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olutasidenib

Trade name: Rezlidhia

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 1, 2022

Clinical trial activity

15 trials · 13 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
12
Phase 3
0
Phase 4
0

Earliest trial started Apr 1, 2016 (NCT02719574)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Apr 27, 2017

    Orphan Drug Designation

2020s

  1. Dec 1, 2022

    Rigel Pharmaceuticals — Earliest FDA Approval

  2. Dec 1, 2022

    Rigel Pharmaceuticals — Marketing Organization

  3. Dec 1, 2022

    Rigel Pharmaceuticals — NDA Secondary Org

  4. Dec 1, 2022

    Rigel Pharmaceuticals — NDA Organization

  5. Jan 1, 2024

    Rigel Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 1, 2022

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](Nc1ccc(C#N)n(C)c1=O)c1cc2cc(Cl)ccc2[nH]c1=O
Mol. weight
354.8 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • ft-2102

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07153497Phase 2Feb 26, 2026National Cancer Institute (NCI)
NCT07304011Phase 2Jan 17, 2026National Cancer Institute (NCI), University of California, Davis
NCT07130695Phase 1Oct 31, 2025Rigel Pharmaceuticals, Virginia Commonwealth University
NCT07032727Phase 2Sep 12, 2025Rigel Pharmaceuticals, University of Texas at Houston
NCT06782542Phase 2Apr 1, 2025Rigel Pharmaceuticals, University of Miami
NCT06597734Phase 2Mar 11, 2025Rigel Pharmaceuticals, University of Texas at Houston
NCT06566742Phase 2Feb 28, 2025Rigel Pharmaceuticals, University of Texas at Houston
NCT06668584Phase 1/Phase 2 (Phase 2)Dec 31, 2024University of Texas at Houston
NCT06543381Phase 1Dec 15, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06705530Phase 1/Phase 2 (Phase 2)Nov 26, 2024Russian Academy of Medical Sciences
NCT06445959Phase 1/Phase 2 (Phase 2)Aug 29, 2024University of Texas at Houston
NCT06161974Phase 2Jun 15, 2024Ohio State University, Rigel Pharmaceuticals, University of Pennsylvania
NCT04013880Phase 1/Phase 2 (Phase 2)Aug 31, 2019Astex Pharmaceuticals, Inc., Forma Therapeutics, Inc., Vanderbilt University
NCT03684811Phase 1/Phase 2 (Phase 2)Oct 1, 2018Forma Therapeutics, Inc.
NCT02719574Phase 1Apr 1, 2016Forma Therapeutics, Inc.
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Rigel PharmaceuticalsFor profit6122024
University of Texas at HoustonAcademic/Hospital5512024
Forma Therapeutics, Inc.For profit3222016
National Cancer Institute (NCI)Government3122024
Astex Pharmaceuticals, Inc.For profit1012019
City of Hope National Medical CenterAcademic/Hospital1112024
Ohio State UniversityAcademic/Hospital1112024
Russian Academy of Medical SciencesAcademic/Hospital1112024
University of California, DavisAcademic/Hospital1112026
University of MiamiAcademic/Hospital1112025
University of PennsylvaniaAcademic/Hospital1012024
Vanderbilt UniversityAcademic/Hospital1112019
Virginia Commonwealth UniversityAcademic/Hospital1112025
13 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Rigel PharmaceuticalsFor profitMKTGDec 1, 2022
Rigel PharmaceuticalsFor profitNDA2Dec 1, 2022
Rigel PharmaceuticalsFor profitNDADec 1, 2022