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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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FDA
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Drug Products
FDA
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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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FDA
EMA
Brand Name
Status
Last Update
analpram hcANDA2025-06-09
aquax-hunapproved drug other2024-12-31
hydrocortisone butyrateNDA authorized generic2025-06-05
Agency Specific
FDA
EMA
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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
1567 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—C91.02844183481
Adrenal insufficiencyD000309——6611223679
Anxiety disordersD001008EFO_0006788F41.176—35367
DepressionD003863—F33.975224860
LeukemiaD007938—C951930132458
Septic shockD012772—A48.311218111855
Healthy volunteers/patients———124182448
Cushing syndromeD003480EFO_0003099E24211513048
SepsisD018805EFO_0001420A41.9181491746
Psychological stressD013315——2—114145
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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—629
Myeloid leukemia acuteD015470—C92.016113——27
Physiological stressD013312————1—2223
Breast neoplasmsD001943EFO_0003869C50—43—1520
Covid-19D000086382—U07.1——7—1219
Non-hodgkin lymphomaD008228—C85.96112—219
Burkitt lymphomaD002051—C83.71115——16
NeoplasmsD009369—C80381—616
Psychological well-beingD000092862——1—1—1416
AlcoholismD000437EFO_0003829F10.1511—915
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Indications Phases 2
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———78
Caregiver burdenD000084802——1———56
Blood pressureD001794EFO_0004325—2———35
Chronic painD059350——1———45
Cocaine-related disordersD019970—F141———45
FibromyalgiaD005356EFO_0005687M79.11———45
Sleep deprivationD012892—F51.122———24
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 implantsD015921——————1111
Dental anxietyD016854——————1010
Psychological burnoutD000077062—Z73.0————99
Breast feedingD001942——————88
Psychological distressD000079225——————88
Nursing careD009732——————77
Occupational stressD000073397——————77
PregnancyD011247EFO_0002950Z33.1————77
ExerciseD015444EFO_0000483—————66
InfertilityD007246EFO_0000545—————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
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Variants
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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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913 adverse events reported
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