NDAINTRAVENOUSSOLUTION
Approved
Jun 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
FRINDOVYX (cyclophosphamide) by Viatris (2) is characterized. First approved in 2023.
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FRINDOVYX (cyclophosphamide) is an intravenous alkylating agent approved in June 2023 that works by cross-linking tumor cell DNA to interfere with rapidly proliferating malignant cells. It is a small-molecule chemotherapy with a well-established mechanism of action in oncology. The product is indicated for treatment of various malignancies where cyclophosphamide is the standard of care.
Peak9.3 years to LOE
Peak-stage product with established market presence offers stability for commercial teams, though market size and growth trajectory require further investigation.
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
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.