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IR Prednisone
IR Prednisone is a corticosteroid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.
IR Prednisone is a corticosteroid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production. Used for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis), Allergic reactions and asthma exacerbations, Adrenal insufficiency.
At a glance
| Generic name | IR Prednisone |
|---|---|
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Drug class | Corticosteroid (glucocorticoid) |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology, Rheumatology, Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Prednisone is a synthetic glucocorticoid that enters cells and binds to cytoplasmic glucocorticoid receptors, translocating to the nucleus where it modulates gene expression. This leads to decreased production of inflammatory mediators (cytokines, chemokines, adhesion molecules) and suppression of immune cell activation and proliferation. The immediate-release (IR) formulation provides rapid onset of action compared to extended-release alternatives.
Approved indications
- Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis)
- Allergic reactions and asthma exacerbations
- Adrenal insufficiency
- Certain hematologic malignancies and lymphomas
Common side effects
- Hyperglycemia
- Hypertension
- Insomnia
- Increased appetite
- Mood changes (irritability, anxiety)
- Osteoporosis (with chronic use)
- Immunosuppression / increased infection risk
- Gastrointestinal upset
Key clinical trials
- Early Use of Long-acting Tacrolimus in Lung Transplant Recipients (EARLY_PHASE1)
- A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (PHASE2)
- Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (PHASE3)
- Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout (PHASE4)
- Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout (PHASE4)
- Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis (PHASE2)
- The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
- A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE (PHASE4)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |