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busulfan

Trade name: Myleran

Small moleculeapproved

Approved

Jun 26, 1954

Busulfan is a chemotherapy drug in use since 1959. It is a cell cycle non-specific alkylating antineoplastic agent, in the class of alkyl sulfonates. Its chemical designation is 1,4-butanediol dimethanesulfonate. — Wikipedia

Clinical trial activity

549 trials · 252 clinical orgs · 26 marketing orgs

Phase 1
129
Phase 2
403
Phase 3
77
Phase 4
7

Earliest trial started Aug 1, 1987 (NCT00002547)

Timeline

1950s

  1. Jun 26, 1954

    Aspen Pharmaceuticals — Earliest FDA Approval

  2. Jun 26, 1954

    Aspen Pharmaceuticals — NDA Secondary Org

  3. Jun 26, 1954

    Aspen Pharmaceuticals — NDA Organization

  4. Jun 26, 1954

    Woodward — Marketing Organization

  5. Jun 26, 1954

    Woodward — NDA Secondary Org

  6. Jun 26, 1954

    Waylis Therap — Marketing Organization

1980s

  1. Jan 1, 1987

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jan 1, 1991

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  3. Feb 4, 1999

    Otsuka — NDA Secondary Org

2010s

  1. Dec 22, 2015

    Lutipold — Marketing Organization

  2. Dec 22, 2015

    Sankyo — Marketing Organization

  3. Dec 22, 2015

    Daiichi Sankyo — Marketing Organization

  4. Mar 24, 2017

    Pharmasciences — Marketing Organization

  5. Mar 24, 2017

    Ferring — Marketing Organization

  6. Nov 20, 2017

    Aspen Pharmaceuticals — Marketing Organization

  7. Dec 8, 2017

    Actavis — Marketing Organization

  8. Dec 8, 2017

    Allergan PLC (2015) — Marketing Organization

  9. Dec 18, 2017

    Amneal Pharmaceuticals — Marketing Organization

  10. Jul 13, 2018

    Mylan — Marketing Organization

  11. Jul 13, 2018

    PHARMOBEDIENT — Marketing Organization

  12. Jul 31, 2018

    Hospira — Marketing Organization

  13. Jul 31, 2018

    Pfizer — Marketing Organization

  14. Sep 21, 2018

    Athenex, Inc. — Marketing Organization

  15. Sep 21, 2018

    Salarius Pharmaceuticals, LLC — Marketing Organization

  16. Jan 14, 2019

    Nexus Pharmaceuticals — Marketing Organization

  17. Feb 22, 2019

    Accord Research — Marketing Organization

  18. Apr 18, 2019

    Shilpa Medicare Ltd. — Marketing Organization

  19. May 7, 2019

    Apotex — Marketing Organization

2020s

  1. Oct 23, 2020

    Nanjing King-Friend — Marketing Organization

  2. Oct 23, 2020

    Meitheal — Marketing Organization

  3. Jun 25, 2024

    Eugia Pharma — Marketing Organization

  4. Sep 11, 2024

    Prinston Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNACROSS-LINKING AGENT

    DNA cross-linking agent

Approval history

  • approvedPriority reviewJun 26, 1954

Chemistry & pharmacology

Loading structure…

SMILES

CS(=O)(=O)OCCCCOS(C)(=O)=O
Mol. weight
246.302 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 1,4-bis(methanesulfonoxy)butane
  • 1,4-bis(methanesulfonoxy)butane
  • 1,4-butanediol dimethanesulfonate
  • 1,4-butanediol dimethanesulfonate
  • 1,4-dimesyloxybutane
  • 1,4-dimesyloxybutane
  • 1,4-dimethanesulfonoxybutane
  • 1,4-dimethanesulfonoxybutane
  • bisulfex
  • bisulfex
  • busilvex
  • busilvex
  • busilvex
  • busilvex
  • busilvex
  • busilvex
  • busilvex
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfan
  • busulfano
  • busulfano
  • busulfano
  • busulfanum
  • busulfanum
  • busulfex
  • busulfex
  • busulfex
  • busulfex
  • busulphan
  • busulphan
  • busulphan
  • citosulfan
  • glyzophrol
  • leucosulfan
  • leucosulfan
  • leucosulfan
  • mablin
  • mablin
  • mannitol busulfan
  • mielucin
  • mielucin
  • misulban
  • misulban
  • mitostan
  • mitostan
  • myeloleukon
  • myeloleukon
  • myelosan
  • myelosan
  • myleran
  • myleran
  • myleran
  • myleran
  • sulphabutin
  • sulphabutin
  • sulphabutin
  • tetramethylene bis(methanesulfonate)
  • tetramethylene bis(methanesulfonate)
  • zinc finger nuclease ccr5-modified hematopoietic stem cells

