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Prednisolone plus Cyclophosphamide
Prednisolone plus Cyclophosphamide is a Corticosteroid + Alkylating agent combination Small molecule drug developed by Air Force Military Medical University, China. It is currently in Phase 3 development for Severe autoimmune or inflammatory conditions (specific indication not publicly detailed in available sources).
Prednisolone suppresses immune responses through glucocorticoid receptor activation, while cyclophosphamide induces immunosuppression and cytotoxicity through DNA alkylation and cross-linking.
Prednisolone suppresses immune responses through glucocorticoid receptor activation, while cyclophosphamide induces immunosuppression and cytotoxicity through DNA alkylation and cross-linking. Used for Severe autoimmune or inflammatory conditions (specific indication not publicly detailed in available sources).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Prednisolone plus Cyclophosphamide |
|---|---|
| Sponsor | Air Force Military Medical University, China |
| Drug class | Corticosteroid + Alkylating agent combination |
| Target | Glucocorticoid receptor (prednisolone); DNA (cyclophosphamide) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
This combination leverages prednisolone's broad anti-inflammatory and immunosuppressive effects via glucocorticoid signaling alongside cyclophosphamide's alkylating agent mechanism that damages rapidly dividing cells, particularly lymphocytes. Together, they provide potent immunosuppression useful in autoimmune and inflammatory conditions. The synergistic effect reduces both humoral and cellular immune responses.
Approved indications
- Severe autoimmune or inflammatory conditions (specific indication not publicly detailed in available sources)
Common side effects
- Immunosuppression / increased infection risk
- Bone marrow suppression
- Gastrointestinal disturbances
- Hyperglycemia
- Hemorrhagic cystitis (cyclophosphamide-related)
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- 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 Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) (PHASE3)
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (PHASE3)
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:
- Prednisolone plus Cyclophosphamide CI brief — competitive landscape report
- Prednisolone plus Cyclophosphamide updates RSS · CI watch RSS
- Air Force Military Medical University, China portfolio CI
Frequently asked questions about Prednisolone plus Cyclophosphamide
What is Prednisolone plus Cyclophosphamide?
How does Prednisolone plus Cyclophosphamide work?
What is Prednisolone plus Cyclophosphamide used for?
Who makes Prednisolone plus Cyclophosphamide?
What drug class is Prednisolone plus Cyclophosphamide in?
What development phase is Prednisolone plus Cyclophosphamide in?
What are the side effects of Prednisolone plus Cyclophosphamide?
What does Prednisolone plus Cyclophosphamide target?
Related
- Drug class: All Corticosteroid + Alkylating agent combination drugs
- Target: All drugs targeting Glucocorticoid receptor (prednisolone); DNA (cyclophosphamide)
- Manufacturer: Air Force Military Medical University, China — full pipeline
- Therapeutic area: All drugs in Immunology / Rheumatology
- Indication: Drugs for Severe autoimmune or inflammatory conditions (specific indication not publicly detailed in available sources)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing