Delving into the Latest Updates on Dabrafenib Mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)

+ [18]

Target

BRAF x CRAF

Action

inhibitors

Mechanism

BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [6]

Active Indication

BRAF Fusion GliomaBRAF mutation positive hairy cell leukemiaBRAF mutation Solid Tumors+ [20]

Inactive Indication

Advanced Malignant Solid NeoplasmBile Duct NeoplasmsBRAF Mutation Ameloblastoma+ [31]

Originator Organization

GSK Plc

Active Organization

Beijing Novartis Pharma Co. Ltd.

Novartis AGNovartis Pharma AG

+ [8]

Inactive Organization

GlaxoSmithKline Biologicals SA

Novartis Pharmaceuticals Canada, Inc.

JS InnoPharm (Shanghai) Co., Ltd.

+ [3]

License Organization

Novartis AG

GSK Plc

Drug Highest PhaseApproved

First Approval Date

United States (29 May 2013),

BRAF V600E Mutation-Positive Melanoma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Fast Track (United States)

Login to view timeline

Structure/Sequence

Molecular FormulaC24H24F3N5O5S3

InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N

CAS Registry1195768-06-9

Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1/PD-L1 inhibition.
Preclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF/EGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy.
This is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.

Start Date01 Mar 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07440290

/ Not yet recruitingPhase 2/3IIT

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.

This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.
Investigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.
This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

Start Date01 Feb 2026

Sponsor / Collaborator

Cancer Research UK

[+3]

NCT07419932

/ RecruitingNot ApplicableIIT

Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study

This multicenter observational study aims to evaluate the safety and efficacy of neoadjuvant therapy in patients with locally advanced thyroid cancer, focusing on imaging, biochemical, and pathological responses, as well as short-term surgical outcomes and long-term prognosis.

Start Date23 Dec 2025

Sponsor / Collaborator

Fujian Medical University

100 Clinical Results associated with Dabrafenib Mesylate

Login to view more data

100 Translational Medicine associated with Dabrafenib Mesylate

Login to view more data

100 Patents (Medical) associated with Dabrafenib Mesylate

Login to view more data

2,682

Literatures (Medical) associated with Dabrafenib Mesylate

01 Dec 2026·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

Computational study on QSAR modeling, molecular docking, and ADMET profiling of pyrazole-modified catalpol derivatives as prospective dual inhibitors of VEGFR-2/BRAF V600E

Article

Author: Mandal, Manab ; Pal, Sumanta ; Ghosh, Narendra Nath ; Singh, Vivek Dutta ; Pati, Soumen Kumar

Pancreatic and Esophageal cancers are highly aggressive with high mortality and limited treatment, causing over 466,000 and 544,100 deaths worldwide in 2020 respectively. This highlights the urgent need for safer,and effective anticancer agents. Catalpol, a natural iridoid glycoside, shows anticancer potential, but due to its poor drug-like properties it requires structural modification. This study investigates pyrazole-modified catalpol derivatives as dual inhibitors for these cancers using Quantitative Structure Activity Relationship (QSAR) modelling, molecular docking, and pharmacokinetic studies. We analyzed fourteen pyrazole-modified catalpol derivatives with reported IC50values against four cancer cell lines(BxPC-3, PANC-1, Eca109, and EC9706). The molecules were optimized using DensityFunctional Theory (DFT), and 2D molecular descriptors were calculated using PaDEL. QSAR models were developed by utilizing a Genetic Function Algorithm (GFA) and Multiple Linear Regression (MLR) and validated using statistical metrics such as R², Q², R²adj, and R²pred. Docking studies targeted VEGFR-2 and BRAF V600E kinases using AutoDockVina, while ADMET and drug-likeness properties were predicted using SwissADME and pkCSM tools. The external validation R²pred values for BxPC-3, PANC-1, Eca109, and EC9706 cell lines were 0.9412, 0.9535, 0.9981, and 0.9935, respectively. Among the derivatives, compound 3k showed the highest binding affinity for VEGFR-2 (- 8.18 kcal/mol) and BRAF (- 8.64 kcal/mol), surpassing the control drugs etoposide (- 8.00 kcal/mol) and dabrafenib (- 8.15 kcal/mol) respectively. ADMET analysis confirmed good intestinal absorption, limited blood-brain barrier penetration, non-toxicity, acceptable total clearance, and compliance with Lipinski's rule. Overall, the study suggests that pyrazole-modified catalpol derivatives, especially compound 3k, are promising multi-target inhibitors for pancreatic and esophageal cancers, justify further in-vitro and in-vivo studies.

