Data updated: May 26, 2026
CYCLOPHOSPHAMIDE
Oncology
Approved 1986-07-03
CYCLOPHOSPHAMIDE 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 • Hikma
How CYCLOPHOSPHAMIDE Works
The mechanism of action of cyclophosphamide has not been fully characterized. However, its active alkylating metabolites interfere with the growth of susceptible, rapidly proliferating malignant cells, and cross-linking of tumor cell DNA may be involved in this process.
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Indications
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Phase 3 Trials
39
Years on Market
Details
- Status
- Prescription
- First Approved
- 1986-07-03
- Patent Cliff
- 2036
- Routes
- INJECTION, ORAL, INTRAVENOUS, SOLUTION
- Dosage Forms
- INJECTABLE, CAPSULE, SOLUTION, TABLET, INJECTION
Companies
Hikma EPIC PHARMA LLC Baxter XGEN PHARMS Cipla HENGRUI PHARMA ROXANE ZYDUS LIFESCIENCES ANI PHARMS AMNEAL Dr. Reddy's ALEMBIC EUGIA PHARMA SPECLTS SUNNY EIRGEN HAINAN POLY SENORES PHARMS NEXUS HETERO LABS LIMITED SAGENT PHARMS INC Novartis
Active Ingredient: CYCLOPHOSPHAMIDE
Website: ↗
CYCLOPHOSPHAMIDE Approval History
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Original
New Indication
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Label Update
141 FDA actions from 1986 to 2025
Jul 2025 SUPPL
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What CYCLOPHOSPHAMIDE Treats
10 indicationsCYCLOPHOSPHAMIDE is approved for 10 conditions since its original approval in 1986. 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
CYCLOPHOSPHAMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
10
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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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 CYCLOPHOSPHAMIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CYCLOPHOSPHAMIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CYCLOPHOSPHAMIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
1630 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 1630 trials
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Trial Timeline
Full development history with FDA approval milestones
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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.
CYCLOPHOSPHAMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)CYCLOPHOSPHAMIDE 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.
View full patent landscape →
3 OB patents · 2 families ·
25 international docs across 10 countries
CYCLOPHOSPHAMIDE Patents & Exclusivity
Latest Patent: Feb 2036
Patents (3 active)
Source: FDA Orange Book
Pro Intelligence Preview
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Revenue Insights
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Patent Timeline
- • Cliff: 2036
- • 27 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
FDA Approval: ANDA216958 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.