Methylprednisolone: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Methylprednisolone appears in the FDA drug-label database. Marketed as MethylPREDNISolone.
- Drug class
- Corticosteroid (FDA established pharmacologic class)
- Mechanism of action
- Corticosteroid Hormone Receptor Agonists (as stated on the FDA label)
FDA-approved use
Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndro…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. — Zydus Pharmaceuticals USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-05-06 |
| Subpotent; 6 month stability time point — American Health Packaging | Class III (FDA: unlikely to cause harm) | Terminated | 2014-10-10 |
| Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol. — Hikma Pharmaceuticals USA Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-01-14 |
| CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. — Zydus Pharmaceuticals USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-05-06 |
| Subpotent; 6 month stability time point — Qualitest Pharmaceuticals | Class III (FDA: unlikely to cause harm) | Terminated | 2014-09-11 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Crohn Disease | 2 |
| Crohn's disease | 2 |
| Multiple Sclerosis | 2 |
| Asthma | 1 |
| Asthma (Diagnosis) | 1 |
| Heart failure | 1 |
| Lupus | 1 |
| Lupus Nephritis | 1 |
| Myocarditis Acute | 1 |
| Optic Neuritis | 1 |
Recruiting trials involving Methylprednisolone
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
- Autologous Stem Cell Transplant for Crohn's Disease
- Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
- MYTHS - MYocarditis THerapy With Steroids
- Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
- Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
- Stem Cell Transplantation in Crohn's Disease
Common questions
Is Methylprednisolone FDA-approved?
Yes, marketed as MethylPREDNISolone.
How many recruiting trials involve Methylprednisolone?
7 recruiting trials across 10 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.