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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| musculoskeletal diseases | D009140 |
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| nervous system diseases | D009422 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
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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
+
Prednisolone acetate
Neomycin sulfate
+
Polymyxin b sulfate
+
Prednisolone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| POLY-PRED | Allergan | N-050081 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Neomycin sulfate
+
Prednisolone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEO-HYDELTRASOL | Merck KGaA | N-050378 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Prednisolone
Prednisolone acetate
Prednisolone acetate
+
Sulfacetamide sodium
Prednisolone sodium phosphate
Prednisolone sodium phosphate
+
Sulfacetamide sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VASOCIDIN | Novartis | N-018988 DISCN | 1988-08-26 | 1 products, RLD |
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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 |
|---|---|---|
| blephamide | New Drug Application | 2013-11-15 |
| econopred | 2006-09-11 | |
| orapred | New Drug Application | 2022-02-16 |
| pediapred | New Drug Application | 2020-01-29 |
| prednisolone sodium phosphate | ANDA | 2023-05-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenal insufficiency | — | D000309 | — |
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| asthma | EFO_0000270 | D001249 | J45 |
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
| berylliosis | EFO_0007168 | D001607 | J63.2 |
| brain neoplasms | EFO_0003833 | D001932 | C71 |
| collagen diseases | — | D003095 | — |
| conjunctivitis | — | D003231 | H10 |
| dermatitis herpetiformis | — | D003874 | L13.0 |
| edema | — | D004487 | R60.9 |
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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
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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 | 48 | 150 | 55 | 6 | 8 | 238 | |
| Lymphoma | D008223 | C85.9 | 29 | 110 | 51 | 1 | 15 | 191 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 18 | 44 | 24 | 16 | 7 | 100 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 31 | 55 | 20 | 1 | 2 | 90 | |
| Multiple myeloma | D009101 | C90.0 | 13 | 30 | 20 | 2 | 2 | 57 | |
| Castration-resistant prostatic neoplasms | D064129 | 16 | 29 | 11 | 3 | 2 | 51 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 4 | 16 | 12 | 15 | 5 | 50 |
| Asthma | D001249 | EFO_0000270 | J45 | 6 | 5 | 11 | 12 | 10 | 44 |
| Graft vs host disease | D006086 | D89.81 | 5 | 21 | 11 | 1 | 6 | 41 | |
| Covid-19 | D000086382 | U07.1 | — | 9 | 17 | 3 | 7 | 32 |
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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 | 14 | 61 | 26 | — | 9 | 100 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 15 | 33 | 8 | — | 2 | 49 | |
| Myelodysplastic syndromes | D009190 | D46 | 10 | 36 | 2 | — | 4 | 47 | |
| Hodgkin disease | D006689 | C81 | 4 | 18 | 11 | — | 1 | 30 | |
| Plasma cell neoplasms | D054219 | 6 | 14 | 6 | — | 4 | 29 | ||
| Neoplasms | D009369 | C80 | 13 | 10 | 5 | — | 2 | 28 | |
| T-cell lymphoma peripheral | D016411 | C84.9 | 6 | 14 | 4 | — | — | 23 | |
| B-cell lymphoma | D016393 | 11 | 12 | 3 | — | — | 22 | ||
| Adenocarcinoma | D000230 | 1 | 16 | 1 | — | — | 18 | ||
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 2 | 10 | 2 | — | — | 12 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | D47.1 | 4 | 9 | — | — | 2 | 15 | |
| Myelodysplastic-myeloproliferative diseases | D054437 | 1 | 8 | — | — | 2 | 11 | ||
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 3 | 6 | — | — | 1 | 8 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 2 | 5 | — | — | — | 6 | |
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | 2 | 3 | — | — | — | 4 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | 1 | 3 | — | — | — | 4 | |
| Plasmablastic lymphoma | D000069293 | C83.3 | 4 | 2 | — | — | — | 4 | |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 4 | 1 | — | — | — | 4 | ||
| Non-small-cell lung carcinoma | D002289 | 2 | 3 | — | — | — | 4 | ||
| Myeloid leukemia chronic-phase | D015466 | — | 4 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | — | — | 2 | 3 | |
| Therapeutic equivalency | D013810 | 3 | — | — | — | — | 3 | ||
| T-cell leukemia | D015458 | 2 | — | — | — | — | 2 | ||
| Syndrome | D013577 | 1 | — | — | — | 1 | 2 | ||
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | 1 | — | — | — | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | 1 | 2 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 2 | — | — | — | — | 2 |
| Drug hypersensitivity syndrome | D063926 | EFO_1002004 | D72.12 | 1 | — | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | 1 | — | — | — | — | 1 | ||
| Urologic neoplasms | D014571 | C64-C68 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | 3 | 3 | ||
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | 2 | 2 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 2 | 2 | |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 2 | 2 | |
| Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
| Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
| Undifferentiated connective tissue diseases | D000074079 | — | — | — | — | 1 | 1 | ||
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | — | — | — | 1 | 1 |
| Hypertrophic cicatrix | D017439 | L91.0 | — | — | — | — | 1 | 1 |
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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 |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
NR3C2
NR3C2
NR1I2
NR1I2
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
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
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Adverse Events
Top Adverse Reactions
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166 adverse events reported
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