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Drug ReportsHydrocortisone probutate
Hydrocortisone probutate
Alkindi, Efmody, Pandel, Plenadren (hydrocortisone probutate) is a small molecule pharmaceutical. Hydrocortisone probutate was first approved as Pandel on 1997-02-28. It is used to treat adrenal insufficiency, congenital adrenal hyperplasia, contact dermatitis, facial dermatoses, and foot dermatoses amongst others in the USA. It has been approved in Europe to treat adrenal insufficiency and congenital adrenal hyperplasia.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
immune system diseasesD007154
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrocortisone probutate
Tradename
Company
Number
Date
Products
PANDELANI PharmaceuticalsN-020453 DISCN1997-02-28
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
analpram hcANDA2025-06-09
aquax-hunapproved drug other2024-12-31
hydrocortisone butyrateNDA authorized generic2025-06-05
locoidNew Drug Application2023-10-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
shock—D012769R57.1
ulcerative colitisEFO_0000729D003093K51
pruritus ani—D011538L29.0
inflammationMP_0001845D007249—
adrenal insufficiency—D000309—
rheumatic diseases—D012216M79.0
status asthmaticus—D013224—
contact dermatitis—D003877L25
facial dermatoses—D005148—
hemorrhoidsEFO_0009552D006484K64
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC03: Hydrocortisone
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA02: Hydrocortisone
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
— C05AA01: Hydrocortisone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA02: Hydrocortisone
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB02: Hydrocortisone butyrate
— D07AB11: Hydrocortisone buteprate
— D07AC: Corticosteroids, potent (group iii)
— D07AC16: Hydrocortisone aceponate
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA04: Hydrocortisone and antiseptics
— D07BB: Corticosteroids, moderately potent, combinations with antiseptics
— D07BB04: Hydrocortisone butyrate and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA01: Hydrocortisone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA01: Hydrocortisone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB09: Hydrocortisone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD60: Hydrocortisone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA02: Hydrocortisone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB01: Hydrocortisone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA03: Hydrocortisone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB03: Hydrocortisone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA01: Hydrocortisone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA03: Hydrocortisone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA04: Hydrocortisone and antiinfectives
HCPCS
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Clinical
Clinical Trials
1417 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.02642193479
Adrenal insufficiencyD000309——6611203576
LeukemiaD007938—C952435152467
Anxiety disordersD001008EFO_0006788F41.176—34256
Septic shockD012772—A48.31111891751
DepressionD003863—F33.975223951
Cushing syndromeD003480EFO_0003099E24210512845
Healthy volunteers/patients———124182044
SepsisD018805EFO_0001420A41.9161491744
Pituitary acth hypersecretionD047748EFO_1001110E24.0—8712541
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C615137—528
Myeloid leukemia acuteD015470—C92.015103——25
Premature birthD047928EFO_0003917O60112—1923
Ectopic acth syndromeD000182EFO_1001256E24.3164—1122
Physiological stressD013312————1—1920
Covid-19D000086382—U07.1——7—1219
Non-hodgkin lymphomaD008228—C85.97112—219
Breast neoplasmsD001943EFO_0003869C50—43—1419
HyperaldosteronismD006929—E26——1—1718
NeoplasmsD009369—C80471—616
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Motor activityD009043EFO_0003940——1——1819
RecurrenceD012008——98——314
Stress fracturesD015775—M84.311——1214
Adrenal gland neoplasmsD000310EFO_0003850C74—1——1011
Opioid-related disordersD009293EFO_0005611F1114——59
Hematologic neoplasmsD019337——44——18
Parkinson diseaseD010300EFO_0002508G2012——58
Adrenocortical carcinomaD018268——13——37
Anorexia nervosaD000856EFO_0004215F50.0—1——67
StrokeD020521EFO_0000712I63.9—1——67
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F131———89
OverweightD050177—E66.31———67
Blood pressureD001794EFO_0004325—2———35
Caregiver burdenD000084802——1———45
Chronic painD059350——1———45
Cocaine-related disordersD019970—F141———45
Sleep deprivationD012892—F51.122———24
FibromyalgiaD005356EFO_0005687M79.11———34
AgnosiaD000377EFO_0007136F881———34
Alcohol drinkingD000428EFO_0004329—1———34
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dental anxietyD016854——————99
Psychological distressD000079225——————88
Dental implantsD015921——————88
Psychological burnoutD000077062—Z73.0————77
Nursing careD009732——————66
PregnancyD011247EFO_0002950Z33.1————66
InfertilityD007246EFO_0000545—————55
Breast feedingD001942——————55
Low back painD017116—M54.5————55
Occupational stressD000073397——————55
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydrocortisone probutate
INNhydrocortisone
Description
Cortisol is a 17alpha-hydroxy-C21-steroid that is pregn-4-ene substituted by oxo groups at positions 3 and 20 and hydroxy groups at positions 11, 17 and 21. Cortisol is a corticosteroid hormone or glucocorticoid produced by zona fasciculata of the adrenal cortex, which is a part of the adrenal gland. It is usually referred to as the "stress hormone" as it is involved in response to stress and anxiety, controlled by corticotropin-releasing hormone (CRH). It increases blood pressure and blood sugar, and reduces immune responses. It has a role as an anti-inflammatory drug, an anti-allergic agent, an anti-asthmatic drug, a human metabolite, a mouse metabolite and a drug allergen. It is a 21-hydroxy steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(4) steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone, a 17alpha-hydroxy-C21-steroid and a glucocorticoid. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug classcortisone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCC(=O)O[C@]1(C(=O)COC(=O)CC)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Identifiers
PDB—
CAS-ID72590-77-3
RxCUI—
ChEMBL IDCHEMBL1200953
ChEBI ID31675
PubChem CID5754
DrugBankDB00741
UNII IDWI4X0X7BPJ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 67 documents
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Safety
Black-box Warning
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Adverse Events
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475 adverse events reported
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