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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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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: Cortef, 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
Hydrocortisone cypionate
Tradename
Company
Number
Date
Products
CORTEFPharmacia & UpjohnN-009900 DISCN1982-01-01
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
OTC monograph not final2012-08-24
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
999 itch relievingOTC monograph not final2016-11-14
advanced anti-itch therapyOTC monograph not final2016-06-14
afassco 1% hydrocortisoneOTC monograph not final2023-01-12
aftate hydrocortisone creamOTC monograph not final2016-03-31
ala-scalpANDA2025-01-08
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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
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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
1323 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Memory disordersD008569———1———1
Indications Phases 1
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Indications Without Phase
No data
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
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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 74,445 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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27,653 adverse events reported
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