Selumetinib clinical trials
Selumetinib is named as an intervention in 23 current clinical trials in our Canada, USA, Spain, France, Italy, Netherlands, Mexico, China, UK, Poland, Japan, Germany, Australia, Israel, Sweden, Brazil, South Korea, Denmark, Egypt, Belgium, Austria, Portugal, Turkey, Taiwan and Norway registers. 3 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is AstraZeneca (9). The most-studied condition is Neurofibromatosis Type 1.
Where Selumetinib is approved
All regulators →Of the three regulators tracked here, the first to approve Selumetinib was the US, on 10 Apr 2020. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of amyotrophic lateral sclerosis (13 Dec 2023, 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.
Selumetinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Selumetinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 26 Mar 2029 (US 12364684).
- Latest patent on the drug substance itself: 13 Mar 2028 (US 7425637).
- Exclusivity ODE-545: Orphan drug exclusivity: treatment of adult patients with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofi…, until 19 Nov 2032.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 19 Nov 2032.
- Exclusivity NPP: New patient population, until 19 Nov 2028.
- Exclusivity NPP: New patient population, until 10 Sep 2028.
- Exclusivity NP: New product, until 10 Sep 2028.
- Exclusivity ODE-288: Orphan drug exclusivity: indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (nf1) who…, until 10 Apr 2027.
- 1 further exclusivities are listed.
- Koselugo for treatment of neurofibromatosis type 1: until 19 Jun 2033 (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 Selumetinib
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 Selumetinib works
All drug targets →- Dual specificity mitogen-activated protein kinase kinase 1 inhibitor InhibitorTarget: MAP2K1 mitogen-activated protein kinase kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Dual specificity mitogen-activated protein kinase kinase 2 inhibitor InhibitorTarget: MAP2K2 mitogen-activated protein kinase kinase 2ChEMBL only
- Low grade gliomaPhase 3
- MelanomaPhase 3
- Non-small cell lung carcinomaPhase 3
- Optic pathway gliomaPhase 3
- Thyroid cancerPhase 3
- Uveal melanomaPhase 3
- Acoustic neuromaPhase 2
- Acute myeloid leukemiaPhase 2
- Bile duct cancerPhase 2
- Biliary tract cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1614701, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5665, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Selumetinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KoselugoEMA product information: package leaflet and summary of product characteristics in every EU language.
- 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 Selumetinib
- ChEMBL
- CHEMBL1614701
- DrugBank
- DB11689
- PubChem CID
- 10127622
- CAS number
- 606143-52-6
- FDA UNII
- 6UH91I579U
- Wikidata
- Q7448840
- Wikipedia
- Selumetinib
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 Selumetinib
23 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.
Selumetinib 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)
4 single-substance products containing Selumetinib on the HPRA medicines list.
- Koselugo 10 mg hard capsulesAstraZeneca AB · EU/1/21/1552/001
- Koselugo 25 mg hard capsulesAstraZeneca AB · EU/1/21/1552/002
- Koselugo 5 mg granules in capsule for openingAstraZeneca AB · EU/1/21/1552/003
- Koselugo 7.5 mg granules in capsule for openingAstraZeneca AB · EU/1/21/1552/004
Supply shortages
No entry for Selumetinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Selumetinib
43 conditionsAll 43 conditions
| Condition (as registered) | Trials |
|---|---|
| Neurofibromatosis Type 1 | 3 |
| Neurofibromatosis 1 | 2 |
| Neurofibromatosis Type 2 | 2 |
| Meningioma | 2 |
| Low Grade Glioma | 2 |
| Advanced Malignant Solid Neoplasm | 2 |
| Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV | 1 |
| Plexiform Neurofibroma (PN) | 1 |
| Muscle Invasive Bladder Cancer | 1 |
| Advanced Non Small Cell Lung Cancer | 1 |
| Non-Small Cell Lung Cancer | 1 |
| NF2 | 1 |
| NF2-related Schwannomatosis | 1 |
| Neurofibroma Plexiform | 1 |
| Vestibular Schwannoma | 1 |
| Non-vestibular Schwannoma | 1 |
| Plexiform Neurofibromas (PN) | 1 |
| Pediatric Cancer | 1 |
| Metastatic Pancreatic Adenocarcinoma | 1 |
| Metastatic Breast Cancer | 1 |
| Biliary Tract Carcinoma | 1 |
| Gallbladder Carcinoma | 1 |
| Non-small Cell Lung Cancer | 1 |
| Tumor | 1 |
| Cancer | 1 |
| Recurrent Low Grade Astrocytoma | 1 |
| Recurrent WHO Grade 2 Glioma | 1 |
| Refractory Low Grade Astrocytoma | 1 |
| Refractory Low Grade Glioma | 1 |
| Low Grade Astrocytoma | 1 |
| Metastatic Low Grade Astrocytoma | 1 |
| Metastatic Low Grade Glioma | 1 |
| Visual Pathway Glioma | 1 |
| Ann Arbor Stage III Non-Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IV Non-Hodgkin Lymphoma | 1 |
| Histiocytic Sarcoma | 1 |
| Recurrent Endometrial Carcinoma | 1 |
| Recurrent Fallopian Tube Carcinoma | 1 |
| Recurrent Ovarian Carcinoma | 1 |
| Recurrent Primary Peritoneal Carcinoma | 1 |
| Anatomic Stage III Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IV Breast Cancer AJCC v8 | 1 |
| Locally Advanced Malignant Solid Neoplasm | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Selumetinib trials
How many clinical trials are testing Selumetinib?
23 current trials in our Canada, USA, Spain, France, Italy, Netherlands, Mexico, China, UK, Poland, Japan, Germany, Australia, Israel, Sweden, Brazil, South Korea, Denmark, Egypt, Belgium, Austria, Portugal, Turkey, Taiwan and Norway registers name Selumetinib (also registered as AZD6244) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Selumetinib trials recruiting patients?
Yes. 3 of the 23 trials are recruiting: 1 with sites in Canada, 1 with sites in Spain, 1 with sites in France, 1 with sites in Italy, 1 with sites in Netherlands, 1 with sites in Mexico, 1 with sites in Israel, 1 with sites in Denmark and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Selumetinib clinical trials?
AstraZeneca (9), National Cancer Institute (NCI) (6), Beijing Tiantan Hospital (2) and West China Hospital (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Selumetinib licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Selumetinib, for example Koselugo 10 mg hard capsules (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Selumetinib shortage?
Not in the lists we track: Selumetinib 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 Selumetinib 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 Selumetinib 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 Selumetinib (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 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.