01 Apr 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Harnessing retinoic acid metabolism-related genes to identify lung adenocarcinoma subtype and establish a risk model for predicting prognosis and drug therapy response

Article

Author: Xu, Li ; Zhang, Weichu ; Zheng, Danting

BACKGROUND:

The metabolism of retinoic acid (RA) is associated with the progression of lung adenocarcinoma (LUAD), but the relationship between RA metabolism-related genes (RAMRGs) and LUAD prognosis remains unclear.

OBJECTIVES:

The goal of this study was to develop and validate a prognostic model based on RAMRGs for LUAD patients.

METHODS:

LASSO-Cox and multivariate Cox regression analyses were undertaken, with data from TCGA-LUAD used to identify RAMRGs to create a prognostic model and data from the GEO-LUAD cohort utilized to validate the model. The predictive ability of the model was further evaluated using the nomogram. In addition, functional enrichment analysis, immunological characteristics analysis, and sensitivity analysis of chemotherapy drugs were performed.

RESULTS:

A novel prognostic model containing 10 RAMRGs (CCDC17, CLCA1, CYP17A1, FETUB, IGF2BP1, IGFBP1, KCNB2, NTSR1, RPE65, and VGF) was established. The reliable prediction performance of this model in LUAD patients was verified. The DEGs in high-risk and low-risk groups were involved in neural activity of ligand-receptor interaction, Neutrophil extracellular trap formation, and metabolism of xenobiotics by cytochrome P450. The low-risk group had a higher abundance of aDCs, iDCs, Mast_cells, and Neutrophils, and had a higher chance of benefiting from immunotherapy. In both groups, TP53 showed the highest mutation rates, with the high-risk group exhibiting a higher rate than the low-risk group (60 % vs. 39 %). In addition, Dabrafenib, ARQ-680, Vemurafenib, BGB-283, and MLN-2480 were potential therapeutic drugs for LUAD.

CONCLUSION:

RAMRGs serve as useful biomarkers to predict prognosis in LUAD patients, and may guide the immunotherapy regimen.

01 Apr 2026·MELANOMA RESEARCH

Determinants of adjuvant treatment choice between immunotherapy (immune checkpoint inhibitor) and targeted therapy in resected stage III BRAF V600-mutated cutaneous melanoma: a multicenter observational study: MELADJ3

Article

Author: Barbe, Coralie ; Brocard, Florence Granel ; Carlier, Claire ; Bouche, Olivier ; Didier, Kevin ; Devoldere, Aurore ; Colbach, Sixtine

In resected stage III BRAF V600-mutated melanoma, patients are eligible for adjuvant targeted therapy or immune checkpoint inhibitors (ICIs), but no comparative data guide this choice. Understanding factors shaping patient preferences is essential for shared decision-making. To identify factors associated with patient choice between adjuvant ICI or targeted therapy in resected stage III BRAF V600-mutated cutaneous melanoma. This multicenter, prospective, questionnaire-based, cross-sectional study was conducted from November 2024 to July 2025 across oncology centers in France concerning adults with completely resected AJCC8 stage III BRAF V600-mutant melanoma. Patients received standardized information from their oncologist regarding two adjuvant options – anti-PD1 immunotherapy (nivolumab or pembrolizumab) and targeted therapy (dabrafenib plus trametinib) – before making their treatment choice. The primary outcome was treatment selection (ICI vs. targeted therapy). Secondary outcomes consisted of describing determinants of patient decision-making using a structured questionnaire. Among 45 participants, 25 chose ICI and 20 selected targeted therapy. Questionnaire analysis showed that younger, professionally active patients with dependent children were more likely to prefer targeted therapy, valuing autonomy in treatment administration and reduced hospital visits. In contrast, older or nonworking patients more often favored ICI, citing reassurance from regular medical follow-up and the ability to delegate treatment management. Age and employment status were significantly associated with therapeutic choice. Identifying drivers of treatment preference may support more personalized adjuvant strategies. The finding that targeted therapy is favored by younger patients reinforces the relevance of sentinel lymph node biopsy in BRAF-mutated melanoma, despite expanding indications for immunotherapy in earlier stages.

