CDEK
← All drugs Report issue

cyclophosphamide

Trade name: cytoxan

Small moleculeapproved

Approved

Nov 16, 1959

Cyclophosphamide (CP), also known as cytophosphane among other names, is a medication used as chemotherapy and to suppress the immune system. As chemotherapy it is used to treat lymphoma, multiple myeloma, leukemia, ovarian cancer, breast cancer, small cell lung cancer, neuroblastoma, and sarcoma. As an immune suppressor it is used in nephrotic syndrome, ANCA-associated vasculitis, and following organ transplant, among other conditions. It is taken by mouth or injection into a vein. — Wikipedia

Clinical trial activity

3,851 trials · 1,289 clinical orgs · 37 marketing orgs

Phase 1
1130
Phase 2
2779
Phase 3
782
Phase 4
89

Earliest trial started Feb 1, 1976 (NCT00001155)

Timeline

1950s

  1. Nov 16, 1959

    Baxalta — Earliest FDA Approval

  2. Nov 16, 1959

    Baxalta — NDA Organization

  3. Nov 16, 1959

    Baxalta — NDA Secondary Org

  4. Nov 16, 1959

    Baxter — NDA Secondary Org

1970s

  1. Jan 1, 1976

    Earliest Phase 2 Sponsor(trial)

1980s

  1. Feb 16, 1982

    Bedford Pharmaceuticals — Marketing Organization

  2. Jan 1, 1986

    Earliest Phase 1 Sponsor(trial)

  3. Jul 3, 1986

    Baxter — Marketing Organization

  4. Jan 1, 1988

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Apr 29, 1993

    Teva — Marketing Organization

  2. Aug 17, 1999

    Roxane Laboratories — Marketing Organization

  3. Aug 17, 1999

    Boehringer Ingelheim — Marketing Organization

2010s

  1. Sep 16, 2013

    West-Ward Pharmaceutical — NDA Secondary Org

  2. Sep 16, 2013

    Hikma — Marketing Organization

  3. Sep 16, 2013

    Hikma — NDA Secondary Org

  4. Oct 31, 2014

    Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. — Marketing Organization

  5. Oct 31, 2014

    Hengrui Therapeutics, Inc. — Marketing Organization

  6. Mar 19, 2018

    Ani Pharmaceuticals — Marketing Organization

  7. Mar 19, 2018

    Amerigen Pharmaceuticals — Marketing Organization

  8. May 7, 2018

    STI Pharma, LLC — Marketing Organization

  9. May 7, 2018

    Animas Corporation — Marketing Organization

  10. May 7, 2018

    Johnson and Johnson — Marketing Organization

  11. May 7, 2018

    Senores Pharms — Marketing Organization

  12. May 25, 2018

    Amneal Pharmaceuticals — Marketing Organization

  13. Jan 18, 2019

    Cipla — Marketing Organization

2020s

  1. Jul 30, 2020

    Ingenus Pharmaceuticals — Marketing Organization

  2. Jul 30, 2020

    Ingenus Pharmaceuticals — NDA Secondary Org

  3. Aug 25, 2021

    Eugia Pharma — Marketing Organization

  4. Aug 25, 2021

    Auromedics Pharma — Marketing Organization

  5. Aug 25, 2021

    Eugia Pharma — NDA Secondary Org

  6. Oct 18, 2022

    X Gen Pharmaceuticals — Marketing Organization

  7. Nov 10, 2022

    Alembic — Marketing Organization

  8. Jun 7, 2023

    Dr. Reddy's Laboratories — Marketing Organization

  9. Jun 7, 2023

    Dr. Reddy's Laboratories — NDA Secondary Org

  10. Jun 7, 2023

    AVYXA HOLDINGS — Marketing Organization

  11. Jun 27, 2023

    Nevakar, LLC — Marketing Organization

  12. Jun 27, 2023

    Nevakar, LLC — NDA Secondary Org

  13. Jun 27, 2023

    Baxalta — Marketing Organization

  14. Jul 17, 2023

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  15. Jul 17, 2023

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  16. Sep 12, 2023

    Sandoz — Marketing Organization

  17. Oct 26, 2023

    Sunny Pharmtech Inc — Marketing Organization

  18. Dec 13, 2023

    Zydus Discovery DMCC — Marketing Organization

  19. Dec 18, 2023

    Apicore — Marketing Organization

  20. Oct 29, 2024

    Nexus Pharmaceuticals — Marketing Organization

  21. Dec 3, 2024

    Opko — Marketing Organization

  22. Dec 19, 2024

    Epic Pharma Llc — Marketing Organization

  23. Dec 26, 2024

    Hainan Poly Pharm — Marketing Organization

  24. Jan 20, 2026

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedPriority reviewNov 16, 1959

Chemistry & pharmacology

Loading structure…

SMILES

O=P1(N(CCCl)CCCl)NCCCO1
Mol. weight
261.09 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Prodrug

Sources

Also known as

  • 2-[bis(2-chloroethylamino)]-tetrahydro-2h-1,3,2-oxazaphosphorine-2-oxide
  • 2-[bis(2-chloroethylamino)]-tetrahydro-2h-1,3,2-oxazaphosphorine-2-oxide
  • a-4828
  • a-4828
  • anhydrous cyclophosphamide
  • anhydrous cyclophosphamide
  • bis(2-chloroethyl)phosphoramide cyclic propanolamide ester
  • bis(2-chloroethyl)phosphoramide cyclic propanolamide ester
  • ciclofosfamida
  • ciclofosfamida
  • ciclofosfamida
  • ciclofosfamide
  • ciclofosfamide
  • cyc
  • cyclophosphamid
  • cyclophosphamid
  • cyclophosphamid
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • cyclophosphamide
  • (+-)-cyclophosphamide
  • (+-)-cyclophosphamide
  • cyclophosphamide anhydrous
  • cyclophosphamide anhydrous
  • cyclophosphamide hydrate
  • cyclophosphamide hydrate
  • cyclophosphamide hydrate
  • cyclophosphamidum
  • cyclophosphamidum
  • cyclophosphamidum
  • cyclophosphan
  • cyclophosphane
  • cyclophosphomide
  • cycolophosphamide
  • cytophosphan
  • cytophosphan
  • cytophosphan
  • cytophosphane
  • cytophosphane
  • cytoxan
  • cytoxan
  • cytoxan
  • cytoxan
  • cytoxan (lyophilized)
  • cytoxin
  • endoxan
  • endoxan
  • endoxana
  • endoxana
  • genoxal trofosfamida
  • gm-csf
  • horse thymoglobulin
  • ixoten
  • ixoten
  • ledoxina
  • ledoxina
  • lyophilized cytoxan
  • lyophilized cytoxan
  • mitoxan
  • neosar
  • neosar
  • neosar
  • n,n-3'-tris(2-chloroethyl)tetrahydro-2h-1,3,2-oxazaphosphorin-2-amine, 2-oxide
  • n,n-bis(2-chloroethyl)tetrahydro-2h-1,3,2-oxazaphosphorin-2-amine 2-oxide
  • n,n-bis(2-chloroethyl)tetrahydro-2h-1,3,2-oxazaphosphorin-2-amine 2-oxide
  • n,n,n'-tris(2-chloroethyl)-n'-o-propylene phosphoric acid ester diamide
  • panc 10.05 pcdna-1/gm-neo
  • panc 6.03 pcdna-1 neo
  • (rs)-cyclophosphamide
  • (rs)-cyclophosphamide
  • tetwtcea dna
  • trifosfamide
  • trilofosfamida
  • trilophosphamide
  • triphosphamide
  • trisfosfamide
  • trofosfamid
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trofosfamide
  • trophosphamid
  • trophosphamide
  • trophosphamide
  • trophosphamide
  • trophosphamide
  • z 4828
  • z-4828
  • z-4828

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06996119Phase 1May 25, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07220187Phase 3May 2, 2026National Cancer Institute (NCI), SWOG Cancer Research Network
NCT07224100Phase 2May 1, 2026Takeda, University of Washington
NCT07227571Phase 1May 1, 2026University of Washington
NCT07228624Phase 2May 1, 2026Incyte, University of Washington
NCT07227584Phase 2Apr 30, 2026Harvard University
NCT07278856Phase 1Apr 27, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07300475Phase 1Mar 31, 2026Washington University in St. Louis
NCT07072585Phase 2/Phase 3 (Phase 3)Mar 30, 2026National Cancer Institute (NCI)
NCT07294677Phase 1/Phase 2 (Phase 2)Mar 17, 2026University of Chicago
NCT07199413Phase 1Mar 1, 2026Medical College of Wisconsin
NCT07164469Phase 2Feb 28, 2026Bellicum Pharmaceuticals, University of Texas at Houston
NCT07137481Phase 2Feb 28, 2026University of Texas at Houston
NCT07304154Phase 1Jan 31, 2026Gilead Sciences
NCT07297667Phase 1Jan 31, 2026Canadian Cancer Trials Group, University of Calgary
NCT07157514Phase 2/Phase 3 (Phase 3)Jan 31, 2026Actinium Pharmaceuticals
NCT07288073Phase 2Jan 31, 2026Harvard University, Iovance
NCT07297914Phase 2/Phase 3 (Phase 3)Jan 15, 2026Bambino Gesù Hospital and Research Institute
NCT07231250Phase 2Jan 15, 2026Sun Yat-Sen University
NCT06815003Phase 2Jan 8, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
Showing 20 of 3,851 trials
Page 1 / 193

