Cutivate, Avamys(fluticasone propionate)
Advair, Airduo, Armonair, Avamys, Dymista, Ellipta, Flonase, Flovent, Spiromax, Xhance (fluticasone propionate) is a small molecule pharmaceutical. Fluticasone propionate was first approved as Cutivate on 1990-12-14. It is used to treat allergic rhinitis perennial in the USA. It has been approved in Europe to treat allergic rhinitis perennial, allergic rhinitis seasonal, asthma, and chronic obstructive pulmonary disease. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor and progesterone receptor.
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Commercial
Trade Name
FDA
EMA
Armonair, Arnuity ellipta, Flonase, Flonase sensimist, Flovent, Xhance (generic drugs available since 2004-05-14, discontinued: Cutivate)
CombinationsAdvair, Airduo, Breo ellipta, Dymista, Trelegy ellipta (generic drugs available since 2004-05-14)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azelastine hydrochloride
+
Fluticasone propionate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DYMISTA | Mylan | N-202236 RX | 2012-05-01 | 1 products, RLD, RS |
Fluticasone furoate
Fluticasone furoate
+
Umeclidinium bromide
+
Vilanterol trifenatate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TRELEGY ELLIPTA | GSK | N-209482 RX | 2017-09-18 | 2 products, RLD, RS |
Fluticasone furoate
+
Vilanterol trifenatate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BREO ELLIPTA | GSK | N-204275 RX | 2013-05-10 | 3 products, RLD, RS |
Fluticasone propionate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
FLOVENT DISKUS 50 | GSK | N-020833 RX | 2000-09-29 | 1 products, RLD, RS |
FLOVENT DISKUS 100 | GSK | N-020833 RX | 2000-09-29 | 1 products, RLD, RS |
FLOVENT DISKUS 250 | GSK | N-020833 RX | 2000-09-29 | 1 products, RLD, RS |
FLOVENT HFA | GSK | N-021433 RX | 2004-05-14 | 3 products, RLD, RS |
FLONASE ALLERGY RELIEF | GSK | N-205434 OTC | 2014-07-23 | 1 products, RLD |
XHANCE | OptiNose | N-209022 RX | 2017-09-18 | 1 products, RLD, RS |
ARMONAIR DIGIHALER | Teva | N-208798 RX | 2020-02-20 | 4 products, RLD, RS |
ARMONAIR RESPICLICK | Teva | N-208798 PEND | 2021-07-09 | 1 products, RLD |
Show 7 discontinued
Fluticasone propionate
+
Salmeterol xinafoate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ADVAIR DISKUS 100/50 | GSK | N-021077 RX | 2000-08-24 | 1 products, RLD, RS |
ADVAIR DISKUS 250/50 | GSK | N-021077 RX | 2000-08-24 | 1 products, RLD, RS |
ADVAIR DISKUS 500/50 | GSK | N-021077 RX | 2000-08-24 | 1 products, RLD, RS |
ADVAIR HFA | GSK | N-021254 RX | 2006-06-08 | 3 products, RLD, RS |
AIRDUO DIGIHALER | Teva | N-208799 RX | 2019-07-12 | 3 products, RLD |
AIRDUO RESPICLICK | Teva | N-208799 RX | 2017-01-27 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
advair hfa | New Drug Application | 2021-08-25 |
airduo respiclick | New Drug Application | 2020-11-23 |
armonair digihaler | New Drug Application | 2020-06-22 |
arnuity ellipta | New Drug Application | 2020-02-10 |
breo ellipta | New Drug Application | 2021-07-26 |
cutivate | New Drug Application | 2013-06-25 |
dymista | New Drug Application | 2021-04-07 |
flonase sensimist | New Drug Application | 2023-04-20 |
flovent | New Drug Application | 2023-06-07 |
trelegy ellipta | New Drug Application | 2020-09-09 |
Show 3 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
FLUTICASONE FUROATE / VILANTEROL TRIFENATATE, BREO ELLIPTA, GLAXO GRP LTD | |||
2026-05-13 | NPP, NS | ||
FLUTICASONE FUROATE, ARNUITY ELLIPTA, GLAXOSMITHKLINE | |||
2026-03-01 | M-290 | ||
FLUTICASONE PROPIONATE, ARMONAIR DIGIHALER, TEVA PHARM | |||
2025-01-09 | PED | ||
2024-07-09 | NPP, NS | ||
FLUTICASONE PROPIONATE, ARMONAIR RESPICLICK, TEVA PHARM | |||
2025-01-09 | PED | ||
2024-07-09 | NPP, NS | ||
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO DIGIHALER, TEVA PHARM | |||
2025-01-09 | PED | ||
2024-07-09 | M-61 | ||
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO RESPICLICK, TEVA PHARM | |||
2025-01-09 | PED | ||
2024-07-09 | M-61 | ||
FLUTICASONE FUROATE / UMECLIDINIUM BROMIDE / VILANTEROL TRIFENATATE, TRELEGY ELLIPTA, GLAXOSMITHKLINE | |||
