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ifosfamide

Trade name: ifex

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 14, 1987

Ifosfamide, sold under the brand name Ifex among others, is a chemotherapy medication used to treat a number of types of cancer. This includes testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, cervical cancer, and ovarian cancer. It is administered by injection into a vein. — Wikipedia

Clinical trial activity

439 trials · 333 clinical orgs · 11 marketing orgs

Phase 1
82
Phase 2
351
Phase 3
110
Phase 4
12

Earliest trial started Oct 1, 1986 (NCT00001209)

Timeline

1980s

  1. Jan 1, 1986

    Earliest Phase 1 Sponsor(trial)

  2. Jan 20, 1987

    Orphan Drug Designation

  3. Aug 14, 1987

    Baxter — Earliest FDA Approval

  4. Aug 14, 1987

    Baxter — NDA Organization

  5. Aug 14, 1987

    Baxalta — NDA Secondary Org

1990s

  1. Jan 1, 1990

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Feb 26, 2002

    Teva — Marketing Organization

  2. May 28, 2002

    Fresenius — Marketing Organization

  3. Apr 4, 2007

    Meitheal — Marketing Organization

  4. Apr 4, 2007

    Eu Yan Sang — Marketing Organization

2010s

  1. Jun 29, 2011

    West-Ward Pharmaceutical — Marketing Organization

  2. Jun 29, 2011

    Hikma — Marketing Organization

  3. Nov 26, 2012

    Mylan — Marketing Organization

  4. Nov 26, 2012

    Rising Pharmaceuticals — Marketing Organization

  5. Nov 26, 2012

    EXTROVIS — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNACROSS-LINKING AGENT

    DNA cross-linking agent

Combination products

  • ifex/mesnex

    with mesna

    Also known as ifosfamide/mesna

Approval history

  • approvedPriority reviewAug 14, 1987

Chemistry & pharmacology

Loading structure…

SMILES

O=P1(NCCCl)OCCCN1CCCl
Mol. weight
261.09 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warningProdrug

Sources

Also known as

  • 3-(2-chloroethyl)-2-((2-chloroethyl)amino)tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide
  • 3-(2-chloroethyl)-2-((2-chloroethyl)amino)tetrahydro-2h-1,3,2-oxazaphosphorine 2-oxide
  • holoxan
  • holoxan
  • ifex
  • ifex
  • ifex
  • ifomide
  • ifophamide
  • ifosfamid
  • ifosfamida
  • ifosfamida
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide
  • ifosfamide mustard
  • ifosfamidum
  • ifosfamidum
  • ifosfomide
  • ifosforamide mustard
  • ifosphamide
  • ifsofamide
  • ifsofamide
  • ipam
  • iphosphamide
  • iphosphamide
  • iphosphamide
  • iphosphoramide mustard
  • ipm
  • ipm
  • isoendoxan
  • isofosfamide
  • isofosfamide
  • isofosfamide
  • isophosphamide
  • isophosphamide
  • isophosphamide
  • isophosphamide
  • isophosphamide mustard
  • isophosphamide mustard
  • isophosphamide mustard
  • isophosphoramide mustard
  • isosfamide
  • isosfamide
  • mjf-9325
  • mjf-9325
  • naxamide
  • n,n'-bis-(2-chloroethyl)phosphoric acid
  • n,n'-bis-(2-chloroethyl)phosphoric acid
  • n,n'-di-(2-chloroethyl)phosphorodiamidic acid
  • palifosfamide
  • palifosfamide
  • palifosfamide
  • palifosfamide
  • palifosfamide lysine
  • palifosfamide lysine
  • palifosfamide-tris
  • z-4942
  • z-4942
  • zio201
  • zio 201
  • zio-201
  • zio-201
  • zio-201
  • zio-201-t
  • zio-201-t

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07243626Phase 2Dec 30, 2025Zhejiang University
NCT07214779Phase 3Dec 1, 2025ENGOT Foundation, GOG Foundation, Inc., Incyte
NCT07230626Phase 3Nov 20, 2025Shijiazhuang Pharma Group (CSPC)
NCT07194044Phase 1Oct 31, 2025National Pediatric Cancer Foundation, University of South Florida
NCT07152405Phase 3Sep 24, 2025Baili Pharmaceutical Group
NCT07081022Phase 2Aug 17, 2025Shanghai Junshi Bioscience Co.,Ltd.
NCT06905509Phase 2Jul 31, 2025National Cancer Institute (NCI), University of California, Davis
NCT07168980Phase 2/Phase 3 (Phase 3)Jul 1, 2025Central South University, Children's Cancer Group, China, Huazhong University of Science and Technology, Jiao Tong University, Nanjing Medical University, Shandong University, Sichuan University, Soochow University, Tianjin Medical University
NCT06835049Phase 2May 15, 2025Swiss Cancer Institute, University of Bern
NCT06820957Phase 2/Phase 3 (Phase 3)Apr 15, 2025National Cancer Institute (NCI)
NCT06849986Phase 2Feb 25, 2025Fudan University
NCT06792253Phase 3Jan 6, 2025Chinese Academy of Medical Sciences, Guangzhou BeBetter Medicine Technology Co, LTD
NCT06647953Phase 3Dec 17, 2024National Cancer Institute (NCI)
NCT06528496Phase 2Jul 22, 2024Memorial Sloan-Kettering Cancer Center
NCT06415318Phase 2Jun 1, 2024Sun Yat-Sen University
NCT06489808Phase 2May 28, 2024China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences
NCT06302465N/AMay 1, 2024Peking University
NCT06593899Phase 2May 1, 2024Fujian Medical University
NCT06239272Phase 1/Phase 2 (Phase 2)Mar 27, 2024St. Jude Children's Hospital
NCT06277154Phase 2Feb 29, 2024HRYZ Biotech Co., Sun Yat-Sen University
Showing 20 of 439 trials
Page 1 / 22

Organizations

Research & Development (333)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government1285341986
Cornell UniversityAcademic/Hospital322531990
University of Texas at HoustonAcademic/Hospital242241993
European Organisation for Research and Treatment of CancerAcademic/Hospital151131995
ZiopharmFor profit111032006
Institut Gustave RoussyAcademic/Hospital10621994
Jiao Tong UniversityAcademic/Hospital10332012
Chinese Academy of Medical SciencesAcademic/Hospital9332012
City of Hope National Medical CenterAcademic/Hospital9931994
Fudan UniversityAcademic/Hospital9832007
St. Jude Children's HospitalAcademic/Hospital9721996
UNICANCERAcademic/Hospital9721994
Peking UniversityAcademic/Hospital8642017
Sungkyunkwan UniversityAcademic/Hospital8712006
Sun Yat-Sen UniversityAcademic/Hospital8432017
University of LondonAcademic/Hospital8121995
Children's Cancer and Leukaemia GroupAcademic/Hospital7321997
Nanjing Medical UniversityAcademic/Hospital7232015
Shandong UniversityAcademic/Hospital7022015
Tianjin Medical UniversityAcademic/Hospital7122015
333 organizations
Page 1 / 17

Marketing (12)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitNDA2Aug 14, 1987
BaxterFor profitNDAAug 14, 1987
EXTROVISFor profitMKTGNov 26, 2012
Eu Yan SangFor profitMKTGApr 4, 2007
FreseniusFor profitMKTGMay 28, 2002
HikmaFor profitSYNJun 29, 2011
HikmaFor profitMKTGJun 29, 2011
MeithealFor profitMKTGApr 4, 2007
MylanFor profitMKTGNov 26, 2012
Rising PharmaceuticalsFor profitMKTGNov 26, 2012
TevaFor profitMKTGFeb 26, 2002
West-Ward PharmaceuticalFor profitMKTGJun 29, 2011