Prednisolone
Blephamide, Cetapred, Chloroptic-p, Cortalone, Delta-cortef, Fernisolone-p, Hydeltra-tba, Meti-derm, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prelone, Sterane, Sulphrin, Sulster, Vasocidin (prednisolone) is a small molecule pharmaceutical. Prednisolone was first approved as Chloroptic-p s.o.p. on 1982-01-01. It is used to treat adrenal insufficiency, ankylosing spondylitis, asthma, atopic dermatitis, and berylliosis amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor and nuclear receptor subfamily 1 group I member 2.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Omnipred, Orapred, Pediapred, Pred, Pred mild (generic drugs available since 1982-01-01, discontinued: Cortalone, Delta-cortef, Econopred, Fernisolone-p, Flo-pred, Hydeltra-tba, Hydeltrasol, Inflamase, Inflamase mild, Meti-derm, Meticortelone, Metreton, Predair, Prelone, Sterane)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gentamicin sulfate
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Prednisolone acetate
Neomycin sulfate
+
Polymyxin b sulfate
+
Prednisolone acetate
Neomycin sulfate
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Prednisolone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEO-HYDELTRASOL | Merck KGaA | N-050378 DISCN | 1982-01-01 | 1 products |
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Prednisolone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| STERANE | Mylan | N-009996 DISCN | 1982-01-01 | 1 products |
| DELTA-CORTEF | Pharmacia & Upjohn | N-009987 DISCN | 1982-01-01 | 1 products |
| METI-DERM | Merck Sharp & Dohme | N-010209 DISCN | 1982-01-01 | 1 products |
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Prednisolone acetate
Prednisolone acetate
+
Sulfacetamide sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BLEPHAMIDE | Allergan | N-012813 DISCN | 1982-01-01 | 1 products, RLD |
| METIMYD | Merck Sharp & Dohme | N-010210 DISCN | 1982-01-01 | 2 products |
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Prednisolone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORAPRED ODT | Concordia Laboratories | N-021959 RX | 2006-06-01 | 3 products, RLD, RS |
| PEDIAPRED | Seton Pharmaceuticals | N-019157 RX | 1986-05-28 | 1 products, RLD, RS |
Show 2 discontinued
Prednisolone sodium phosphate
+
Sulfacetamide sodium
Prednisolone tebutate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDELTRA-TBA | Merck KGaA | N-010562 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| desowen | ANDA, New Drug Application | 2015-04-23 |
| pred phos - brom | unapproved drug other | 2018-06-08 |
| pred-brom | unapproved drug other | 2018-03-01 |
| pred-gati | unapproved drug other | 2018-02-22 |
| pred-gati-brom | unapproved drug other | 2018-02-22 |
| verdeso | New Drug Application | 2021-08-01 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PREDNISOLONE, PREDNISOLONE, AUROBINDO PHARMA LTD | |||
| 2023-11-18 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Prednisolone Acetate, Flo-Pred, Taro | |||
| 7799331 | 2028-10-11 | DP | U-139, U-1068 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC54: Prednisolone, combinations
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA01: Prednisolone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA04: Prednisolone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA03: Prednisolone
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA01: Prednisolone and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA03: Prednisolone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA02: Prednisolone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB06: Prednisolone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD02: Prednisolone
— R01AD52: Prednisolone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA04: Prednisolone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB02: Prednisolone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA02: Prednisolone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB02: Prednisolone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA03: Prednisolone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA01: Prednisolone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA02: Prednisolone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA02: Prednisolone and antiinfectives
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
HCPCS
Code | Description |
|---|---|
| J1020 | Injection, methylprednisolone acetate, 20 mg |
| J1030 | Injection, methylprednisolone acetate, 40 mg |
| J1040 | Injection, methylprednisolone acetate, 80 mg |
| J2650 | Injection, prednisolone acetate, up to 1 ml |
| J2920 | Injection, methylprednisolone sodium succinate, up to 40 mg |
| J2930 | Injection, methylprednisolone sodium succinate, up to 125 mg |
| J7509 | Methylprednisolone oral, per 4 mg |
| J7510 | Prednisolone oral, per 5 mg |
Clinical
Clinical Trials
3790 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 62 | 186 | 63 | 8 | 14 | 297 |
