ORAPRED ODT (prednisolone sodium phosphate) · ADVANZ PHARMA
Orapred ODT is a synthetic corticosteroid indicated for use as an anti-inflammatory or immunosuppressive agent in both adult and pediatric populations. It is prescribed for a wide array of conditions, including severe allergic reactions, dermatologic diseases, gastrointestinal flares (such as Crohn's disease and ulcerative colitis), and hematologic disorders. Additionally, the medication is used for the management of specific endocrine, renal, respiratory, and rheumatologic conditions, the treatment of ophthalmic and nervous system disorders (including acute exacerbations of multiple sclerosis), and the palliation of certain neoplastic conditions like leukemia and lymphoma.
How ORAPRED ODT Works
Prednisolone is a synthetic adrenocortical steroid with potent glucocorticoid properties and slight mineralocorticoid activity. It exerts anti-inflammatory effects by inhibiting leukocyte migration, reducing capillary permeability, and suppressing the inflammatory response (including edema and fibrin deposition). As an immunosuppressant, it reduces the production of lymphocytes and eosinophils. Furthermore, it influences metabolic processes by promoting gluconeogenesis, increasing protein catabolism, and stimulating lipolysis. It also suppresses the production of endogenous corticosteroids by inhibiting the secretion of corticotropin.
Details
- Status
- Prescription
- First Approved
- 2006-06-01
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
ORAPRED ODT Approval History
What ORAPRED ODT Treats
20 indicationsORAPRED ODT is approved for 20 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
- Drug Hypersensitivity
- Allergic Rhinitis
- Serum Sickness
- Dermatitis Herpetiformis
- Contact Dermatitis
- Exfoliative Erythroderma
- Mycosis Fungoides
- Pemphigus
- Erythema Multiforme
- Congenital Adrenal Hyperplasia
- Hypercalcemia of Malignancy
- Thyroiditis
- Adrenocortical Insufficiency
- Crohn's Disease
- Ulcerative Colitis
- Hemolytic Anemia
- Diamond-Blackfan Anemia
- Idiopathic Thrombocytopenic Purpura
- Pure Red Cell Aplasia
ORAPRED ODT 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 ORAPRED ODT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ORAPRED ODT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ORAPRED ODT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03484507 | UCSF-IRB-17-23895 | Ph 2 | completed | Parasitic Ulcer Treatment Trial Pilot |
| NCT05444699 RhinoPOCRCT | OY102021 2024-512561-13-00, 2021-006050-31 | Ph 4 | recruiting | Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age |
| NCT03698630 | RESP_301_2010 2010-022001-18, ISRCTN26944158 | Ph 4 | completed | Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children |
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.
ORAPRED ODT FDA Label Details
Indications & Usage
FDA Label (PDF)Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation for the treatment of certain endocrine conditions for palliation of certain neoplastic conditions 1.1 Allergic Conditions Control of severe or incapacitating al...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.