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06996119Phase 1May 25, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07228624Phase 2May 1, 2026Incyte, University of Washington
NCT06954987Phase 2Dec 18, 2025National Cancer Institute (NCI)
NCT07113743Phase 1/Phase 2 (Phase 2)Sep 10, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT07085156Phase 2Aug 1, 2025Huazhong University of Science and Technology, Jiao Tong University, Zhejiang University
NCT06959771Phase 1/Phase 2 (Phase 2)Jul 16, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT07052422Phase 2/Phase 3 (Phase 3)Jul 15, 2025Southern Medical University
NCT06869265Phase 2May 1, 2025Peking University
NCT06851767Phase 1/Phase 2 (Phase 2)Mar 20, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT06802315Phase 2Feb 4, 2025University of Illinois at Chicago
NCT06816134Phase 2Jan 30, 2025Soochow University
NCT06758726N/ADec 31, 2024China Academy of Chinese Medical Sciences
NCT06506461Phase 1Dec 31, 2024St. Jude Children's Hospital
NCT06872333Phase 2Nov 19, 2024University of Minnesota
NCT06345495Phase 2Oct 1, 2024Incyte, University of Texas at Houston
NCT06613035Phase 3Sep 30, 2024China Academy of Chinese Medical Sciences
NCT06337331Phase 2Aug 31, 2024Northside Hospital, Inc.
NCT06252870Phase 2Jul 18, 2024University of Angers, University of Nantes, University of Western Brittany
NCT06207799Phase 2Jul 17, 2024Pfizer, University of Texas at Houston
NCT06297772Phase 3Jun 1, 2024Jiao Tong University
Showing 20 of 549 trials
Page 1 / 28

Organizations

Research & Development (252)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government1372541987
University of Texas at HoustonAcademic/Hospital575441994
University of WashingtonAcademic/Hospital353041993
University of MinnesotaAcademic/Hospital343441995
Jiao Tong UniversityAcademic/Hospital201942011
Peking UniversityAcademic/Hospital16532016
Harvard UniversityAcademic/Hospital15922000
Southern Medical UniversityAcademic/Hospital151512016
Sun Yat-Sen UniversityAcademic/Hospital15122016
National Institute of Allergy and Infectious Diseases (NIAID)Government141422001
St. Jude Children's HospitalAcademic/Hospital141241991
City of Hope National Medical CenterAcademic/Hospital131231999
National Heart, Lung, and Blood Institute (NHLBI)Government13231998
OtsukaFor profit13232008
University of California, San FranciscoAcademic/Hospital131131996
Case Western Reserve UniversityAcademic/Hospital111031988
Columbia UniversityAcademic/Hospital11921996
Cornell UniversityAcademic/Hospital111021992
Northwestern UniversityAcademic/Hospital111021999
Center for International Blood and Marrow Transplant ResearchGovernment10432010
252 organizations
Page 1 / 13

Marketing (36)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 22, 2019
ActavisFor profitMKTGDec 8, 2017
ActavisFor profitSYNDec 8, 2017
Allergan PLC (2015)For profitMKTGDec 8, 2017
Amneal PharmaceuticalsFor profitMKTGDec 18, 2017
Amneal PharmaceuticalsFor profitSYNDec 18, 2017
ApotexFor profitSYNMay 7, 2019
ApotexFor profitMKTGMay 7, 2019
Aspen PharmaceuticalsFor profitNDA2Jun 26, 1954
Aspen PharmaceuticalsFor profitNDAJun 26, 1954
Aspen PharmaceuticalsFor profitMKTGNov 20, 2017
Athenex, Inc.For profitMKTGSep 21, 2018
Daiichi SankyoFor profitMKTGDec 22, 2015
Eugia PharmaFor profitMKTGJun 25, 2024
FerringFor profitMKTGMar 24, 2017
HospiraFor profitMKTGJul 31, 2018
HospiraFor profitSYNJul 31, 2018
LutipoldFor profitMKTGDec 22, 2015
MeithealFor profitMKTGOct 23, 2020
MylanFor profitSYNNov 20, 2017
MylanFor profitMKTGJul 13, 2018
Nanjing King-FriendFor profitMKTGOct 23, 2020
Nexus PharmaceuticalsFor profitMKTGJan 14, 2019
Nexus PharmaceuticalsFor profitSYNJan 14, 2019
OtsukaFor profitNDA2Feb 4, 1999
PHARMOBEDIENTFor profitMKTGJul 13, 2018
PfizerFor profitMKTGJul 31, 2018
PharmasciencesFor profitMKTGMar 24, 2017
Prinston IncFor profitMKTGSep 11, 2024
Salarius Pharmaceuticals, LLCFor profitMKTGSep 21, 2018
SankyoFor profitMKTGDec 22, 2015
Shilpa Medicare Ltd.For profitMKTGApr 18, 2019
Shilpa Medicare Ltd.For profitMKTGApr 18, 2019
Waylis TherapFor profitMKTGJun 26, 1954
WoodwardFor profitMKTGJun 26, 1954
WoodwardFor profitNDA2Jun 26, 1954