CDEK
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avutometinib

Trade name: Avmapki fakzynja

Small moleculeapprovedOrphan Drug FDA

Approved

May 8, 2025

Clinical trial activity

18 trials · 23 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
12
Phase 3
1
Phase 4
0

Earliest trial started Nov 1, 2008 (NCT00773526)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2023

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2023

    Verastem, Inc. — Earliest Phase 3 Sponsor(trial)

  3. Mar 5, 2024

    Orphan Drug Designation

  4. May 8, 2025

    Earliest FDA Approval

  5. May 8, 2025

    Verastem, Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • avmapki fakzynja co-pack (copackaged)

    with defactinib

    Also known as avutometinib and defactinib

Approval history

  • approvedPriority reviewMay 8, 2025

Chemistry & pharmacology

Loading structure…

SMILES

CNS(=O)(=O)Nc1nccc(Cc2c(C)c3ccc(Oc4ncccn4)cc3oc2=O)c1F
Mol. weight
471.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • cki-27
  • cki-27
  • rg-7304
  • rg-7304
  • ro5126766
  • ro5126766
  • ro-5126766
  • ro-5126766

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07126158Phase 2Nov 30, 2025Verastem, Inc., Washington University in St. Louis
NCT06630260Phase 1/Phase 2 (Phase 2)Nov 4, 2024Cancer Research UK, Minderoo Foundation, National Health Service, United Kingdom, Royal Marsden Hospital NHS Trust, University of Cambridge, University of London, Verastem, Inc.
NCT06369259Phase 2Oct 31, 2024University of Texas at Houston
NCT06682572Phase 2Oct 30, 2024Japanese Gynecologic Oncology Group, Verastem, Inc.
NCT06487221Phase 2Oct 28, 2024Columbia University, Verastem, Inc.
NCT06495125Phase 2Jul 31, 2024Emory University, National Cancer Institute (NCI)
NCT06394804Phase 2Apr 29, 2024Memorial Sloan-Kettering Cancer Center, Verastem, Inc.
NCT06194929Phase 1/Phase 2 (Phase 2)Feb 8, 2024University of Utah, Verastem, Inc.
NCT06072781Phase 3Dec 31, 2023Australia New Zealand Gynaecological Oncology Group, European Network for Gynaecological Oncological Trial, GOG Foundation, Inc., Korean Gynecologic Oncology Group, Verastem, Inc.
NCT06104488Phase 1Oct 20, 2023Memorial Sloan-Kettering Cancer Center
NCT06007924Phase 2Aug 16, 2023Memorial Sloan-Kettering Cancer Center, Verastem, Inc.
NCT05798507Early Phase 1 (Phase 1)Jul 28, 2023Emory University, National Cancer Institute (NCI), Verastem, Inc.
NCT05787561Phase 2Mar 15, 2023Memorial Sloan-Kettering Cancer Center, Verastem, Inc.
NCT05375994Phase 1/Phase 2 (Phase 2)Aug 1, 2022Mirati Therapeutics Inc., Verastem, Inc.
NCT03681483Phase 1Sep 30, 2018Chugai, Harvard University, Memorial Sloan-Kettering Cancer Center
NCT03875820Phase 1Dec 12, 2017Chugai, University of London, Verastem, Inc.
NCT02407509Phase 1May 1, 2013Chugai, Royal Marsden Hospital NHS Trust, University of London
NCT00773526Phase 1Nov 1, 2008Roche
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Verastem, Inc.For profit12332017
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital5522018
ChugaiFor profit3012013
University of LondonAcademic/Hospital3222013
Emory UniversityAcademic/Hospital2222023
National Cancer Institute (NCI)Government2022023
Royal Marsden Hospital NHS TrustAcademic/Hospital2122013
Australia New Zealand Gynaecological Oncology GroupAcademic/Hospital1012023
Cancer Research UKAcademic/Hospital1012024
Columbia UniversityAcademic/Hospital1112024
European Network for Gynaecological Oncological TrialAcademic/Hospital1012023
GOG Foundation, Inc.Academic/Hospital1012023
Harvard UniversityAcademic/Hospital1012018
Japanese Gynecologic Oncology GroupAcademic/Hospital1012024
Korean Gynecologic Oncology GroupAcademic/Hospital1012023
Minderoo FoundationAcademic/Hospital1012024
Mirati Therapeutics Inc.For profit1012022
National Health Service, United KingdomGovernment1012024
RocheFor profit1112008
University of CambridgeAcademic/Hospital1012024
23 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
Verastem, Inc.For profitNDA2May 8, 2025