90

News (Medical) associated with Dabrafenib Mesylate

01 Apr 2026

·www.biospace.com

Mosaic Therapeutics appoints Dr Vince O’Neill, MD, as Head of R&D

- Medical oncologist and accomplished clinical leader brings deep development and industry experience to Mosaic’s Executive Leadership team - Vince will lead research and development for Mosaic’s drug combination programs, including the build-out of the Company’s early pipeline CAMBRIDGE, England--(BUSINESS WIRE)--Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) a clinical-stage oncology therapeutics company developing next-generation, Synergistic Precision combination therapies, today announced the appointment of Dr Vince O’Neill as Head of Research and Development (R&D) to support its next phase of growth. “We are delighted to welcome Vince to the Mosaic leadership team at this pivotal stage of the company’s evolution,” said Thomas Fuchs, CEO, Mosaic Therapeutics. “His deep expertise in targeted oncology drug development and diagnostics will be instrumental as we advance our pipeline to bring transformative therapies to patients in need.” Vince is a board-certified medical oncologist and highly experienced biotechnology executive, bringing over two decades of therapeutic and diagnostic R&D experience within industry to Mosaic Therapeutics, with a track record spanning from IND through to NDA/BLA/MAA approval. Most recently he served at BioXcel Therapeutics as EVP, Head of Product Development and Chief Medical Officer, having previously held roles including Chief R&D Officer at OnkosXcel Therapeutics, and CMO roles at MIRNA Therapeutics and Exosome Diagnostics. Additionally, he has held various senior clinical development and medical leadership positions at Sanofi-Aventis, GSK, Genentech and Roche, playing an instrumental role in the development and commercialisation of multiple high-impact oncology therapeutics, including Avastin, Venclexta, Tarceva, Merkinist, and Tafinlar. In early-stage biotech, he has also secured successful public ($420M) and private ($65M series B) financing raises as part of executive leadership teams. He obtained his BSc, MD and MBChB in Medicine from the University of Glasgow. Vince O’Neill, Head of R&D, Mosaic Therapeutics, commented: “ I look forward to working closely with the Board and the team to advance our programs into the clinic and for the opportunity to develop novel combination therapies for cancer patients, utilising innovative biomarker strategies to maximise patient benefit.” About Mosaic Therapeutics Mosaic Therapeutics is an oncology therapeutics company building the category leader in Synergistic Precision Oncology. The company’s mission is to tackle cancers with substantial unmet need and few targeted treatment options, by applying its advanced experimental and computational platform to identify oncology combinations that have synergistic activity in biomarker-defined patient populations. Born out of pioneering research at the Wellcome Sanger Institute, in collaboration with the Netherlands Cancer Institute, Mosaic has active programs across a variety of oncology indications and disease biology pathways. The Company’s pipeline is anchored by ASTX295, an MDM2 antagonist, and ASTX029, an ERK1/2 inhibitor, both in-licensed from Astex Pharmaceuticals in April 2025. Mosaic’s first clinical combination study is expected to commence in early 2027. LinkedIn: Website: Contacts Thomas Fuchs CEO, Mosaic Therapeutics E: info@mosaic-tx.com

Executive Change

02 Jan 2026

·www.einpresswire.com

July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions Benlysta (belimumab) injection Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action. Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet Sarcoidosis FDA is evaluating the need for regulatory action. Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules Thrombotic microangiopathy FDA is evaluating the need for regulatory action. Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Sarcoidosis FDA is evaluating the need for regulatory action. ELEVIDYS (delandistrogene moxeparvovec-rokl) Mesenteric vein thrombosis following product-related acute liver injury The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets Drug interaction FDA is evaluating the need for regulatory action. Ifex (ifosfamide) injection Pregnancy, puerperium and perinatal conditions FDA is evaluating the need for regulatory action. Ogsiveo (nirogacestat) tablets Visual impairment FDA is evaluating the need for regulatory action. Orgovyx (relugolix) tablets Hypertension FDA is evaluating the need for regulatory action. Rezzayo (rezafungin for injection) Hypersensitivity The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis. Rezzayo labeling Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product) Wrong drug administered FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Dabrafenib Mesylate

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D10104	Dabrafenib Mesylate	L01XE23	DB08912

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
BRAF Fusion Glioma	Japan	Novartis Pharma AG	24 Sep 2024
BRAF mutation positive hairy cell leukemia	Japan	Novartis Pharma AG	24 Nov 2023
BRAF mutation Solid Tumors	Japan	Novartis Pharma AG	24 Nov 2023
High grade glioma	European Union	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Iceland	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Liechtenstein	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Norway	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	European Union	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Iceland	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Liechtenstein	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Norway	Novartis Europharm Ltd.	15 Nov 2023
BRAF V600E mutation-positive low grade glioma	United States	Novartis Pharmaceuticals Corp.	16 Mar 2023
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer	United States	Novartis Pharmaceuticals Corp.	04 May 2018
BRAF Mutation Non-small Cell Lung Cancer	Japan	Novartis Pharma AG	28 Mar 2016
BRAF mutation positive Melanoma	Japan	Novartis Pharma AG	28 Mar 2016
BRAF V600E mutant Non-small Cell Lung Cancer	South Korea	Novartis Korea Ltd.	25 Sep 2014
BRAF V600E Mutation-Positive Solid Tumors	South Korea	Novartis Korea Ltd.	25 Sep 2014
BRAF V600K Mutation-Positive Melanoma	United States	Novartis Pharmaceuticals Corp.	09 Jan 2014
Melanoma	Australia	Novartis AG	27 Aug 2013
BRAF V600 mutation-positive Melanoma	European Union	Novartis Europharm Ltd.	26 Aug 2013

