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Cytoxan (Lyophilized) (CYCLOPHOSPHAMIDE)
Cytoxan works by interfering with the DNA replication process in rapidly dividing cancer cells.
Cytoxan (Lyophilized) is a cyclophosphamide-based chemotherapy medication originally developed by Baxter Healthcare. It is a small molecule that targets the cytochrome P450 3A4 enzyme and has been FDA-approved since 1959 for various types of leukemia and cancer, including adenocarcinoma of the ovary and breast cancer. As an off-patent medication, it is available from multiple generic manufacturers. Key safety considerations include its potential for bone marrow suppression and other hematologic toxicities. Commercially, it is available in a lyophilized form.
At a glance
| Generic name | CYCLOPHOSPHAMIDE |
|---|---|
| Sponsor | Baxter |
| Drug class | cyclophosphamide |
| Target | Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1959 |
Mechanism of action
The mechanism of action is thought to involve cross-linking of tumor cell DNA.
Approved indications
- Acute lymphoid leukemia, disease
- Acute monocytic leukemia
- Acute myelogenous leukemia
- Adenocarcinoma of the ovary
- Burkitt's lymphoma
- Carcinoma of breast
- Chronic lymphoid leukemia, disease
- Chronic myeloid leukemia
- Histiocytic lymphoma
- Hodgkin's disease
- Malignant lymphoma
- Mixedcell type lymphoma
- Multiple myeloma
- Mycosis fungoides
- Neuroblastoma
- Retinoblastoma
- Systemic AL amyloidosis
- Treatment prior to tumor-specific T-cell infusion therapy
Common side effects
- Nausea and vomiting
- Leukopenia
- Alopecia
- Anorexia
- Abdominal discomfort or pain
- Diarrhea
- Thrombocytopenia or anemia
- Hemorrhagic colitis
- Oral mucosal ulceration
- Jaundice
- Skin rash
- Pigmentation of the skin
Drug interactions
- fluconazole
- itraconazole
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
- 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 (PHASE2)
- Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL (PHASE1,PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12329767 | 2036-02-15 | Formulation |
| 10993952 | 2036-02-15 | Formulation |
| 9662342 | 2035-06-26 | Formulation |
| 10849916 | 2035-07-13 | Formulation |
| 11382923 | 2035-12-01 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cytoxan (Lyophilized) CI brief — competitive landscape report
- Cytoxan (Lyophilized) updates RSS · CI watch RSS
- Baxter portfolio CI