TheraRadar
Data updated: May 26, 2026

CYTOXAN (cyclophosphamide)

Trial Activity: Stable 7 active trials
Oncology Approved 1959-11-16

CYTOXAN is indicated for the treatment of Hodgkin's Disease; Lymphocytic Lymphoma; Mixed-Cell Type Lymphoma; Histiocytic Lymphoma; Burkitt's Lymphoma; Multiple Myeloma; Leukemia; Mycosis Fungoides; Neuroblastoma; Adenocarcinoma of Ovary.

Source: FDA Label • Baxter
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CYTOXAN Works

The mechanism of action is not fully characterized; however, cyclophosphamide is converted into active alkylating metabolites that interfere with the growth of susceptible, rapidly proliferating malignant cells. These metabolites are thought to work by cross-linking tumor cell DNA, thereby disrupting cellular replication.

Source: FDA Label

Development Insights

Baylor College of Medicine conducting 6 trials (35%)
32 indications explored (Broad Platform)
→ neuroblastoma (3 trials)
→ hepatocellular carcinoma (2 trials)
→ human papillomavirus-related carcinoma (1 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
66
Years on Market

Details

Status
Prescription
First Approved
1959-11-16
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE

Companies

Baxter
Active Ingredient: CYCLOPHOSPHAMIDE

CYTOXAN Approval History

1960
1961
1962
1963
1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
234 FDA actions from 1959 to 2024
Sep 2024 SUPPL
Label · Labeling
FDA Letter Label
Aug 2020 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter
Oct 2016 SUPPL
Mfg · Manufacturing (CMC)

What CYTOXAN Treats

10 indications

CYTOXAN is approved for 10 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hodgkin's Disease
  • Lymphocytic Lymphoma
  • Mixed-Cell Type Lymphoma
  • Histiocytic Lymphoma
  • Burkitt's Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Mycosis Fungoides
Source: FDA Label

CYTOXAN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

LOMUSTINE
CARNEGIE
2025 2 indic.
TEPYLUTE
SHORLA
2024 2 indic.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

KYXATA
AVYXA HOLDINGS
2025 1 indic.
ZUSDURI
UROGEN PHARMA
2025 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

OZILTUS
AMNEAL PHARMS
2025 4 indic.
BLENREP
GSK
2025 1 indic.
Unlock 24 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in CYTOXAN's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CYTOXAN treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to CYTOXAN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
10 shared
Hikma
Shared indications:
Hodgkin's DiseaseLymphocytic LymphomaMixed-Cell Type Lymphoma +7 more
FRINDOVYX
CYCLOPHOSPHAMIDE
9 shared
AVYXA HOLDINGS
Shared indications:
Hodgkin's DiseaseLymphocytic LymphomaMixed-Cell Type Lymphoma +6 more
VINCRISTINE SULFATE PFS
VINCRISTINE SULFATE
2 shared
Pfizer
Shared indications:
Hodgkin's DiseaseNeuroblastoma
View all 20 similar drugs Pro
📋