Organizations

Research & Development (1,289)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government89333541986
University of Texas at HoustonAcademic/Hospital18617641991
University of WashingtonAcademic/Hospital12911441990
Johns Hopkins UniversityAcademic/Hospital917841994
RocheFor profit885451999
University of MinnesotaAcademic/Hospital878241995
Cornell UniversityAcademic/Hospital847341990
Harvard UniversityAcademic/Hospital826241994
Sun Yat-Sen UniversityAcademic/Hospital825552006
St. Jude Children's HospitalAcademic/Hospital746941991
Jiao Tong UniversityAcademic/Hospital685052009
City of Hope National Medical CenterAcademic/Hospital665741994
National Institutes of Health (NIH)Government661341992
Chinese Academy of Medical SciencesAcademic/Hospital604152008
Fudan UniversityAcademic/Hospital594342003
Baylor UniversityAcademic/Hospital564931994
GenentechFor profit56741998
Southwest Oncology GroupAcademic/Hospital523431989
CelgeneFor profit511231998
Mayo ClinicAcademic/Hospital503241989
1,289 organizations
Page 1 / 65

Marketing (51)

OrganizationOrg typeRelationshipDate
AVYXA HOLDINGSFor profitMKTGJun 7, 2023
AlembicFor profitMKTGNov 10, 2022
Amerigen PharmaceuticalsFor profitMKTGMar 19, 2018
Amneal PharmaceuticalsFor profitMKTGMay 25, 2018
Amneal PharmaceuticalsFor profitSYNMay 25, 2018
Ani PharmaceuticalsFor profitMKTGMar 19, 2018
Ani PharmaceuticalsFor profitSYNMar 19, 2018
Animas CorporationFor profitMKTGMay 7, 2018
ApicoreFor profitMKTGDec 18, 2023
Auromedics PharmaFor profitMKTGAug 25, 2021
BaxaltaFor profitNDANov 16, 1959
BaxaltaFor profitNDA2Nov 16, 1959
BaxaltaFor profitMKTGJun 27, 2023
BaxterFor profitNDA2Nov 16, 1959
BaxterFor profitMKTGJul 3, 1986
Bedford PharmaceuticalsFor profitMKTGFeb 16, 1982
Boehringer IngelheimFor profitMKTGAug 17, 1999
CiplaFor profitMKTGJan 18, 2019
Dr. Reddy's LaboratoriesFor profitMKTGJun 7, 2023
Dr. Reddy's LaboratoriesFor profitNDA2Jun 7, 2023
Epic Pharma LlcFor profitMKTGDec 19, 2024
Eugia PharmaFor profitMKTGAug 25, 2021
Eugia PharmaFor profitNDA2Aug 25, 2021
Hainan Poly PharmFor profitMKTGDec 26, 2024
Hengrui Therapeutics, Inc.For profitMKTGOct 31, 2014
Hengrui Therapeutics, Inc.For profitSYNOct 31, 2014
Hetero Labs LtdFor profitMKTGJan 20, 2026
HikmaFor profitMKTGSep 16, 2013
HikmaFor profitSYNSep 16, 2013
HikmaFor profitNDA2Sep 16, 2013
Ingenus PharmaceuticalsFor profitMKTGJul 30, 2020
Ingenus PharmaceuticalsFor profitNDA2Jul 30, 2020
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.For profitMKTGOct 31, 2014
Johnson and JohnsonFor profitMKTGMay 7, 2018
Nevakar, LLCFor profitMKTGJun 27, 2023
Nevakar, LLCFor profitNDA2Jun 27, 2023
Nexus PharmaceuticalsFor profitMKTGOct 29, 2024
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGJul 17, 2023
OpkoFor profitMKTGDec 3, 2024
Roxane LaboratoriesFor profitMKTGAug 17, 1999
STI Pharma, LLCFor profitMKTGMay 7, 2018
Sagent Pharmaceuticals, Inc.For profitMKTGJul 17, 2023
SandozFor profitMKTGSep 12, 2023
SandozFor profitSYNSep 12, 2023
Senores PharmsFor profitMKTGMay 7, 2018
Sunny Pharmtech IncFor profitMKTGOct 26, 2023
TevaFor profitMKTGApr 29, 1993
West-Ward PharmaceuticalFor profitNDA2Sep 16, 2013
X Gen PharmaceuticalsFor profitMKTGOct 18, 2022
Zydus Discovery DMCCFor profitMKTGDec 13, 2023
Zydus Discovery DMCCFor profitSYNDec 13, 2023