SOLU-MEDROL (methylprednisolone sodium succinate)
SOLU-MEDROL is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Serum Sickness; Transfusion Reaction; Bullous Dermatitis Herpetiformis; Exfoliative Erythroderma; Mycosis Fungoides; Pemphigus.
How SOLU-MEDROL Works
Methylprednisolone is a synthetic glucocorticoid with potent anti-inflammatory and immunosuppressive properties. It diffuses across cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This receptor-ligand complex translocates into the cell nucleus, where it binds to glucocorticoid response elements (GREs) on DNA, altering gene transcription. This leads to the inhibition of pro-inflammatory cytokine synthesis (such as IL-1, IL-6, and TNF-alpha) and the induction of lipocortins. Lipocortins inhibit phospholipase A2, thereby decreasing the release of arachidonic acid and the subsequent synthesis of inflammatory mediators like prostaglandins and leukotrienes. At the cellular level, it also reduces the extravasation of leukocytes to inflammatory sites and suppresses the immune response by reducing lymphatic system activity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1959-05-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SOLU-MEDROL Approval History
What SOLU-MEDROL Treats
10 indicationsSOLU-MEDROL is approved for 10 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Atopic Dermatitis
- Contact Dermatitis
- Drug Hypersensitivity
- Serum Sickness
- Transfusion Reaction
- Bullous Dermatitis Herpetiformis
- Exfoliative Erythroderma
SOLU-MEDROL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SOLU-MEDROL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SOLU-MEDROL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SOLU-MEDROL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07054801 LIMSAH | 23-40755 | Ph 2 | not yet recruiting | IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage |
| NCT06360458 MIRACLE | MRCTA,ECFAH of FMU[2024]368-1 | Ph 3 | active not recruiting | Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke |
| NCT06462781 LIGHT 1 | 23-267 | Ph 1 | completed | Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1 |
| NCT07202143 MIRACLE-2 | MRCTA, ECFAH of FMU [2025]887 | Ph 3 | recruiting | Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia |
| NCT07185633 | 20250824101854977 | Ph 2 | not yet recruiting | Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease |
| NCT01319981 results posted | 2008-0598 NCI-2011-00861 | Ph 2 | completed | Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia |
| NCT04377503 | covid-19 hsd | Ph 2 | terminated | Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19 |
| NCT02464657 results posted | 2014-0907 NCI-2015-01258 | Ph 1, Ph 2 | completed | Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) |
| NCT04343729 MetCOVID | CAEE: 30615920.2.0000.0005 | Ph 2 | completed | Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
| NCT03082092 | PISTKR | Ph 4 | completed | Pre-operative Intravenous Steroid in Total Knee Replacement for Pain Relief and Recovery |
| NCT02425813 | IRB00032434 NCI-2015-00548, CCCWFU 98115 | Ph 2 | withdrawn | Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract |
| NCT01977781 results posted | 13-067H | Ph 1 | completed | Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease |
| NCT02317601 | 2014-002492-29 2014-002492-29 | Ph 4 | completed | Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOLU-MEDROL FDA Label Details
Indications & Usage
FDA Label (PDF)SOLU-MEDROL is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Serum Sickness; Transfusion Reaction; Bullous Dermatitis Herpetiformis; Exfoliative Erythroderma; Mycosis Fungoides; Pemphigus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment