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dordaviprone

Trade name: Modeyso

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 6, 2025

Clinical trial activity

30 trials · 26 clinical orgs · 0 marketing orgs

Phase 1
15
Phase 2
18
Phase 3
2
Phase 4
0

Earliest trial started Jan 14, 2014 (NCT02038699)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jun 4, 2018

    Orphan Drug Designation

2020s

  1. Jan 1, 2022

    Earliest Phase 3 Sponsor(trial)

  2. Aug 6, 2025

    Earliest FDA Approval

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 6, 2025

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccccc1CN1C(=O)C2=C(CCN(Cc3ccccc3)C2)N2CCN=C12
Mol. weight
386.5 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

  • onc201
  • onc201
  • onc201
  • onc-201
  • tic10 compound
  • trail-inducing compound 10

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06012929Phase 1Jan 31, 2024Chimerix, University of Nebraska
NCT05630794Phase 1May 13, 2023National Cancer Institute (NCI), Rhode Island Hospital
NCT05542407Phase 1Dec 15, 2022Genentech, Oncoceutics, Inc., University of North Carolina at Chapel Hill
NCT05580562Phase 3Dec 1, 2022Chimerix
NCT05476939Phase 3Sep 29, 2022Chimerix, Innovative Therapies For Children with Cancer Consortium, Institut Gustave Roussy
NCT05009992Phase 2Oct 20, 2021Mithil Prasad Foundation, Storm the Heavens Fund, The Chad-Tough Defeat DIPG Foundation, University of California, San Francisco
NCT04854044Phase 1May 1, 2021National Cancer Institute (NCI), Oncoceutics, Inc., University of California, Los Angeles
NCT04629209Phase 2Dec 15, 2020Oncoceutics, Inc.
NCT04055649Phase 2Sep 11, 2019Wayne State University
NCT03932643Phase 1Jul 31, 2019University of Nebraska
NCT03791398Phase 1/Phase 2 (Phase 2)Jun 30, 2019Bristol-Myers Squibb, Brown University, Oncoceutics, Inc., Rhode Island Hospital
NCT03733119Phase 2Nov 13, 2018University of Wisconsin, V Foundation
NCT03492138Phase 1/Phase 2 (Phase 2)Mar 26, 2018Icahn School of Medicine at Mount Sinai
NCT03485729Phase 2Mar 21, 2018Oncoceutics, Inc.
NCT03416530Phase 1Jan 29, 2018Oncoceutics, Inc.
NCT03394027Phase 2Jan 17, 2018National Cancer Institute (NCI)
NCT03295396Phase 2Oct 31, 2017Oncoceutics, Inc.
NCT03099499Phase 2Jun 30, 2017Oncoceutics, Inc., Temple University
NCT03134131N/AApr 20, 2017Oncoceutics, Inc.
NCT03034200Phase 2Feb 1, 2017Case Western Reserve University, University of Rochester
Showing 20 of 30 trials
Page 1 / 2

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Oncoceutics, Inc.For profit16932014
National Cancer Institute (NCI)Government5222015
ChimerixFor profit4232022
Rhode Island HospitalAcademic/Hospital2022019
Rutgers UniversityAcademic/Hospital2212015
Temple UniversityAcademic/Hospital2222015
University of NebraskaAcademic/Hospital2212019
University of Texas at HoustonAcademic/Hospital2212015
Bristol-Myers SquibbFor profit1012019
Brown UniversityAcademic/Hospital1112019
Case Western Reserve UniversityAcademic/Hospital1112017
GenentechFor profit1012022
Harvard UniversityAcademic/Hospital1012014
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112018
Innovative Therapies For Children with Cancer ConsortiumAcademic/Hospital1012022
Institut Gustave RoussyAcademic/Hospital1112022
Mithil Prasad FoundationAcademic/Hospital1012021
Storm the Heavens FundAcademic/Hospital1012021
The Chad-Tough Defeat DIPG FoundationAcademic/Hospital1012021
University of California, Los AngelesAcademic/Hospital1112021
26 organizations
Page 1 / 2