Dabrafenib clinical trials
Dabrafenib is named as an intervention in 26 current clinical trials in our China, Israel, USA, Norway, Mexico, France, Netherlands, Denmark, Canada, Germany, Spain, Italy, Czechia, Brazil, Japan, Australia, Egypt, UK, Belgium, Sweden, India, Turkey, South Korea, Taiwan and Austria registers. 14 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (4). The most-studied condition is Melanoma. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Dabrafenib is approved
All regulators →Of the three regulators tracked here, the first to approve Dabrafenib was the US, on 29 May 2013. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of glioma (9 Dec 2020, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Dabrafenib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Dabrafenib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 29 Dec 2038 (US 11504333, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 15 Apr 2031 (US 8703781, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 16 Sep 2030.
- Exclusivity ODE-428: Orphan drug exclusivity: treatment of pediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who…, until 16 Mar 2030.
- Finlee for treatment of glioma: until 16 Nov 2035 (includes 24 months' paediatric extension). Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Dabrafenib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Dabrafenib works
All drug targets →- Serine/threonine-protein kinase B-raf inhibitor InhibitorTarget: BRAF B-Raf proto-oncogene, serine/threonine kinase✓ In ChEMBL and the Guide to Pharmacology
- AmeloblastomaPhase 3
- Cutaneous melanomaPhase 3
- Differentiated thyroid carcinomaPhase 3
- Soft tissue sarcomaPhase 3
- Thyroid cancerPhase 3
- Erdheim-Chester diseasePhase 2
- Langerhans cell histiocytosisPhase 2
- Papillary CraniopharyngiomaPhase 2
- Acral lentiginous melanomaPhase 2
- Anaplastic gangliogliomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2028663, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6494, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Dabrafenib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Dabrafenib. 4 are current, and 4 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over NICE TA977 | Recommended | 29 May 2024 | Current |
| Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer NICE TA898 | Optimised | 14 Jun 2023 | Current |
| Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma NICE TA544 | Recommended | 17 Oct 2018 | Current |
| Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma NICE TA321 | Recommended | 22 Oct 2014 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Dabrafenib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Dabrafenib
- ATC code
- L01XE23
- ChEMBL
- CHEMBL2028663
- DrugBank
- DB08912
- PubChem CID
- 44462760
- CAS number
- 1195765-45-7
- FDA UNII
- QGP4HA4G1B
- Wikidata
- Q3011604
- Wikipedia
- Dabrafenib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Dabrafenib
26 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Dabrafenib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Dabrafenib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Dabrafenib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Dabrafenib on the HPRA medicines list.
- Finlee 10 mg dispersible tabletsNovartis Europharm Limited · EU/1/23/1767/001-002
- Tafinlar 50 mg hard capsulesNovartis Europharm Limited · EU/1/13/865/001-002
- Tafinlar 75 mg hard capsulesNovartis Europharm Limited · EU/1/13/865/003-004
Supply shortages
No entry for Dabrafenib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Dabrafenib
54 conditionsAll 54 conditions
| Condition (as registered) | Trials |
|---|---|
| Melanoma | 4 |
| Anaplastic Astrocytoma | 2 |
| Solid Tumor | 2 |
| Metastatic Melanoma | 2 |
| Diffuse Astrocytoma | 1 |
| Astrocytoma | 1 |
| Oligodendroglioma, Childhood | 1 |
| Advanced Solid Tumor | 1 |
| Pancreatic Adenocarcinoma | 1 |
| Malignant Melanoma (Cutaneous) | 1 |
| Non-small Cell Lung Cancer (NSCLC) | 1 |
| Differentiated Thyroid Cancer (DTC) | 1 |
| Non Small Cell Lung Cancer | 1 |
| Rare Cancers | 1 |
| BRAF V600E | 1 |
| Colorectal Cancer | 1 |
| Sintilimab | 1 |
| MSS (Microsatellite Stable) | 1 |
| Lung Cancer Stage III | 1 |
| Mutation | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Precision Medicine | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| Langerhans Cell Histiocytosis (LCH) | 1 |
| Thyroid Neoplasms | 1 |
| Ameloblastoma | 1 |
| BRAF V600E Mutation Positive | 1 |
| NSCLC | 1 |
| BRAF V600 Mutation | 1 |
| MET Exon 14 Mutation | 1 |
| Malignant Solid Tumor | 1 |
| Fertility | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Malignant Melanoma | 1 |
| Rare Malignant Neoplasm | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Multiple Myeloma | 1 |
| Advanced Solid Tumors | 1 |
| Advanced Lymphoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Stage III Cutaneous Melanoma AJCC v7 | 1 |
| Stage IV Cutaneous Melanoma AJCC v6 and v7 | 1 |
| Unresectable Melanoma | 1 |
| Anaplastic Astrocytoma, Not Otherwise Specified | 1 |
| Anaplastic Ganglioglioma | 1 |
| Anaplastic Pleomorphic Xanthoastrocytoma | 1 |
| Clinical Stage III Cutaneous Melanoma AJCC v8 | 1 |
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | 1 |
| Recurrent Melanoma | 1 |
Sponsors
lead sponsor per trial+ 4 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Dabrafenib trials
How many clinical trials are testing Dabrafenib?
26 current trials in our China, Israel, USA, Norway, Mexico, France, Netherlands, Denmark, Canada, Germany, Spain, Italy, Czechia, Brazil, Japan, Australia, Egypt, UK, Belgium, Sweden, India, Turkey, South Korea, Taiwan and Austria registers name Dabrafenib (also registered as DRB436) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Dabrafenib trials recruiting patients?
Yes. 14 of the 26 trials are recruiting: 8 with sites in China, 1 with sites in USA, 2 with sites in Norway, 1 with sites in Mexico, 2 with sites in France, 2 with sites in Netherlands, 2 with sites in Denmark, 1 with sites in Canada, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Czechia, 1 with sites in Japan and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Dabrafenib clinical trials?
Novartis Pharmaceuticals (4), National Cancer Institute (NCI) (4), Sun Yat-sen University (2) and Immuneering Corporation (1), among 19 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Dabrafenib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Dabrafenib, for example Finlee 10 mg dispersible tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Dabrafenib shortage?
Not in the lists we track: Dabrafenib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Dabrafenib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Dabrafenib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Dabrafenib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.