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Drug ReportsHydrocortisone butyrate
Locoid, Plenadren(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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3M
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2Y
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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
Locoid (generic drugs available since 2004-01-14)
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
LOCOIDBausch Health CompaniesN-022076 RX2007-05-18
1 products, RLD, RS
LOCOIDPrecision DermatologyN-018652 RX1982-10-29
1 products, RLD, RS
LOCOID LIPOCREAMPrecision DermatologyN-020769 RX1997-09-08
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
OTC monograph not final2012-08-24
1 hydrocortisoneOTC monograph not final2016-06-15
1% hydrocortisoneOTC monograph not final2022-12-17
141016 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141017 hydrocortisone 0.5% / hydroquinone 6% / tretinoin 0.025%unapproved drug other2020-07-02
141060 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141061 hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025%unapproved drug other2020-07-02
4149 first aid kitunapproved drug other2024-01-22
4157 first aid kitunapproved drug other2024-01-22
4219 first aid kitunapproved drug other2024-01-22
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
adrenal insufficiency—D000309—
congenital adrenal hyperplasia—D000312E25.0
contact dermatitis—D003877L25
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
hemorrhoidsEFO_0009552D006484K64
inflammationMP_0001845D007249—
leg dermatoses—D007868—
pruritus ani—D011538L29.0
Show 5 more
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
1233 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Adrenal insufficiencyD000309——637132957
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.02328112356
Septic shockD012772—A48.31101681142
Healthy volunteers/patients———92181333
SepsisD018805HP_0100806A41.915851229
Post-traumatic stress disordersD013313EFO_0001358F43.1—3132228
Atopic dermatitisD003876EFO_0000274L201836624
Congenital adrenal hyperplasiaD000312—E25.06863323
ObesityD009765EFO_0001073E66.94——11520
DepressionD003863—F33.932121320
Show 76 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pituitary acth hypersecretionD047748EFO_1001110E24.0—77—1731
LeukemiaD007938—C9521310—225
Prostatic neoplasmsD011471—C614136—425
Cushing syndromeD003480EFO_0003099E24—22—1721
Myeloid leukemia acuteD015470—C92.01172——17
Covid-19D000086382—U07.1——3—1013
Breast neoplasmsD001943EFO_0003869C50—32—913
LymphomaD008223—C85.9176——13
Physiological stressD013312————1—1213
Major depressive disorderD003865EFO_0003761F22121—811
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.914——27
Opioid-related disordersD009293EFO_0005611F1114——37
NeoplasmsD009369—C8025——17
HypertensionD006973EFO_0000537I1012——36
Anorexia nervosaD000856EFO_0004215F50.0—1——56
AgingD000375GO_0007568R41.81—1——56
Anxiety disordersD001008EFO_0006788F41.131——26
Premature birthD047928EFO_0003917O60—1——56
Adrenocortical carcinomaD018268——12——25
StrokeD020521EFO_0000712I63.9—1——45
Show 75 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.12———68
Blood pressureD001794EFO_0004325—2———35
OverweightD050177—E66.31———34
Chronic painD059350HP_0012532—1———34
Cocaine-related disordersD019970—F141———34
Alcohol drinkingD000428EFO_0004329—1———34
Laron syndromeD046150Orphanet_633E34.3211———23
Caregiver burdenD000084802——1———23
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.91———23
FibromyalgiaD005356EFO_0005687M79.11———23
Show 46 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychological distressD000079225——————55
Feeding behaviorD005247——————44
Low back painD017116HP_0003419M54.5————44
Dental anxietyD016854——————44
PregnancyD011247EFO_0002950Z33.1————44
PheochromocytomaD010673——————33
Professional burnoutD002055——————33
MindfulnessD064866——————33
Substance-related disordersD019966EFO_0003890F13————33
Stress fracturesD015775—M84.3————33
Show 204 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 CID26133
DrugBankDB00741
UNII IDWI4X0X7BPJ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,324 adverse events reported
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