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Prelone (prednisolone)
Prednisolone is the active form of prednisone, approved in 1955 and available generically. Preferred over prednisone in liver impairment and pediatric patients. Available in oral, ophthalmic, and injectable formulations.
At a glance
| Generic name | prednisolone |
|---|---|
| Also known as | Prelone, Orapred, Pediapred |
| Sponsor | Generic (originally Schering) |
| Drug class | Glucocorticoid (corticosteroid) |
| Target | Annexin A1, Corticosteroid-binding globulin, G-protein coupled bile acid receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1955-01-01 (United States) |
Approved indications
- Acquired thrombocytopenia
- Acute lymphoid leukemia
- Adrenal cortical hypofunction
- Adrenogenital disorder
- Allergic bronchopulmonary aspergillosis
- Allergic conjunctivitis
- Allergic rhinitis
- Angioedema
- Ankylosing spondylitis
- Articular gout
- Aspiration pneumonitis
- Asthma
- Atopic dermatitis
- Autoimmune disease
- Autoimmune hemolytic anemia
- Bacterial conjunctivitis
- Bacterial keratitis
- Berylliosis
- Blepharoconjunctivitis
- Bursitis
Common side effects
- Weight gain
- Increased appetite
- Fluid retention
- Nausea
- Hypertension
- Increased sweating
- Facial erythema
- Edema
- Malaise
- Hirsutism
- Menstrual irregularities
- Headache
Serious adverse events
- Peptic ulcer with possible perforation and hemorrhage
- Congestive heart failure
- Aseptic necrosis of femoral and humeral heads
- Osteoporosis
- Pathologic fracture of long bones
- Vertebral compression fractures
- Pancreatitis
- Convulsions
- Posterior subcapsular cataracts
- Increased intracranial pressure with papilledema
Key clinical trials
- Randomized Placebo Controlled Trial of Subcutaneous rhIL-1A (Anakinra) in the Management of Hospitalized Pediatric and Adult Patients With Macrophage Activation Syndrome (Phase 1)
- A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (Phase 1)
- Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial (Phase 4)
- A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic (Phase 3)
- Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) (Phase 4)
- Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 (Phase 3)
- A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery (Phase 3)
- STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) (Phase 3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Prelone CI brief — competitive landscape report
- Prelone updates RSS · CI watch RSS
- Generic (originally Schering) portfolio CI