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Differentiated Thyroid Gland Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	China	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Argentina	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Brazil	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Canada	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	India	Novartis Pharmaceuticals Corp.	15 Nov 2021

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_SRC2026	Not Applicable	Anaplastic Thyroid Carcinoma BRAF-mutated	44	dabrafenib+trametinib (BRAF-mutated)	vgucegdvds(hcicxsoosd) = nhbffzpwxu hrsaoaesea (ihazgnfzdo ) View more	Positive	09 Mar 2026
				ICI (Anaplastic thyroid carcinoma)	vgucegdvds(hcicxsoosd) = bnrovusajz hrsaoaesea (ihazgnfzdo ) View more
NCT02684058 (TADPOLE, Pubmed \| JCO Oncol Pract)	Phase 2	BRAF V600 mutation low-grade glioma First line BRAFV600E-Mutant	110	Dabrafenib + Trametinib	flipeutowu(ycawtoihnn) = eumvgwlzsx mlryybgvur (zcrfkouzbu )	Negative	25 Feb 2026
NCT04439292 (EAY131, Pubmed \| JCO Precis Oncol)	Phase 2	BRAF V600E Mutation-Positive Solid Tumors BRAF V600E	36	Dabrafenib 150 mg PO twice daily and Trametinib 2 mg PO once daily	cnrdhgttso(gsfkqqknos) = hhyhxsncgl brfbilmdxd (xelzsvbcpv, 22.9 - 51.2) View more	Positive	01 Jan 2026
ChiCTR2400091473 (ESMO_ASIA2025)	Phase 2	BRAF V600E	43	Dabrafenib combined with trametinib	wormizimzl(vipykjnbqo) = xlqdcmhjyz nfwkvtykgq (dgtilcvszs ) View more	Positive	05 Dec 2025
NCT04940052 (ESMO_ASIA2025)	Phase 3	BRAF V600E mutation-positive	76	Dabrafenib plus trametinib (D+T)	ktxbmxgkxm(ecoudbmajq) = The incidence of grade ≥3 AEs was higher in the D+T (52.8%) than the PBO arm (21.7%). wpdrvjgvjf (meprwkrune ) View more	Positive	05 Dec 2025
				Placebo (PBO)
ESMO_ASIA2025	Not Applicable	BRAF mutated anaplastic thyroid cancer Neoadjuvant BRAF V600E	4	Dabrafenib + Trametinib (Neoadjuvant)	ypyvvmmiaq(jdmteiykie) = remained unreached lnstnmgxqi (itftjvlqgm )	Positive	05 Dec 2025
NCT04452877 (CTgov)	Phase 2	BRAF V600E mutant Non-small Cell Lung Cancer \| BRAF V600 Mutation-Positive Non-small Cell Lung Cancer	40	Dabrafenib+Trametinib	romwrlbuao = kfsxikwuza nejwlimjvz (xisqsjijly, ozawxbowod - cczwrdqpup) View more	-	04 Nov 2025
NCT04940052 (ESMO2025)	Phase 3	Refractory Thyroid Gland Carcinoma BRAF V600E	153	Dabrafenib plus trametinib (D+T)	hceemqpvlh(weewouqoyc) = evzpyxxrxc fbnpsywtus (ffmdaoxttr ) View more	Positive	17 Oct 2025
				Placebo	hceemqpvlh(weewouqoyc) = nsvnkbvyzf fbnpsywtus (ffmdaoxttr ) View more
ESMO2025	Not Applicable	Metastatic melanoma BRAF mutations	751	Dabrafenib/trametinib	evhibxrjbd(sisghltidk) = gmjtimraah ubbowyshxe (ficnmdqxiv ) View more	Negative	17 Oct 2025
				Encorafenib/binimetinib	evhibxrjbd(sisghltidk) = rfswhsizyp ubbowyshxe (ficnmdqxiv ) View more
ESMO2025	Not Applicable	Glioblastoma BRAFV600E mutation \| NRTK-fusion	25	Dabrafenib-trametinib	mfrvklqqyb(ibibwtkkbn) = icafmsaavk wuocrhjxvv (hrbegrjoho ) View more	Positive	17 Oct 2025
				Larotrectinib	mfrvklqqyb(ibibwtkkbn) = iefpzbfmhy wuocrhjxvv (hrbegrjoho ) View more