NDAORALCAPSULE1 Generic Approved
Approved
Sep 2013
Lifecycle
Peak
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
4/8 — Partial
CYCLOPHOSPHAMIDE (cyclophosphamide) by Hikma is alkylating activity [moa]. First approved in 2013.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cyclophosphamide is an oral alkylating agent chemotherapy approved in 2013 as a capsule formulation. It works by cross-linking DNA to prevent cell division, making it effective against rapidly dividing cancer cells. The drug is used across multiple hematologic and solid tumor malignancies, often in combination regimens.
Peak
Peak-stage product with established market position but moderate competitive pressure (45/100), indicating stable but not growth-driven commercial operations.
Mechanism of Action
Alkylating Activity
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
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 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 Mar 2026
60 enrolled
Amyloidosis
A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
Started Feb 2026
26 enrolled
Multiple Myeloma
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma
Started Dec 2025
18 enrolled
B-Cell Non-Hodgkin LymphomaBurkitt LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise Specified+6 more
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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.