Clinical Trial Registry

1646 trials
Trial Sponsor ID Phase Status Title
NCT06058377 NCI-2023-04566 NCI-2023-04566, S2206 Ph 3 recruiting Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
NCT04759586 NCI-2021-01071 NCI-2021-01071, ANHL1931 Ph 3 active not recruiting Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
NCT06172296 NCI-2023-08530 NCI-2023-08530, ANBL2131 Ph 3 recruiting Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT04530565 NCI-2020-06381 NCI-2020-06381, EA9181 Ph 3 active not recruiting Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT07328503 10001986 001986-C Ph 2 recruiting CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
NCT06528691 GLOBOTRK NCI-2024-02977 Ph 2 recruiting Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
NCT04301076 NCI-2020-01535 NCI-2020-01535, 10335 Ph 1 suspended Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
NCT06615479 CA088-1007 Ph 3 recruiting A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
NCT06124157 NCI-2023-09214 NCI-2023-09214, AALL2131 Ph 2 recruiting A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT03520647 180090 18-H-0090 Ph 2 recruiting Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
NCT05675410 NCI-2022-10845 NCI-2022-10845, AHOD2131 Ph 3 recruiting A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
NCT07583303 25704 NCI-2026-02922, 25704 Ph 1 not yet recruiting BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation
NCT06904066 10002088 002088-C Ph 1 recruiting Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
NCT04539366 NCI-2020-06646 NCI-2020-06646, PED-CITN-02 Ph 1 suspended Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial
NCT07572136 10001555 001555-C Ph 1 not yet recruiting Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
NCT06698744 CASE1A24 Ph 1 withdrawn UF-KURE-BCMA CAR-T Cells in Patients With Relapsed or Refractory Multiple Myeloma
NCT04093596 UNIVERSAL ALLO-715-101 Ph 1 completed Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
NCT02629120 160032 16-I-0032 Ph 1, Ph 2 active not recruiting High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease
NCT02133196 140104 14-C-0104 Ph 2 recruiting T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
NCT03808610 2016-0629 NCI-2018-03360, 2016-0629 Ph 1, Ph 2 terminated Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia
NCT03984448 NCI-2019-03711 NCI-2019-03711, A051701 Ph 2, Ph 3 active not recruiting Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
NCT03269669 NCI-2017-00009 NCI-2017-00009, S1608 Ph 2 active not recruiting Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
NCT06066359 2023-0171 NCI-2023-08318 Ph 1, Ph 2 recruiting Ph I/II Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR/IL-15 for R/R Myeloma
NCT07444710 NCI-2026-01137 NCI-2026-01137, PHI-158 Ph 1 not yet recruiting Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
NCT07509034 10001973 001973-C Ph 1 not yet recruiting Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
NCT04799275 NCI-2020-01256 NCI-2020-01256, S1918 Ph 2, Ph 3 active not recruiting Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
NCT06317662 NCI-2024-01994 NCI-2024-01994, AALL2321 Ph 2 recruiting Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
NCT07524530 10002233 002233-C Ph 2 not yet recruiting Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
NCT06738368 RG1124788 NCI-2024-09417, FHIRB0020869 Ph 2 recruiting Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia
NCT06897930 D8313C00001 Ph 1, Ph 2 recruiting A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
NCT07479797 KT-US-740-0603 2025-524403-80-00 Ph 3 recruiting Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
NCT07297667 I246 Ph 1 not yet recruiting GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
NCT07526493 QH10310-NADs-01（0） Ph 1 recruiting Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
NCT05088356 IRB-60439 NCI-2021-12228 Ph 1 active not recruiting Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
NCT02308527 BEACON RG_11-087 2012-000072-42 Ph 2 completed Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
NCT05492682 VALO-001 2021-002529-13 Ph 1 recruiting START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
NCT05020444 20-518 Ph 1 recruiting TriPRIL CAR T Cells in Multiple Myeloma
NCT03286634 ASIA-DS-ALL-2016 Ph 2 active not recruiting ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
NCT07257419 HAPALL NCI-2025-08364 Ph 1 recruiting CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
NCT05453500 RG1122464 NCI-2022-05225, 11008 Ph 2 active not recruiting Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
NCT06996119 23822 NCI-2025-03603, 23822 Ph 1 recruiting Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
NCT04145349 results posted 17305 J1S-MC-JV01, 2018-004242-42 Ph 1, Ph 2 completed CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor
NCT00871013 108053 Ph 2 active not recruiting Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy
NCT04923893 CARTITUDE-5 CR109015 68284528MMY3004, 2021-001242-35 Ph 3 active not recruiting A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
NCT06253520 10001662 001662-C Ph 1 active not recruiting Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer
NCT03150693 A041501 NCI-2016-01981, U10CA180821 Ph 3 recruiting Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
NCT01174121 100166 10-C-0166 Ph 2 recruiting Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
NCT03412877 180049 18-C-0049 Ph 2 recruiting Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
NCT02621021 160027 16-C-0027 Ph 2 recruiting A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
NCT06577025 aMMbition 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 Ph 2 active not recruiting A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Showing 50 of 1646 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CYTOXAN FDA Label Details

Indications & Usage

FDA Label (PDF)

CYTOXAN is indicated for the treatment of Hodgkin's Disease; Lymphocytic Lymphoma; Mixed-Cell Type Lymphoma; Histiocytic Lymphoma; Burkitt's Lymphoma; Multiple Myeloma; Leukemia; Mycosis Fungoides; Neuroblastoma; Adenocarcinoma of Ovary.

Track CYTOXAN with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA012141 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment