CDEK
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Revumenib

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Nov 15, 2024

Clinical trial activity

19 trials · 13 clinical orgs · 1 marketing orgs

Phase 1
13
Phase 2
8
Phase 3
2
Phase 4
0

Earliest trial started Sep 1, 2019 (NCT04065399)

Timeline

2010s

  1. Jan 1, 2019

    Syndax Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

2020s

  1. Apr 20, 2020

    Orphan Drug Designation

  2. Jan 1, 2023

    Earliest Phase 2 Sponsor(trial)

  3. Nov 15, 2024

    Syndax Pharmaceuticals — Earliest FDA Approval

  4. Nov 15, 2024

    Syndax Pharmaceuticals — NDA Organization

  5. Jan 1, 2025

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughNov 15, 2024

Chemistry & pharmacology

Loading structure…

SMILES

CCN(C(=O)c1cc(F)ccc1Oc1cncnc1N1CC2(CCN(C[C@H]3CC[C@H](NS(=O)(=O)CC)CC3)CC2)C1)C(C)C.CCN(C(=O)c1cc(F)ccc1Oc1cncnc1N1CC2(CCN(C[C@H]3CC[C@H](NS(=O)(=O)CC)CC3)CC2)C1)C(C)C.O=C(O)/C=C/C(=O)O.O=C(O)/C=C/C(=O)O.O=C(O)/C=C/C(=O)O
Mol. weight
1609.88 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07283640Phase 1May 18, 2026Amgen, Syndax Pharmaceuticals, University of Texas at Houston
NCT07211958Phase 3Dec 31, 2025Syndax Pharmaceuticals
NCT07052994Phase 1Dec 1, 2025University of Texas at Houston
NCT06652438Phase 3Feb 13, 2025German-Austrian Acute Myeloid Leukemia Study Group, HOVON - Dutch Haemato-Oncology Association, United Kingdom AML Research Network
NCT06575296Phase 1Dec 25, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06313437Phase 1Sep 30, 2024Harvard University, Syndax Pharmaceuticals
NCT06284486Phase 2Sep 23, 2024AbbVie, Syndax Pharmaceuticals, University of Texas at Houston
NCT06229912Phase 2Jul 31, 2024Syndax Pharmaceuticals, University of Texas at Houston
NCT06226571Phase 1May 21, 2024Syndax Pharmaceuticals
NCT06222580Phase 1Feb 20, 2024Ohio State University
NCT06177067Phase 1Jan 31, 2024St. Jude Children's Hospital, Syndax Pharmaceuticals
NCT05886049Phase 1Dec 19, 2023National Cancer Institute (NCI), Ohio State University
NCT05761171Phase 2Nov 20, 2023National Cancer Institute (NCI)
NCT05731947Phase 1/Phase 2 (Phase 2)Apr 4, 2023Syndax Pharmaceuticals
NCT05360160Phase 1/Phase 2 (Phase 2)Oct 14, 2022Astex Pharmaceuticals, Inc., Syndax Pharmaceuticals, University of Texas at Houston
NCT05406817Phase 1Aug 5, 2022Syndax Pharmaceuticals
NCT05326516Phase 1Mar 9, 2022Syndax Pharmaceuticals
NCT04065399Phase 1/Phase 2 (Phase 2)Sep 1, 2019Syndax Pharmaceuticals
NCT05918913N/A—Syndax Pharmaceuticals
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Syndax PharmaceuticalsFor profit13742019
University of Texas at HoustonAcademic/Hospital5522022
National Cancer Institute (NCI)Government3222023
Ohio State UniversityAcademic/Hospital2112023
AbbVieFor profit1012024
AmgenFor profit1012026
Astex Pharmaceuticals, Inc.For profit1012022
City of Hope National Medical CenterAcademic/Hospital1112024
German-Austrian Acute Myeloid Leukemia Study GroupAcademic/Hospital1012025
Harvard UniversityAcademic/Hospital1112024
HOVON - Dutch Haemato-Oncology AssociationAcademic/Hospital1112025
St. Jude Children's HospitalAcademic/Hospital1112024
United Kingdom AML Research NetworkAcademic/Hospital1012025
13 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Syndax PharmaceuticalsFor profitNDANov 15, 2024