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Drug ReportsHydrocortisone butyrate
Hydrocortisone butyrate
Alkindi, Efmody, Hydrocortisone Butyrate, Locoid, Plenadren (hydrocortisone butyrate) is a small molecule pharmaceutical. Hydrocortisone butyrate was first approved as Locoid on 1982-03-31. 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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Target
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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
Hydrocortisone butyrate, Locoid (discontinued: Hydrocortisone butyrate, Locoid)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrocortisone butyrate
Tradename
Company
Number
Date
Products
LOCOIDBausch Health CompaniesN-018514 RX1982-03-31
1 products, RLD, RS
LOCOIDBausch Health CompaniesN-019116 RX1987-02-25
1 products, RLD, RS
LOCOID LIPOCREAMPrecision DermatologyN-020769 RX1997-09-08
1 products, RLD, RS
LOCOIDPrecision DermatologyN-018652 RX1982-10-29
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aquax-hunapproved drug other2024-12-31
evesseANDA2026-02-28
hydrocortisone butyrateANDA2026-07-14
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
Patent
Expires
Flag
FDA Information
Hydrocortisone Butyrate, Locoid, Bausch
79818772025-01-23DP
ATC Codes
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB02: Hydrocortisone butyrate
— D07B: Corticosteroids, combinations with antiseptics
— D07BB: Corticosteroids, moderately potent, combinations with antiseptics
— D07BB04: Hydrocortisone butyrate and antiseptics
HCPCS
No data
Clinical
Clinical Trials
1568 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
LeukemiaD007938—C952030142460
DepressionD003863—F33.975224860
Septic shockD012772—A48.311218111855
Healthy volunteers/patients———124182448
Cushing syndromeD003480EFO_0003099E24211513048
SepsisD018805EFO_0001420A41.9181491746
Psychological stressD013315——2—114044
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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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Motor activityD009043EFO_0003940——1——2324
RecurrenceD012008——1010——316
Stress fracturesD015775—M84.311——1416
Adrenal gland neoplasmsD000310EFO_0003850C74—1——1112
Opioid-related disordersD009293EFO_0005611F1114——59
Hematologic neoplasmsD019337——44——18
Adrenocortical carcinomaD018268——14——38
StrokeD020521EFO_0000712I63.9—1——78
Parkinson diseaseD010300EFO_0002508G2012——58
Anorexia nervosaD000856EFO_0004215F50.0—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———78
Caregiver burdenD000084802——1———56
Blood pressureD001794EFO_0004325—2———35
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
Show 66 more
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
Show 377 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydrocortisone butyrate
INNhydrocortisone
Description
Cortisol 17-butyrate is cortisol esterified with butyric acid at the 17-hydroxy group. It has a role as a dermatologic drug and a drug allergen. It is a cortisol ester, a butyrate ester and a primary alpha-hydroxy ketone.
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)CO)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-ID13609-67-1
RxCUI—
ChEMBL IDCHEMBL1683
ChEBI ID31674
PubChem CID—
DrugBankDB00741
UNII IDWI4X0X7BPJ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 410 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,063 adverse events reported
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