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 22h ago · AI intelligence enriched 1mo 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)
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
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
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 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.