Selumetinib
Also known as Koselugo, Selumetinib sulfate
ASTRAZENECA PLC AZN · Differentiated Thyroid Cancer; Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV; Metastatic; Neurofibromatosis 1; Plexiform Neurofibroma (PN)
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
Approved
NDA213756,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Differentiated Thyroid Cancer; Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV; Metastatic; Neurofibromatosis 1; Plexiform Neurofibroma (PN) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 213756 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213756 (opens in a new tab)
- NDA 219943 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 219943 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 27 Aug 20134 linked trials
- Filed Completed
- Approved Current stageFirst approval 10 Apr 2020
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Selumetinib. Editors add each one with its source.
Filed application
No filed application is on record for Selumetinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Selumetinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04924608ClinicalTrials.gov record for NCT04924608 (opens in a new tab)KOMET | Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas | Phase 3 | Active, not recruiting | 145 (actual) | 5 Aug 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04924608 (opens in a new tab) |
Posted results on ClinicalTrials.gov for KOMET
Serious adverse events (All-cause mortality (death due to any cause) and Treatment emergent adverse events during randomised period, which is from the first dose of study intervention until the first date when selumetinib kit(s) are dispensed at Cycle 12 Day 28 (about 1 year), or 30 days after study intervention discontinuation, or up to one day prior to start of subsequent therapy, whichever occurs first. The medians of total treatment duration were 336 days for Selumetinib group and 335 days for Placebo group.): Selumetinib 25 mg/m2 10 of 71; Placebo 9 of 74 Source: ClinicalTrials.gov results for NCT04924608 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing KOMET (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT01974752ClinicalTrials.gov record for NCT01974752 (opens in a new tab)SUMIT | Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) | Phase 3 | Completed | 152 (actual) | May 2015 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01974752 (opens in a new tab) |
Posted results on ClinicalTrials.gov for SUMIT
Serious adverse events (From informed consent up until end of double blind period): Placebo + Dacarbazine 1000 mg/m2 2 of 32; Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 20 of 97 Source: ClinicalTrials.gov results for NCT01974752 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing SUMIT (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT01933932ClinicalTrials.gov record for NCT01933932 (opens in a new tab)SELECT-1 | Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC | Phase 3 | Active, not recruiting | 510 (actual) | 7 Jun 2016 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01933932 (opens in a new tab) |
Posted results on ClinicalTrials.gov for SELECT-1
Serious adverse events (AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.): Placebo + Docetaxel 82 of 254; Selumetinib + Docetaxel 124 of 251 Source: ClinicalTrials.gov results for NCT01933932 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing SELECT-1 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT01843062ClinicalTrials.gov record for NCT01843062 (opens in a new tab)ASTRA | Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer | Phase 3 | Terminated | 233 (actual) | 18 May 2018 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01843062 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ASTRA
Serious adverse events (Includes adverse events (AEs) with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of selumetinib/placebo. Overall timeframe for collection of AEs was up to 66 days from the first dose.): Selumetinib 75 mg BD + RAI 7 of 154; Placebo + RAI 0 of 77 Source: ClinicalTrials.gov results for NCT01843062 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing ASTRA (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA213756Action letter for NDA213756 (opens in a new tab) | Supplement 6 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213756Action letter for NDA213756 (opens in a new tab) | Supplement 5 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA219943Action letter for NDA219943 (opens in a new tab) | Original 1 Type 3 - New Dosage Form | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213756Action letter for NDA213756 (opens in a new tab) | Supplement 4 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213756Action letter for NDA213756 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedOrphan medicineConditional
Koselugo (EMEA/H/C/005244)
- Authorised
- Therapeutic area
- Neurofibromatosis 1
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- selumetinib
- ATC code
- L01EE04
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Koselugo (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 213756 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04924608 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT01974752 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT01933932 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT01843062 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA213756 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA219943 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.