CDEK
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selumetinib

Trade name: Koselugo

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Apr 10, 2020

Selumetinib (INN), sold under the brand name Koselugo, is a medication for the treatment of children, two years of age and older, with neurofibromatosis type I (NF-1), a genetic disorder of the nervous system causing tumors to grow on nerves. It is taken by mouth. — Wikipedia

Clinical trial activity

124 trials · 98 clinical orgs · 1 marketing orgs

Phase 1
55
Phase 2
78
Phase 3
7
Phase 4
0

Earliest trial started Jun 1, 2004 (NCT00085787)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  2. Feb 14, 2018

    Orphan Drug Designation

2020s

  1. Apr 10, 2020

    AstraZeneca — Earliest FDA Approval

  2. Apr 10, 2020

    AstraZeneca — Marketing Organization

  3. Apr 10, 2020

    AstraZeneca — NDA Secondary Org

  4. Apr 10, 2020

    AstraZeneca — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughApr 10, 2020

Chemistry & pharmacology

Loading structure…

SMILES

Cn1cnc2c(F)c(Nc3ccc(Br)cc3Cl)c(C(=O)NOCCO)cc21.O=S(=O)(O)O
Mol. weight
555.77 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • arry142886
  • arry 142886
  • arry-142886
  • arry-142886
  • arry-142886
  • arry-142886
  • arry-886
  • arry-886
  • az6244
  • azd6244
  • azd6244
  • azd6244
  • azd 6244
  • azd-6244
  • azd-6244
  • azd-6244
  • seleumetinib
  • selumetinib
  • selumetinib
  • selumetinib
  • selumetinib
  • selumetinib
  • selumetinib sulfate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06735820Phase 1/Phase 2 (Phase 2)Apr 1, 2025Georgetown University
NCT06502171Phase 1Jan 1, 2025Department of Defense, Indiana University, University of Alabama, Birmingham, University of Pennsylvania
NCT06763315Phase 2Jan 1, 2025Sichuan University
NCT06188741Phase 2Dec 1, 2024Department of Defense, University of Alabama, Birmingham, University of Pennsylvania
NCT06621082Phase 2Sep 30, 2024Sun Yat-Sen University
NCT06620354Phase 2Sep 30, 2024Sun Yat-Sen University
NCT05825365Phase 2Aug 31, 2023AstraZeneca, Capital Medical University
NCT05253131Phase 2Apr 15, 2023Department of Defense, University of Alabama, Birmingham
NCT05554328Phase 2Dec 9, 2022National Cancer Institute (NCI), NRG Oncology
NCT05564377Phase 2Dec 9, 2022ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT05309668Phase 1/Phase 2 (Phase 2)Jan 21, 2022AstraZeneca, Merck
NCT04924608Phase 3Nov 19, 2021AstraZeneca, Merck, National Cancer Institute (NCI)
NCT05101148Phase 1Jul 21, 2021AstraZeneca, Merck
NCT04576117Phase 3Jan 8, 2021National Cancer Institute (NCI)
NCT04590235Phase 1Nov 12, 2020AstraZeneca, Jiao Tong University, Merck
NCT04495127Phase 1Aug 31, 2020AstraZeneca
NCT04348045Phase 2May 31, 2020Assistance Publique - Hôpitaux de Paris, AstraZeneca, Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
NCT04166409Phase 3Dec 2, 2019National Cancer Institute (NCI)
NCT03871257Phase 3Aug 5, 2019National Cancer Institute (NCI)
NCT03833427Phase 1Mar 18, 2019Merck
Showing 20 of 124 trials
Page 1 / 7

Organizations

Research & Development (98)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit603842006
National Cancer Institute (NCI)Government443832007
MerckFor profit8332009
IQVIAFor profit7022012
University of Texas at HoustonAcademic/Hospital7522007
Cancer Research UKAcademic/Hospital6122010
Harvard UniversityAcademic/Hospital6132009
Cornell UniversityAcademic/Hospital4132009
Department of DefenseGovernment4022018
Institut Gustave RoussyAcademic/Hospital4012009
National Institutes of Health (NIH)Government4012010
The Christie NHS Foundation TrustAcademic/Hospital4222010
University of Alabama, BirminghamAcademic/Hospital4322017
University of LondonAcademic/Hospital4322012
University of BirminghamAcademic/Hospital3212012
University of ChicagoAcademic/Hospital3122007
University of South FloridaAcademic/Hospital3012007
Canadian Cancer Trials GroupAcademic/Hospital2222013
City of Hope National Medical CenterAcademic/Hospital2012010
Fondation ARCAcademic/Hospital2012014
98 organizations
Page 1 / 5

Marketing (4)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitSYNApr 10, 2020
AstraZenecaFor profitMKTGApr 10, 2020
AstraZenecaFor profitNDA2Apr 10, 2020
AstraZenecaFor profitNDAApr 10, 2020