2023-09-09 | I-843, NS |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Fluticasone Propionate, Armonair Digihaler, Teva Pharm | |||
11266796 | 2041-02-22 | DP | |
11173259 | 2040-07-06 | DP | |
11464923 | 2040-06-19 | DP | |
11439777 | 2040-05-24 | DP | |
11344685 | 2039-09-26 | DP | |
11000653 | 2038-12-18 | DP | |
11357935 | 2038-09-24 | DP | |
11351317 | 2038-02-10 | DP | |
10569034 | 2036-08-16 | DP | |
10918816 | 2035-12-14 | DP | |
9782550 | 2035-08-28 | DP | |
9782551 | 2035-08-28 | DP | |
8714149 | 2032-02-25 | DP | |
8978966 | 2032-01-13 | DP | |
10561808 | 2032-01-01 | DP | |
9216260 | 2031-06-28 | DP | |
9731087 | 2031-05-18 | DP | |
10022510 | 2031-05-18 | DP | |
10124131 | 2031-05-18 | DP | |
10195375 | 2031-02-14 | DP | |
8651103 | 2028-03-26 | DP | |
9463288 | 2025-05-19 | DP | |
10765820 | 2025-05-19 | DP | |
9616024 | 2024-09-01 | DP | |
7540282 | 2023-05-06 | DP | |
Fluticasone Propionate, Xhance, Optinose Us Inc | |||
11554229 | 2036-02-23 | U-2133 | |
10300229 | 2035-07-07 | DP | U-2133 |
10076614 | 2034-10-20 | DP | |
10478574 | 2033-11-04 | U-2133 | |
10179216 | 2033-07-08 | DP | U-2133 |
11033696 | 2033-05-20 | DP | |
10252010 | 2031-02-07 | DP | |
8978647 | 2030-12-06 | DP | |
8550073 | 2029-10-22 | DP | |
10076615 | 2029-07-30 | U-2133 | |
11602603 | 2028-10-27 | DP | U-2133 |
10124132 | 2027-03-06 | DP | U-2133 |
7975690 | 2025-12-29 | U-2133 | |
8522778 | 2024-04-20 | DP | |
8327844 | 2023-10-24 | U-2133 | |
Fluticasone Propionate / Salmeterol Xinafoate, Airduo Digihaler, Teva Pharm | |||
9066957 | 2034-10-06 | DP | U-645 |
9415008 | 2034-10-06 | DP | U-645 |
9987229 | 2024-09-01 | DP | |
Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline | |||
9750726 | 2030-11-29 | DP | |
11090294 | 2030-11-29 | U-3202 | |
7488827 | 2027-12-18 | DS, DP | |
8511304 | 2027-06-14 | DP | U-1424, U-1691, U-2954 |
8183257 | 2025-07-27 | U-2128, U-2129 | |
7439393 | 2025-05-21 | DS, DP | U-1401, U-1691, U-2099, U-2100, U-2127, U-2957 |
7498440 | 2025-04-27 | DS, DP | |
8309572 | 2025-04-27 | U-2129 | |
RE44874 | 2023-03-23 | DS, DP | U-1548, U-1691, U-2127, U-2955 |
Fluticasone Furoate, Arnuity Ellipta, Glaxosmithkline | |||
8746242 | 2030-10-11 | DP | |
8534281 | 2030-03-08 | DP | |
8201556 | 2029-02-05 | DP | |
8161968 | 2028-02-05 | DP | |
8113199 | 2027-10-23 | DP | |
9333310 | 2027-10-02 | DP | |
Fluticasone Furoate / Vilanterol Trifenatate, Breo Ellipta, Glaxo Grp Ltd | |||
11116721 | 2029-02-26 | DP | U-1401, U-1691 |
Fluticasone Furoate, Flonase Sensimist Allergy Relief, Glaxosmithkline Cons | |||
8147461 | 2028-10-15 | DP | |
8347879 | 2028-07-15 | DP | |
8062264 | 2026-04-05 | DP | |
8752543 | 2026-04-05 | DP | |
9320862 | 2024-11-06 | DP | |
Fluticasone Propionate, Flovent Hfa, Glaxo Grp Ltd | |||
7500444 | 2026-02-26 | DP | |
7832351 | 2023-06-19 | DP | |
Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp | |||
8168620 | 2026-02-24 | DP | |
8163723 | 2023-08-29 | U-77, U-81, U-644, U-707, U-1667 | |
9259428 | 2023-06-13 | U-644 | |
9901585 | 2023-06-13 | DP |
ATC Codes
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AC: Corticosteroids, potent (group iii)
— D07AC17: Fluticasone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD08: Fluticasone
— R01AD12: Fluticasone furoate
— R01AD58: Fluticasone, combinations
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK06: Salmeterol and fluticasone
— R03AK10: Vilanterol and fluticasone furoate
— R03AK11: Formoterol and fluticasone
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL08: Vilanterol, umeclidinium bromide and fluticasone furoate
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA05: Fluticasone
— R03BA09: Fluticasone furoate
HCPCS
No data
Clinical
Clinical Trials
593 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 | 30 | 46 | 84 | 73 | 39 | 271 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 9 | 12 | 41 | 57 | 23 | 141 |
Allergic rhinitis | D065631 | J30.9 | 5 | 3 | 6 | 19 | 3 | 36 | |
Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 7 | 13 | 9 | 5 | 34 |
Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | 1 | 1 | 5 | 6 | 3 | 16 |
Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 4 | 4 | 4 | 2 | 12 |
Healthy volunteers/patients | — | 5 | — | — | 2 | 3 | 10 | ||
Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | 3 | 2 | 1 | 7 |
Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | 5 | — | 7 |
Nasal polyps | D009298 | HP_0100582 | J33 | 1 | 1 | 2 | 2 | 1 | 6 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Rhinitis | D012220 | EFO_0008521 | J31 | — | — | 3 | — | 3 | 6 |
Conjunctivitis | D003231 | H10 | — | — | 2 | — | — | 2 | |
Gastrointestinal diseases | D005767 | — | 2 | 2 | — | — | 2 | ||
Polyps | D011127 | EFO_0000662 | — | — | 1 | — | 1 | 2 | |
Covid-19 | D000086382 | U07.1 | — | 1 | 2 | — | — | 2 | |
Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | — | 1 | — | — | 1 |
Exercise-induced asthma | D001250 | J45.990 | — | — | 1 | — | — | 1 | |
Croup | D003440 | EFO_0007227 | J05.0 | — | — | 1 | — | — | 1 |
Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | — | 1 |
Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | 1 | 2 |
Bronchiolitis obliterans | D001989 | EFO_0007183 | — | 1 | — | — | — | 1 | |
Bronchiectasis | D001987 | HP_0002110 | J47 | — | 1 | — | — | — | 1 |
Esophagitis | D004941 | HP_0100633 | K20 | — | 1 | — | — | — | 1 |
Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 1 | — | — | — | 1 |
Eczema | D004485 | HP_0000964 | L30.9 | — | 1 | — | — | — | 1 |
Pharmacokinetics | D010599 | — | 1 | — | — | — | 1 | ||
Bronchiolitis | D001988 | HP_0011950 | — | 1 | — | — | — | 1 | |
Bronchogenic carcinoma | D002283 | — | 1 | — | — | — | 1 | ||
Autism spectrum disorder | D000067877 | F84.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Therapeutic equivalency | D013810 | 9 | — | — | — | — | 9 | ||
Inflammation | D007249 | 1 | — | — | — | — | 1 | ||
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Respiration disorders | D012120 | J00-J99 | — | — | — | — | 2 | 2 | |
Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 1 | 1 |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
Vitiligo | D014820 | EFO_0004208 | L80 | — | — | — | — | 1 | 1 |
Smoking | D012907 | EFO_0003768 | F17 | — | — | — | — | 1 | 1 |
Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 | |
Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | 1 | |
Sleep wake disorders | D012893 | G47 | — | — | — | — | 1 | 1 | |
Bronchial hyperreactivity | D016535 | — | — | — | — | 1 | 1 | ||
Only child | D009863 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | FLUTICASONE PROPIONATE |
INN | fluticasone |
Description | Fluticasone propionate is a trifluorinated corticosteroid that consists of 6alpha,9-difluoro-11beta,17alpha-dihydroxy-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-16-methyl-3-oxoandrosta-1,4-diene bearing a propionyl substituent at position 17; has anti-inflammatory, anti-asthmatic and anti-allergic activity. It has a role as an anti-allergic agent, an anti-asthmatic drug, an anti-inflammatory drug, a dermatologic drug, a bronchodilator agent and an adrenergic agent. It is a corticosteroid, a steroid ester, an 11beta-hydroxy steroid, a propanoate ester, a fluorinated steroid, a thioester and a 3-oxo-Delta(1),Delta(4)-steroid. It is functionally related to a fluticasone. It derives from a hydride of an androstane. |
Classification | Small molecule |
Drug class | Steroids and steroid derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CCC(=O)O[C@]1(C(=O)SCF)[C@H](C)C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C |
Identifiers
PDB | — |
CAS-ID | 80474-14-2 |
RxCUI | 50121 |
ChEMBL ID | CHEMBL1473 |
ChEBI ID | 31441 |
PubChem CID | 444036 |
DrugBank | DB00588 |
UNII ID | CUT2W21N7U (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
NR3C2
NR3C2
PGR
PGR
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
Clinical Variant
No data
Financial
Xhance - OptiNose
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Trelegy ellipta - Innoviva, Inc.
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Dymista - Viatris
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,925 adverse events reported
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