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Drug ReportsPrednisolone
Prednisolone
Blephamide, Cetapred, Chloroptic-p, Hydeltra-tba, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prednisolone, Prelone, Sulphrin, 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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Show 7 more
Trade Name
FDA
EMA
Omnipred, Orapred, Pediapred, Pred, Pred mild, Prednisolone, Prelone (discontinued: Cortalone, Delta-cortef, Econopred, Fernisolone-p, Flo-pred, Hydeltrasol, Inflamase, Meti-derm, Meticortelone, Metreton, Orapred, Prednisolone, Prelone, Sterane)
Combinations
Sulfacetamide prednisolone (discontinued: Blephamide, Cetapred, Chloroptic-p, Isopto cetapred, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Poly-pred, Pred, Predamide, Sulfacetamide prednisolone, Sulphrin, Sulster, Vasocidin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prednisolone
Tradename
Company
Number
Date
Products
STERANEPfizerN-009996 DISCN1982-01-01
1 products
DELTA-CORTEFPharmacia & UpjohnN-009987 DISCN1982-01-01
1 products
METI-DERMMerck & CoN-010209 DISCN1982-01-01
1 products
Hide discontinued
Prednisolone sodium phosphate
Tradename
Company
Number
Date
Products
ORAPRED ODTADVANZ PHARMAN-021959 RX2006-06-01
3 products, RLD, RS
PEDIAPREDSeton PharmaceuticalsN-019157 RX1986-05-28
1 products, RLD, RS
Show 2 discontinued
Prednisolone acetate
Tradename
Company
Number
Date
Products
PRED FORTEAbbVieN-017011 RX1982-01-01
1 products, RLD, RS
PRED MILDAbbVieN-017100 RX1982-01-01
1 products, RLD, RS
OMNIPREDSandozN-017469 RX1982-01-01
1 products, RLD, RS
Show 4 discontinued
Prednisolone acetate
+
Sulfacetamide sodium
Tradename
Company
Number
Date
Products
BLEPHAMIDEAllerganN-012813 DISCN1982-01-01
1 products, RLD
METIMYDMerck & CoN-010210 DISCN1982-01-01
2 products
Hide discontinued
Neomycin sulfate
+
Prednisolone sodium phosphate
Tradename
Company
Number
Date
Products
NEO-HYDELTRASOLMerck & CoN-050378 DISCN1982-01-01
1 products
Hide discontinued
Gentamicin sulfate
+
Prednisolone acetate
Tradename
Company
Number
Date
Products
PRED-GAllerganN-050612 DISCN1989-12-01
1 products, RLD
PRED-GAllerganN-050586 DISCN1988-06-10
1 products, RLD
Hide discontinued
Prednisolone sodium phosphate
+
Sulfacetamide sodium
Tradename
Company
Number
Date
Products
VASOCIDINNovartisN-018988 DISCN1988-08-26
1 products, RLD
Hide discontinued
Neomycin sulfate
+
Polymyxin b sulfate
+
Prednisolone acetate
Tradename
Company
Number
Date
Products
POLY-PREDAllerganN-050081 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
blephamideNew Drug Application2013-11-15
cambisonunapproved drug other2018-12-06
desowenANDA, New Drug Application2019-01-28
econopred2006-09-11
ixoba munapproved drug other2021-11-03
orapredNew Drug Application2024-12-05
pediapredNew Drug Application2024-02-01
pred forteNew Drug Application2024-02-29
pred mildNew Drug Application2024-02-29
pred phos - bromunapproved drug other2018-06-08
Show 12 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
leukemia—D007938C95
brain neoplasmsEFO_0003833D001932C71
atopic dermatitisEFO_0000274D003876L20
ulcerative colitisEFO_0000729D003093K51
ankylosing spondylitisEFO_0003898D013167M45
nephrotic syndromeEFO_0004255D009404N04
multiple sclerosisEFO_0003885D009103G35
uveitisHP_0000554D014605H20.9
sarcoidosisEFO_0000690D012507D80-D89
inflammationMP_0001845D007249—
Show 53 more
Agency Specific
FDA
EMA
Expiration
Code
PREDNISOLONE, PREDNISOLONE, AUROBINDO PHARMA LTD
2023-11-18CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Prednisolone Acetate, Flo-Pred, Taro
77993312028-10-11DPU-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
3967 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9451——6
Follicular lymphomaD008224—C82221——3
ArteritisD001167EFO_0009011I77.6——1——1
Takayasu arteritisD013625EFO_1001857M31.4——1——1
Aortic arch syndromesD001015————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.934———4
B-cell lymphomaD016393——44———4
LeukemiaD007938—C9521———2
RecurrenceD012008——11———2
Lymphoid leukemiaD007945—C9121———2
B-cell chronic lymphocytic leukemiaD015451—C91.122———2
Large b-cell lymphoma diffuseD016403—C83.322———2
B-cell lymphoma marginal zoneD018442—C88.411———1
Reactive arthritisD016918EFO_0007460M02.311———1
SyndromeD013577——11———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198——1————1
Acute diseaseD000208——1————1
Philadelphia chromosomeD010677——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePrednisolone
INNprednisolone
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 classsteroids (not prednisolone derivatives); prednisone and prednisolone derivatives
Image (chem structure or protein)Loading
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-ID50-24-8
RxCUI—
ChEMBL IDCHEMBL131
ChEBI ID8378
PubChem CID5755
DrugBankDB00860
UNII ID9PHQ9Y1OLM (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
4306
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
Q96KQ9
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Prednisolone
+
Gentamicin
Total medical expenditures per year (USD, in millions)
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Prednisolone
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Neomycin
+
Polymyxin b
Total medical expenditures per year (USD, in millions)
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Prednisolone
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 95,212 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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151,305 adverse events reported
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