Ciclesonide
Alvesco, Omnaris (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
Therapeutic Areas
Trade Name
FDA
EMA
Alvesco, Omnaris (discontinued: Zetonna)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ciclesonide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALVESCO | Covis Pharma | N-021658 RX | 2008-01-10 | 2 products, RLD, RS |
| OMNARIS | Covis Pharma | N-022004 RX | 2006-10-20 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis seasonal | EFO_0003956 | D006255 | J30 |
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
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
96 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | — | 9 | 25 | 9 | 6 | 49 |
| Allergic rhinitis | D065631 | — | J30.9 | 2 | 1 | 24 | 6 | — | 33 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 1 | 23 | 6 | 1 | 32 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 14 | 2 | — | 16 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | 1 | 1 | 1 | 3 |
| Respiratory hypersensitivity | D012130 | — | — | — | — | 1 | 2 | — | 3 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | 1 | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | — | — | 1 | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | 1 | — | 1 |
| Bronchial diseases | D001982 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 15 | — | 1 | 17 |
| Covid-19 | D000086382 | — | U07.1 | — | 5 | 4 | — | — | 6 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | — | 2 | 1 | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | 1 | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | 1 | — | — | 1 |
| Polyps | D011127 | EFO_0000662 | — | — | — | 1 | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | 1 | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 1 | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 1 | 1 |
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 | — |
| 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
No data
Financial
Revenue by drug
$
€
£
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No data
Estimated US medical usage
Ciclesonide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,123 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,610 adverse events reported
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