| Lymphoma | D008223 | — | C85.9 | 33 | 119 | 56 | 1 | 20 | 213 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 39 | 93 | 42 | 4 | 4 | 158 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 25 | 62 | 33 | 17 | 13 | 132 |
| Multiple myeloma | D009101 | — | C90.0 | 17 | 44 | 32 | 3 | 4 | 87 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 4 | 23 | 21 | 28 | 10 | 84 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 22 | 46 | 18 | 3 | 2 | 78 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 21 | 48 | 12 | 2 | 7 | 78 |
| Kidney transplantation | D016030 | — | — | 6 | 18 | 14 | 29 | 4 | 67 |
| Asthma | D001249 | EFO_0000270 | J45 | 6 | 9 | 14 | 20 | 18 | 65 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 17 | 70 | 29 | — | 13 | 113 |
| Myelodysplastic syndromes | D009190 | — | D46 | 13 | 44 | 2 | — | 4 | 56 |
| Hodgkin disease | D006689 | — | C81 | 8 | 33 | 15 | — | 2 | 50 |
| Plasma cell neoplasms | D054219 | — | — | 6 | 14 | 6 | — | 4 | 29 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 15 | 3 | — | — | 19 |
| Adenocarcinoma | D000230 | — | — | 1 | 16 | 1 | — | — | 18 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 7 | 12 | 3 | — | — | 16 |
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | 1 | 3 | 8 | — | 4 | 15 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 7 | 4 | — | 2 | 12 |
| T-cell lymphoma | D016399 | — | — | 4 | 3 | 3 | — | 2 | 12 |
Show 145 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | — | D47.1 | 5 | 11 | — | — | 2 | 17 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | 8 | — | — | 2 | 11 |
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 5 | — | — | — | 8 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 3 | 6 | — | — | 1 | 8 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 6 | — | — | — | 7 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | 1 | 6 | — | — | — | 7 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 2 | 5 | — | — | — | 6 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 3 | — | — | 3 | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 6 | — | — | — | 6 |
| Melanoma | D008545 | — | — | 1 | 4 | — | — | — | 5 |
Show 182 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | 4 | 5 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Tinnitus | D014012 | HP_0000360 | H93.1 | 1 | — | — | — | 2 | 3 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | 1 | 2 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 2 | — | — | — | — | 2 |
| Fever | D005334 | HP_0001945 | R50.9 | 1 | — | — | — | 1 | 2 |
| Drug hypersensitivity syndrome | D063926 | EFO_1002004 | D72.12 | 1 | — | — | — | 1 | 2 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
Show 27 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 3 | 3 |
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | — | 3 | 3 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 3 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 3 | 3 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Granulomatous mastitis | D058890 | — | N61.2 | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 2 | 2 |
| Aortic valve stenosis | D001024 | HP_0001650 | — | — | — | — | — | 2 | 2 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | — | — | — | 2 | 2 |
Show 137 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prednisolone |
| INN | prednisolone |
| Description | Prednisolone is a glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. It has a role as an adrenergic agent, an anti-inflammatory drug, an antineoplastic agent, an immunosuppressive agent, a drug metabolite, an environmental contaminant and a xenobiotic. It is a glucocorticoid, an 11beta-hydroxy steroid, a 21-hydroxy steroid, a 17alpha-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone and a C21-steroid. It is functionally related to a Delta(1)-progesterone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives); prednisone and prednisolone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12C[C@H](O)[C@H]3[C@@H](CCC4=CC(=O)C=C[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 50-24-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL131 |
| ChEBI ID | 8378 |
| PubChem CID | 5755 |
| DrugBank | DB00860 |
| UNII ID | 9PHQ9Y1OLM (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
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Financial
Revenue by drug
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Prednisolone
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Gentamicin
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Prednisolone
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Neomycin
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Polymyxin b
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Prednisolone
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Safety
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108,450 adverse events reported
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