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)

Abbreviated New Drug Application (ANDA)

Gentamicin sulfate

Prednisolone acetate

Tradename	Company	Number	Date	Products
PRED-G	Allergan	N-050586 DISCN	1988-06-10	1 products, RLD
PRED-G	Allergan	N-050612 DISCN	1989-12-01	1 products, RLD

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Neomycin sulfate

Polymyxin b sulfate

Prednisolone acetate

Tradename	Company	Number	Date	Products
POLY-PRED	Allergan	N-050081 DISCN	1982-01-01	1 products

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Neomycin sulfate

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

Tradename	Company	Number	Date	Products
PRED FORTE	AbbVie	N-017011 RX	1982-01-01	1 products, RLD, RS
PRED MILD	AbbVie	N-017100 RX	1982-01-01	1 products, RLD, RS
OMNIPRED	Novartis	N-017469 RX	1982-01-01	1 products, RLD, RS

Show 4 discontinued

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

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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

2387 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	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

Identifiers

PDB	6W9K
CAS-ID	50-24-8
RxCUI	8638
ChEMBL ID	CHEMBL131
ChEBI ID	8378
PubChem CID	5755
DrugBank	DB00860
UNII ID	9PHQ9Y1OLM (ChemIDplus, GSRS)

Target

Agency Approved

NR3C1

Organism

Homo sapiens

Gene name

NR3C1

Gene synonyms

GRL

NCBI Gene ID

2908

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

Q6N0A4

Mouse ortholog

Nr3c1 (14815)

glucocorticoid receptor (Q61629)

Alternate

NR3C2

NR1I2

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

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

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166 adverse events reported

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