NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
CYTOXAN (cyclophosphamide) by Baxter International is characterized. First approved in 1959.
Drug data last refreshed 13h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTOXAN (cyclophosphamide) is a classic alkylating agent approved since 1959 that interferes with malignant cell growth through DNA cross-linking. It is administered via injection and used across multiple cancer indications and autoimmune conditions. The drug represents a foundational chemotherapy with broad utility in oncology and rheumatology.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling transitional commercial phase requiring defensive positioning strategies and potential team restructuring.
Mechanism of Action
characterized. However, cross-linking of tumor cell DNA may be involved. The active alkylating metabolites of cyclophosphamide interfere with the growth of susceptible rapidly proliferating malignant cells.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
Started Jan 2027
260 enrolled
Light Chain (AL) Amyloidosis
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Started Nov 2026
370 enrolled
Amyloid Light Chain (AL) Amyloidosis
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
Started Jun 2026
60 enrolled
Amyloidosis
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
Started May 2026
30 enrolled
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativeT Acute Lymphoblastic Leukemia
A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
Started Feb 2026
26 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.