NDAINTRAVENOUSSOLUTION
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
CYCLOPHOSPHAMIDE (cyclophosphamide) by Dr. Reddy's Laboratories is characterized. Approved for multiple myeloma, diffuse large b-cell lymphoma, breast cancer and 3 more indications. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cyclophosphamide is a classic alkylating agent chemotherapy drug that cross-links tumor cell DNA to inhibit growth of rapidly proliferating malignant cells. It is approved for 24+ indications spanning hematologic malignancies (multiple myeloma, lymphomas, leukemias), solid tumors (breast, ovarian, pancreatic, colorectal, prostate, renal cancer), and autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis). Administered intravenously as a solution, it remains a backbone agent in combination regimens across oncology and immunology.
Peak9.1 years to LOE
Drug is at peak lifecycle stage with broad indication portfolio; stable commercial performance suggests established field infrastructure but limited growth investment.
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 (6)
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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.