trametinib dimethyl sulfoxide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Trametinib dimethyl sulfoxide
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • Non Malignant Disorders
  • Oncology
Key Developers
  • Sponsor Company: Novartis
  • Originator: Kyoto Prefectural University of Medicine and Japan Tobacco
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.