Locoid, Plenadren(hydrocortisone butyrate)
Alkindi, Efmody, 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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
| immune system diseases | D007154 |
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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 |
|---|---|---|---|---|
| LOCOID | Bausch Health Companies | N-018514 RX | 1982-03-31 | 1 products, RLD, RS |
| LOCOID | Bausch Health Companies | N-019116 RX | 1987-02-25 | 1 products, RLD, RS |
| LOCOID | Bausch Health Companies | N-022076 RX | 2007-05-18 | 1 products, RLD, RS |
| LOCOID | Precision Dermatology | N-018652 RX | 1982-10-29 | 1 products, RLD, RS |
| LOCOID LIPOCREAM | Precision Dermatology | N-020769 RX | 1997-09-08 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alkindi | New Drug Application | 2021-03-15 |
| aquax-h | unapproved drug other | 2021-12-20 |
| hydrocortisone | OTC monograph not final | 2023-06-13 |
| locoid | New Drug Application | 2021-03-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenal insufficiency | — | D000309 | — |
| congenital adrenal hyperplasia | — | D000312 | E25.0 |
| contact dermatitis | — | D003877 | L25 |
| facial dermatoses | — | D005148 | — |
| foot dermatoses | — | D005533 | — |
| hand dermatoses | — | D006229 | — |
| hemorrhoids | EFO_0009552 | D006484 | K64 |
| inflammation | MP_0001845 | D007249 | — |
| leg dermatoses | — | D007868 | — |
| pruritus ani | — | D011538 | L29.0 |
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Agency Specific
FDA
EMA
No data
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
206 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Surgical wound infection | D013530 | — | 4 | 4 | 7 | 9 | 23 | ||
| Covid-19 | D000086382 | U07.1 | 4 | 6 | 1 | 4 | 3 | 16 | |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 3 | 3 | 8 | |
| Wound infection | D014946 | — | — | 4 | 1 | 1 | 6 | ||
| Postoperative pain | D010149 | G89.18 | — | — | — | 1 | 3 | 4 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | 1 | 2 | 4 |
| Malignant pleural effusion | D016066 | J91.0 | 1 | — | 1 | 1 | 1 | 4 | |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | — | 3 | 1 | 4 |
| Sars-cov-2 | D000086402 | 1 | 1 | — | 1 | — | 3 | ||
| Eye infections | D015817 | EFO_1001888 | — | — | 1 | 2 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | T14.8 | — | — | 1 | — | 1 | 2 | |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | — | 1 | — | — | 1 |
| Otitis externa | D010032 | EFO_0009560 | H60 | — | — | 1 | — | — | 1 |
| Lacerations | D022125 | — | — | 1 | — | — | 1 | ||
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | 1 | — | — | 1 | ||
| Rna virus infections | D012327 | — | — | 1 | — | — | 1 | ||
| Self efficacy | D020377 | — | — | 1 | — | — | 1 | ||
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dental pins | D003772 | — | 1 | — | — | — | 1 | ||
| Acanthamoeba keratitis | D015823 | EFO_0007126 | — | 1 | — | — | — | 1 | |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | 1 | 1 | — | — | — | 1 | |
| Warts | D014860 | B07 | — | 1 | — | — | — | 1 | |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 1 | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | — | 1 |
| Corneal ulcer | D003320 | H16.0 | — | 1 | — | — | — | 1 | |
| Blindness | D001766 | HP_0000618 | H53.12 | — | 1 | — | — | — | 1 |
| Malignant mesothelioma | D000086002 | 1 | 1 | — | — | — | 1 | ||
| Pleural empyema | D016724 | J86 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ingrown nails | D009263 | L60.0 | 1 | — | — | — | — | 1 | |
| Rhinoplasty | D012225 | 1 | — | — | — | — | 1 | ||
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | — | — | — | — | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | — | — | — | 1 |
| Diabetic angiopathies | D003925 | EFO_1000896 | 1 | — | — | — | — | 1 | |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | 2 | 2 | |
| Head and neck neoplasms | D006258 | — | — | — | — | 2 | 2 | ||
| Cesarean section | D002585 | — | — | — | — | 2 | 2 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | — | 2 | 2 |
| Intraoperative complications | D007431 | — | — | — | — | 2 | 2 | ||
| Hypothermia | D007035 | HP_0002045 | T68 | — | — | — | — | 2 | 2 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | — | — | 1 | 1 |
| Aortic valve disease | D000082862 | — | — | — | — | 1 | 1 | ||
| Coronary artery disease | D003324 | I25.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | HYDROCORTISONE BUTYRATE |
| INN | hydrocortisone |
| 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 class | cortisone derivatives |
| Image (chem structure or protein) | |
| 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-ID | 13609-67-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1683 |
| ChEBI ID | 31674 |
| PubChem CID | 26133 |
| DrugBank | DB00741 |
| UNII ID | WI4X0X7BPJ (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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68 adverse events reported
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