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treosulfan

Small moleculeapprovedOrphan Drug FDA

Approved

Jan 21, 2025

Treosulfan, sold under the brand name Trecondi among others, is an alkylating medication given to people before they have a bone marrow transplant from a donor known as allogeneic hematopoietic stem cell transplantation. It is used as a 'conditioning' treatment to clear the bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells. It is used together with another medicine called fludarabine in adults and children from one month of age with blood cancers as well as in adults with other severe disorders requiring a bone marrow transplant. It belongs to the family of drugs called alkylating agents. In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells, by attaching to their DNA while they are dividing. — Wikipedia

Clinical trial activity

44 trials · 62 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
40
Phase 3
8
Phase 4
0

Earliest trial started Aug 31, 2001 (NCT00029393)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Apr 8, 2015

    Orphan Drug Designation

2020s

  1. Jan 21, 2025

    Earliest FDA Approval

  2. Jan 21, 2025

    MEDEX — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNACROSS-LINKING AGENT

    DNA cross-linking agent

Approval history

  • approvedJan 21, 2025

Chemistry & pharmacology

Loading structure…

SMILES

CS(=O)(=O)OC[C@H](O)[C@@H](O)COS(C)(=O)=O
Mol. weight
278.3 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • dihydroxybusulfan
  • dihydroxybusulfan
  • l-dihydroxybusulfan
  • l-threitol-1,4-bismethanesulfonate
  • nsc 39069
  • ovastat
  • ovastat
  • (s-(r*,r*))- 1,2,3,4-butanetetrol, 1,4-dimethanesulfonate
  • threosulphan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan
  • treosulfan, ((r*,r*)-(+-))-isomer
  • treosulfan, (r*,r*)-isomer
  • treosulfan, (r-(r*,r*))-isomer
  • treosulfan, (r*,s*)-isomer
  • treosulphan
  • tresulfan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07025824Phase 2Sep 30, 2025Medac, Technical University of Dresden
NCT06756152Phase 2/Phase 3 (Phase 3)Jul 10, 2024Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT06198842Phase 2Nov 22, 2023Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT05636787Phase 2Mar 31, 2023University Hospital "Sestre Milosrdnice", University of Bern
NCT07232953Phase 2Nov 10, 2022Spedali Civili di Brescia, University of Brescia
NCT05534620Phase 1Oct 31, 2022Medac, Synteract, Inc.
NCT04994808Phase 2Jan 1, 2022Medexus, University of Washington
NCT04965597Phase 2Dec 31, 2021Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program, University of Minnesota, University of Washington
NCT04400045Phase 2May 22, 2020Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT04195633Phase 2Jan 31, 2020Medac, University of Washington
NCT03980769Phase 2Jun 30, 2019University of Washington
NCT03434704Phase 2Jun 18, 2018Vita-Salute University of Milano. Italy
NCT02852083Phase 2Jan 1, 2016The Anticancer Fund, University of Regensburg
NCT02349906Phase 2Apr 1, 2015Celerion, Gottfried Wilhelm Leibniz Universität Hannover, INC Research, Medac, Pierrel Research
NCT02333058Phase 2Jul 1, 2014Celerion, INC Research, Medac, Sheffield Hallam University
NCT03963024Phase 1Feb 12, 2014Vita-Salute University of Milano. Italy
NCT01894477Phase 2Nov 1, 2013National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), University of Washington
NCT01772953Phase 2Sep 1, 2013Center for International Blood and Marrow Transplant Research, Medac, National Marrow Donor Program, Oregon Health and Science University, St. Baldrick's Foundation, University of Washington
NCT01949129Phase 2/Phase 3 (Phase 3)Apr 1, 2013ALL SCTped Forum, IRCCS Ospedale, Rome, Italy, Medical University of Vienna, St. Anna Kinderkrebsforschung
NCT01582048Phase 2Apr 1, 2012Medac, Neovii Biotech, Pfizer, University of Tuebingen
Showing 20 of 44 trials
Page 1 / 3

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedacFor profit15732001
University of WashingtonAcademic/Hospital9812008
National Cancer Institute (NCI)Government6012005
National Heart, Lung, and Blood Institute (NHLBI)Government5112001
Vita-Salute University of Milano. ItalyAcademic/Hospital4422005
Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyGovernment3322020
St. Anna KinderkrebsforschungAcademic/Hospital3312003
Tel Aviv UniversityAcademic/Hospital3122007
CelerionFor profit2012014
Humboldt UniversityAcademic/Hospital2122003
INC ResearchFor profit2012014
Medical University of ViennaAcademic/Hospital2012003
National Marrow Donor ProgramGovernment2012013
Oregon Health and Science UniversityAcademic/Hospital2112005
University of RegensburgAcademic/Hospital2212009
University of RostockAcademic/Hospital2012001
Akdeniz UniversityAcademic/Hospital1012007
ALL SCTped ForumAcademic/Hospital1012013
Azienda Ospedaliera San Gerardo di MonzaAcademic/Hospital1012007
Bambino Gesù Hospital and Research InstituteAcademic/Hospital1112011
62 organizations
Page 1 / 4

Marketing (1)

OrganizationOrg typeRelationshipDate
MEDEXFor profitMKTGJan 21, 2025