Ciclesonide
Alvesco, Omnaris, Zetonna (ciclesonide) is a small molecule pharmaceutical. Ciclesonide was first approved as Omnaris on 2006-10-20. It is used to treat allergic rhinitis perennial and allergic rhinitis seasonal in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Trade Name
FDA
EMA
Alvesco, Omnaris, Zetonna
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| allergic rhinitis seasonal | EFO_0003956 | D006255 | J30 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ciclesonide, Alvesco, Covis | |||
| 8371292 | 2028-02-01 | U-1355, U-1356, U-1357 | |
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD13: Ciclesonide
— R03: Drugs for obstructive airway diseases
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA08: Ciclesonide
HCPCS
No data
Clinical
Clinical Trials
198 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | 5 | 9 | 14 | 8 | 5 | 38 | |
| Hypertriglyceridemia | D015228 | EFO_0004211 | 1 | 3 | 5 | 9 | 5 | 23 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | 2 | 8 | 3 | 3 | 16 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 5 | 5 | 3 | 14 |
| Hypercholesterolemia | D006937 | HP_0003124 | 1 | 1 | 6 | 2 | — | 10 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 2 | 4 | 8 |
| Coronary disease | D003327 | — | — | 7 | 1 | — | 8 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 2 | — | 1 | 4 | 7 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | 3 | 3 | 1 | 7 | |
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | 1 | 4 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | K74.3 | 1 | 3 | 2 | — | — | 5 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 2 | — | 2 | 4 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 2 | — | — | 3 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | 1 | 3 | |
| Hyperlipoproteinemia type v | D006954 | Orphanet_70470 | E78.3 | — | — | 1 | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | 1 | — | — | 1 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | 1 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | — | — | 1 | |
| Hyperlipoproteinemias | D006951 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 16 | 1 | — | — | 5 | 22 | ||
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | — | — | 1 | 3 |
| Medulloblastoma | D008527 | — | 1 | — | — | — | 1 | ||
| Ependymoma | D004806 | — | 1 | — | — | — | 1 | ||
| Leukemia | D007938 | C95 | — | 1 | — | — | — | 1 | |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Sarcoma | D012509 | — | 1 | — | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | 1 | |
| Huntington disease | D006816 | G10 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | — | — | — | — | 2 | 2 | ||
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Cytokinesis | D048749 | — | — | — | — | 1 | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Neonatal jaundice | D007567 | P59.9 | — | — | — | — | 1 | 1 | |
| Radiodermatitis | D011855 | L58 | — | — | — | — | 1 | 1 | |
| Diabetes complications | D048909 | — | — | — | — | 1 | 1 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CICLESONIDE |
| INN | ciclesonide |
| Description | Ciclesonide is an organic molecular entity. |
| Classification | Small molecule |
| Drug class | topical steroids (acetal derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C(=O)OCC(=O)[C@@]12O[C@H](C3CCCCC3)O[C@@H]1C[C@H]1[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]12C |
Identifiers
| PDB | — |
| CAS-ID | 126544-47-6 |
| RxCUI | 274964 |
| ChEMBL ID | CHEMBL2040682 |
| ChEBI ID | — |
| PubChem CID | 6918155 |
| DrugBank | DB01410 |
| UNII ID | S59502J185 (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
No data
Variants
Clinical Variant
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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2,495 adverse events reported
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