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Cyclophosphamide and steroids
Cyclophosphamide and steroids is a Alkylating agent + corticosteroid combination Small molecule drug developed by Radboud University Medical Center. It is currently in Phase 3 development for Autoimmune conditions (e.g., vasculitis, lupus nephritis), Hematologic malignancies, Severe systemic autoimmune diseases. Also known as: prednisolone, endoxan.
Cyclophosphamide is an alkylating chemotherapy agent that damages DNA to kill rapidly dividing cells, while steroids suppress immune responses and reduce inflammation.
Cyclophosphamide is an alkylating chemotherapy agent that damages DNA to kill rapidly dividing cells, while steroids suppress immune responses and reduce inflammation. Used for Autoimmune conditions (e.g., vasculitis, lupus nephritis), Hematologic malignancies, Severe systemic autoimmune diseases.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cyclophosphamide and steroids |
|---|---|
| Also known as | prednisolone, endoxan |
| Sponsor | Radboud University Medical Center |
| Drug class | Alkylating agent + corticosteroid combination |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology, Hematology |
| Phase | Phase 3 |
Mechanism of action
Cyclophosphamide works by cross-linking DNA strands, preventing cell division and inducing apoptosis in malignant and autoreactive cells. Steroids (typically corticosteroids) enhance this effect by suppressing T-cell and B-cell function, reducing inflammatory cytokine production, and providing immunosuppression. This combination is used to target both malignant proliferation and pathogenic immune responses in autoimmune and hematologic conditions.
Approved indications
- Autoimmune conditions (e.g., vasculitis, lupus nephritis)
- Hematologic malignancies
- Severe systemic autoimmune diseases
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Infection
- Hemorrhagic cystitis
- Nausea and vomiting
- Immunosuppression-related complications
- Secondary malignancy
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cyclophosphamide and steroids CI brief — competitive landscape report
- Cyclophosphamide and steroids updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI
Frequently asked questions about Cyclophosphamide and steroids
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Related
- Drug class: All Alkylating agent + corticosteroid combination drugs
- Manufacturer: Radboud University Medical Center — full pipeline
- Therapeutic area: All drugs in Oncology, Immunology, Hematology
- Indication: Drugs for Autoimmune conditions (e.g., vasculitis, lupus nephritis)
- Indication: Drugs for Hematologic malignancies
- Indication: Drugs for Severe systemic autoimmune diseases
- Also known as: prednisolone, endoxan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing