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MR prednisone
MR prednisone is a Corticosteroid (modified-release) Small molecule drug developed by Amgen. It is currently in Phase 3 development for Rheumatoid arthritis, Other inflammatory and autoimmune conditions (specific indication in Phase 3 trial not publicly confirmed).
MR prednisone is a modified-release formulation of the corticosteroid prednisone that provides delayed and prolonged release to optimize anti-inflammatory and immunosuppressive effects.
MR prednisone is a modified-release formulation of the corticosteroid prednisone that provides delayed and prolonged release to optimize anti-inflammatory and immunosuppressive effects. Used for Rheumatoid arthritis, Other inflammatory and autoimmune conditions (specific indication in Phase 3 trial not publicly confirmed).
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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. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | MR prednisone |
|---|---|
| Sponsor | Amgen |
| Drug class | Corticosteroid (modified-release) |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology / Inflammation |
| Phase | Phase 3 |
Mechanism of action
Prednisone is a glucocorticoid that binds to glucocorticoid receptors in the cytoplasm, translocates to the nucleus, and modulates gene expression to suppress inflammatory cytokines, reduce immune cell activation, and decrease inflammatory mediator production. The modified-release formulation is designed to deliver the drug at specific times or rates to improve efficacy, reduce side effects, or enhance patient compliance compared to immediate-release formulations.
Approved indications
- Rheumatoid arthritis
- Other inflammatory and autoimmune conditions (specific indication in Phase 3 trial not publicly confirmed)
Common side effects
- Insomnia
- Increased appetite
- Mood changes
- Hyperglycemia
- Hypertension
- Osteoporosis (with chronic use)
- Immunosuppression / increased infection risk
Key clinical trials
- 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)
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer (PHASE1, PHASE2)
- Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma (PHASE2)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (PHASE2)
- Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (PHASE3)
- Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body (PHASE3)
- Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (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:
- MR prednisone CI brief — competitive landscape report
- MR prednisone updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about MR prednisone
What is MR prednisone?
How does MR prednisone work?
What is MR prednisone used for?
Who makes MR prednisone?
What drug class is MR prednisone in?
What development phase is MR prednisone in?
What are the side effects of MR prednisone?
What does MR prednisone target?
Related
- Drug class: All Corticosteroid (modified-release) drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Immunology / Rheumatology / Inflammation
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Other inflammatory and autoimmune conditions (specific indication in Phase 3 trial not publicly confirmed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing