Prednisolone tebutate
Blephamide, Cetapred, Chloroptic-p, Hydeltra-tba, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prednisolone, Prelone, Sulphrin, Vasocidin (prednisolone tebutate) is a small molecule pharmaceutical. Prednisolone tebutate was first approved as Chloroptic-p s.o.p. on 1982-01-01. It is used to treat adrenal insufficiency, ankylosing spondylitis, asthma, atopic dermatitis, and berylliosis amongst others in the USA.
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Drug Products
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Abbreviated New Drug Application (ANDA)
Prednisolone tebutate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDELTRA-TBA | Merck & Co | N-010562 DISCN | 1982-01-01 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| blephamide | New Drug Application | 2013-11-15 |
| cambison | unapproved drug other | 2018-12-06 |
| econopred | 2006-09-11 | |
| ixoba m | unapproved drug other | 2021-11-03 |
| orapred | New Drug Application | 2024-06-10 |
| pediapred | New Drug Application | 2024-02-01 |
| pred forte | New Drug Application | 2024-02-29 |
| pred mild | New Drug Application | 2024-02-29 |
| pred phos - brom | unapproved drug other | 2018-06-08 |
| pred-brom | unapproved drug other | 2018-03-01 |
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Prednisolone Acetate, Flo-Pred, Taro | |||
| 7799331 | 2028-10-11 | DP | U-139, U-1068 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC04: Prednisolone
— A01AC54: Prednisolone, combinations
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA01: Prednisolone
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
— C05AA04: Prednisolone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA03: Prednisolone
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA01: Prednisolone and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA03: Prednisolone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA02: Prednisolone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB06: Prednisolone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD02: Prednisolone
— R01AD52: Prednisolone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA04: Prednisolone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB02: Prednisolone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA02: Prednisolone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB02: Prednisolone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA03: Prednisolone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA01: Prednisolone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA02: Prednisolone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA02: Prednisolone and antiinfectives
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
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Clinical
Clinical Trials
2158 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 37 | 109 | 57 | 6 | 16 | 202 |
| Leukemia | D007938 | — | C95 | 22 | 80 | 29 | 7 | 11 | 132 |
| Syndrome | D013577 | — | — | 17 | 54 | 25 | 17 | 23 | 123 |
| Prostatic neoplasms | D011471 | — | C61 | 21 | 56 | 28 | 6 | 9 | 107 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 8 | 40 | 27 | 9 | 5 | 80 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 3 | 20 | 22 | 19 | 8 | 70 |
| Lymphoid leukemia | D007945 | — | C91 | 8 | 37 | 20 | 7 | 4 | 70 |
| Covid-19 | D000086382 | — | — | 2 | 10 | 23 | 7 | 20 | 58 |
| Kidney transplantation | D016030 | — | — | 6 | 19 | 14 | 20 | 3 | 57 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | 18 | 16 | 16 | 5 | 57 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 15 | 37 | 16 | — | 7 | 67 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 11 | 34 | 17 | — | 4 | 59 |
| Myelodysplastic syndromes | D009190 | — | D46 | 10 | 39 | 2 | — | 4 | 49 |
| Multiple myeloma | D009101 | — | C90.0 | 10 | 21 | 8 | — | 6 | 44 |
| Preleukemia | D011289 | — | — | 9 | 32 | 2 | — | 4 | 42 |
| Plasma cell neoplasms | D054219 | — | — | 8 | 18 | 8 | — | 6 | 40 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 8 | 15 | 2 | — | — | 19 |
| Alcoholic hepatitis | D006519 | EFO_1001345 | K70.1 | 1 | 6 | 7 | — | 6 | 19 |
| Myeloid leukemia | D007951 | — | C92 | 7 | 14 | 2 | — | — | 18 |
| Plasmacytoma | D010954 | — | C90.3 | 3 | 9 | 2 | — | 4 | 18 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | — | D47.1 | 5 | 17 | — | — | 2 | 22 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | 11 | — | — | 2 | 14 |
| T-cell lymphoma | D016399 | — | — | 5 | 9 | — | — | — | 11 |
| T-cell lymphoma peripheral | D016411 | — | — | 4 | 7 | — | — | — | 8 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 3 | 6 | — | — | 1 | 8 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 7 | — | — | — | 7 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 2 | 2 | — | — | 3 | 6 |
| Necrosis | D009336 | — | — | — | 5 | — | — | 1 | 6 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | 5 | — | — | — | 6 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 3 | 5 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | 1 | — | — | — | 4 | 5 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | 1 | — | — | — | 2 | 3 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Precancerous conditions | D011230 | — | — | 2 | — | — | — | — | 2 |
| Ataxia | D001259 | — | R27.0 | 2 | — | — | — | — | 2 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 2 | — | — | — | — | 2 |
| Cerebellar ataxia | D002524 | HP_0001251 | — | 2 | — | — | — | — | 2 |
| Retinal perforations | D012167 | EFO_1001028 | — | 1 | — | — | — | 1 | 2 |
| Tinnitus | D014012 | HP_0000360 | H93.1 | 1 | — | — | — | 1 | 2 |
| Blister | D001768 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 3 | 3 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Wound healing | D014945 | GO_0042060 | — | — | — | — | — | 3 | 3 |
| Granulomatous mastitis | D058890 | — | N61.2 | — | — | — | — | 2 | 2 |
| Mastitis | D008413 | EFO_1001034 | N61 | — | — | — | — | 2 | 2 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 2 | 2 |
| Muscle cramp | D009120 | HP_0003394 | — | — | — | — | — | 2 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prednisolone tebutate |
| INN | prednisolone |
| Description | Prednisolone tebutate is a corticosteroid hormone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives); prednisone and prednisolone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(C)CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 7681-14-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200909 |
| ChEBI ID | 8381 |
| PubChem CID | 93055 |
| DrugBank | DB14632 |
| UNII ID | 9PHQ9Y1OLM (ChemIDplus, GSRS) |
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142,415 adverse events reported
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