Pandel, Plenadren(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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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
Pandel
Drug Products
FDA
EMA
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 |
|---|---|---|---|---|
| PANDEL | ANI PHARMS | N-020453 RX | 1997-02-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alkindi | New Drug Application | 2021-03-15 |
| hydrocortisone | OTC monograph not final | 2023-06-13 |
| pandel | New Drug Application | 2022-09-30 |
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
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
104 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 3 | — | 2 | — | 8 |
| Dehydration | D003681 | E86.0 | 1 | — | 1 | 4 | — | 6 | |
| Healthy volunteers/patients | — | 2 | — | — | 1 | — | 3 | ||
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | 2 | — | 3 |
| Pigmentation | D010858 | CHEBI_26130 | — | — | — | 1 | — | 1 | |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | 1 | — | 1 |
| Skin aging | D015595 | EFO_0005422 | — | — | — | 1 | — | 1 | |
| Edema | D004487 | R60.9 | — | — | — | 1 | — | 1 | |
| Surgical wound infection | D013530 | — | — | — | 1 | — | 1 | ||
| Trismus | D014313 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 4 | 2 | 2 | — | 1 | 8 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 1 | 2 | — | — | 4 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 3 | 1 | — | — | 4 |
| Primary immunodeficiency diseases | D000081207 | 1 | 2 | 2 | — | — | 3 | ||
| Postoperative pain | D010149 | G89.18 | — | 1 | 1 | — | 2 | 3 | |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | 2 | — | — | 3 | |
| Pancreatic ductal carcinoma | D021441 | 1 | — | 1 | — | — | 2 | ||
| Vitreous hemorrhage | D014823 | EFO_0008626 | H43.1 | — | — | 2 | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | 1 | — | — | 1 | ||
| Bursitis | D002062 | EFO_1000941 | M71.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | C80 | 2 | 2 | — | — | — | 3 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 2 | — | — | — | 3 | |
| Follicular lymphoma | D008224 | C82 | 2 | 2 | — | — | — | 3 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 2 | 2 | — | — | — | 3 | |
| Mantle-cell lymphoma | D020522 | C83.1 | — | 2 | — | — | — | 2 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 2 | — | — | — | 2 | |
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | 2 | — | — | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
| Familial dysautonomia | D004402 | Orphanet_1764 | G90.1 | 1 | — | — | — | — | 1 |
| Burkitt lymphoma | D002051 | C83.7 | 1 | — | — | — | — | 1 | |
| Localized scleroderma | D012594 | L94.0 | 1 | — | — | — | — | 1 | |
| Crest syndrome | D017675 | M34.1 | 1 | — | — | — | — | 1 | |
| Microstomia | D008865 | HP_0000160 | Q18.5 | 1 | — | — | — | — | 1 |
| Scleromyxedema | D053718 | L98.5 | 1 | — | — | — | — | 1 | |
| Hemolytic anemia | D000743 | D55-D59 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 2 | 2 |
| Intraocular pressure | D007429 | — | — | — | — | 1 | 1 | ||
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | HYDROCORTISONE PROBUTATE |
| INN | hydrocortisone |
| 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 class | cortisone derivatives |
| Image (chem structure or protein) | |
| 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-ID | 72590-77-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200953 |
| ChEBI ID | 31675 |
| PubChem CID | 5754 |
| DrugBank | DB00741 |
| UNII ID | WI4X0X7BPJ (ChemIDplus, GSRS) |
Target
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Alternate
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Variants
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Trends
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Safety
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Adverse Events
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5,375 adverse events reported
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