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MMF and Dexamethasone
MMF and Dexamethasone is a Immunosuppressant combination Small molecule drug developed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is currently in Phase 3 development for Kidney disease (likely IgA nephropathy or lupus nephritis based on NIDDK involvement).
MMF (mycophenolate mofetil) suppresses T and B cell proliferation while dexamethasone provides broad immunosuppression and anti-inflammatory effects.
MMF (mycophenolate mofetil) suppresses T and B cell proliferation while dexamethasone provides broad immunosuppression and anti-inflammatory effects. Used for Kidney disease (likely IgA nephropathy or lupus nephritis based on NIDDK involvement).
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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 | MMF and Dexamethasone |
|---|---|
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Drug class | Immunosuppressant combination |
| Target | IMPDH (mycophenolate); glucocorticoid receptor (dexamethasone) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase (IMPDH), selectively depleting guanosine nucleotides needed for lymphocyte proliferation. Dexamethasone is a corticosteroid that suppresses immune cell activation and reduces inflammatory cytokine production. Together, this combination provides potent immunosuppression for conditions requiring immune modulation.
Approved indications
- Kidney disease (likely IgA nephropathy or lupus nephritis based on NIDDK involvement)
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
- Infection risk
- Leukopenia
- Steroid-related effects (hyperglycemia, hypertension, osteoporosis)
Key clinical trials
- The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment (PHASE2)
- A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT) (PHASE2)
- Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia (PHASE1)
- Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL (PHASE2, PHASE3)
- Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies (EARLY_PHASE1)
- Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR (PHASE2, PHASE3)
- Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders (PHASE2)
- Assessment of Rituximab Therapeutic Response Versus Conventional Treatment (PHASE2, 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:
- MMF and Dexamethasone CI brief — competitive landscape report
- MMF and Dexamethasone updates RSS · CI watch RSS
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) portfolio CI
Frequently asked questions about MMF and Dexamethasone
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Related
- Drug class: All Immunosuppressant combination drugs
- Target: All drugs targeting IMPDH (mycophenolate); glucocorticoid receptor (dexamethasone)
- Manufacturer: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Kidney disease (likely IgA nephropathy or lupus nephritis based on NIDDK involvement)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing