FDA · United States
cyclophosphamide — FDA regulatory status
cyclophosphamide (CYCLONEX) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- CYCLONEX
- Originator
- Amdipharm Mercury (Australia) Pty Limited
- Mechanism
- DNA inhibitor
- Target
- DNA
- Structured fields
- 8
Sponsor / originator context: Amdipharm Mercury (Australia) Pty Limited. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: DNA inhibitor. Target: DNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 128 published clinical programs and 8 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 2019/2894 | Phase 3 | George Institute for | 2024-514917-36-00 |
| 20190360 | Phase 3 | Amgen | 2023-503640-14-00 |
| 54767414AMY3001 | Phase 3 | Janssen-Cilag International N.V | 2024-511967-26-00 |
| 68284528MMY3002 | Phase 3 | Janssen-Cilag International N.V | 2023-506588-32-00 |
| 68284528MMY3004 | Phase 3 | Janssen-Cilag International N.V | 2023-505850-16-00 |
| ACE-CL-311 (AMPLIFY) | Phase 3 | Anaxis Pharma | 2023-509349-11-00 |
| ALL SCTped FORUM | Phase 3 | George Institute for | 2024-512657-24-00 |
| APG2575CC301 | Phase 3 | Anaxis Pharma | 2024-514084-26-00 |
| APHP200026 | Phase 3 | PARItec | 2024-516687-28-00 |
| CA073-1003 | Phase 3 | Celgene | 2024-519152-82-00 |
| CA073-1020 | Phase 3 | Celgene | 2023-510178-15-00 |
| CA088-1007 | Phase 3 | Celgene | 2024-515279-37-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11707434 | Method for preparing organic solvent-free lyophilized cyclophosphamide | US |
| 8501678 | Variant activin receptor polypeptides and uses thereof | US |
| 8410043 | Stabilized activin IIB receptor polypeptides and uses thereof | US |
| 8309071 | Foamy viral envelope genes | US |
| 8293803 | Retinoid compounds and their use | US |
| 7183334 | Low temperature molding compositions with solid thermoplastic elastomer thickeners and fiber reinforcement | US |
| 6433037 | Method of preparing molding compositions with fiber reinforcement and products obtained therefrom | US |
| 6103779 | Method of preparing molding compositions with fiber reinforcement and products obtained therefrom | US |
Related hubs
FAQ
What is the FDA approval status of cyclophosphamide?
cyclophosphamide currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get cyclophosphamide regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to cyclophosphamide?
This spoke lists 128 published programs associated with cyclophosphamide in our pipeline index.