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Drug ReportsFluticasone
Cutivate, Aerivio spiromax(fluticasone propionate)
/ Fluticasone, Advair, Airduo, Avamys, Dymista, Ellipta, Flonase, Flovent, Fluticasone, Fluticasone /, Spiromax, Wixela, 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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Flonase, Flovent, Fluticasone, Xhance (discontinued: Armonair, Cutivate, Flonase, Flovent, Fluticasone)
Combinations
Advair, Airduo, Azelastine fluticasone, Dymista, Fluticasone salmeterol xinafoate, Wixela (discontinued: Airduo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluticasone propionate
+
Salmeterol xinafoate
Tradename
Company
Number
Date
Products
ADVAIR HFAGSKN-021254 RX2006-06-08
3 products, RLD, RS
ADVAIR DISKUS 100/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
ADVAIR DISKUS 250/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
ADVAIR DISKUS 500/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
AIRDUO RESPICLICKTevaN-208799 RX2017-01-27
3 products, RLD, RS
Show 1 discontinued
Fluticasone propionate
Tradename
Company
Number
Date
Products
FLOVENT HFAGSKN-021433 RX2004-05-14
3 products, RLD, RS
FLOVENT DISKUS 50GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLOVENT DISKUS 100GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLOVENT DISKUS 250GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLONASE ALLERGY RELIEFGSKN-205434 OTC2014-07-23
1 products, RLD
XHANCEOptiNoseN-209022 RX2017-09-18
1 products, RLD, RS
Show 10 discontinued
Azelastine hydrochloride
+
Fluticasone propionate
Tradename
Company
Number
Date
Products
DYMISTAMylanN-202236 RX2012-05-01
1 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
24 hour allergy nasalANDA2023-10-11
advairNew Drug Application2023-06-30
advair diskusNew Drug Application2024-01-30
advair hfaNew Drug Application2024-05-23
airduo digihalerNew Drug Application2024-04-29
airduo respiclickNew Drug Application2024-02-06
allergy nasalANDA2024-12-18
allergy reliefANDA2024-10-02
allergy relief nasalANDA2024-11-27
armonair digihalerNew Drug Application2024-04-29
Show 60 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
allergic rhinitis perennialEFO_1001417D012221J30.89
bronchial spasm—D001986—
allergic conjunctivitisEFO_0007141D003233H10.44
vasomotor rhinitisEFO_0007533D012223J30.0
Agency Specific
FDA
EMA
Expiration
Code
FLUTICASONE FUROATE / VILANTEROL TRIFENATATE, BREO ELLIPTA, GLAXO GRP LTD
2026-11-13PED
2026-05-13NPP, NS
FLUTICASONE FUROATE, ARNUITY ELLIPTA, GLAXOSMITHKLINE
2026-03-01M-290
FLUTICASONE PROPIONATE, ARMONAIR DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE, ARMONAIR RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09M-61
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09M-61
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluticasone Propionate, Armonair Digihaler, Teva Pharm
112667962041-02-22DP
111732592040-07-06DP
114649232040-06-19DP
114397772040-05-24DP
113446852039-09-26DP
110006532038-12-18DP
113579352038-09-24DP
113513172038-02-10DP
105690342036-08-16DP
109188162035-12-14DP
97825502035-08-28DP
97825512035-08-28DP
87141492032-02-25DP
89789662032-01-13DP
105618082032-01-01DP
92162602031-06-28DP
97310872031-05-18DP
100225102031-05-18DP
101241312031-05-18DP
101953752031-02-14DP
86511032028-03-26DP
94632882025-05-19DP
107658202025-05-19DP
96160242024-09-01DP
Fluticasone Propionate, Xhance, Optinose Us Inc
115542292036-02-23U-2133
103002292035-07-07DPU-2133
100766142034-10-20DP
104785742033-11-04U-2133
101792162033-07-08DPU-2133
110336962033-05-20DP
102520102031-02-07DP
89786472030-12-06DP
85500732029-10-22DP
100766152029-07-30U-2133
116026032028-10-27DPU-2133
101241322027-03-06DPU-2133
79756902025-12-29U-2133
85227782024-04-20DP
Fluticasone Propionate / Salmeterol Xinafoate, Airduo Digihaler, Teva Pharm
90669572034-10-06DPU-645
94150082034-10-06DPU-645
99872292024-09-01DP
Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline
97507262030-11-29DP
110902942030-11-29U-3202
85342812030-03-08DP
81619682028-02-05DP
74888272027-12-18DS, DP
85113042027-06-14DPU-1424, U-1691, U-2954, U-3623
81832572025-07-27U-2128, U-2129
74393932025-05-21DS, DPU-1401, U-1691, U-2099, U-2100, U-2127, U-2957, U-3623
74984402025-04-27DS, DP
83095722025-04-27U-2129
Fluticasone Furoate, Arnuity Ellipta, Glaxosmithkline
87462422030-10-11DP
82015562029-02-05DP
93333102027-10-02DP
Fluticasone Furoate / Vilanterol Trifenatate, Breo Ellipta, Glaxo Grp Ltd
111167212029-02-26DPU-1401, U-1691, U-3623
Fluticasone Furoate, Flonase Sensimist Allergy Relief, Haleon Us Holdings
81474612028-10-15DP
83478792028-07-15DP
80622642026-04-05DP
93208622024-11-06DP
Fluticasone Propionate, Flovent Hfa, Glaxo Grp Ltd
75004442026-02-26DP
Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp
81686202026-02-24DP
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
836 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitisD065631—J30.9——1——1
RhinitisD012220EFO_0008521J31——1——1
Allergic rhinitis seasonalD006255EFO_0003956J30——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———————22
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluticasone propionate
INNfluticasone
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 classSteroids and steroid derivatives
Image (chem structure or protein)Loading
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-ID80474-14-2
RxCUI—
ChEMBL IDCHEMBL1473
ChEBI ID31441
PubChem CID444036
DrugBankDB00588
UNII IDCUT2W21N7U (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
2908
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
Q6N0A4
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
4306
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
Q96KQ9
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xhance – OptiNose
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Dymista – Viatris
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Trelegy ellipta – Innoviva
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Tabular view
Estimated US medical usage
Fluticasone propionate
+
Fluticasone
Total medical expenditures per year (USD, in millions)
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Fluticasone propionate
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Salmeterol
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Fluticasone
Total medical expenditures per year (USD, in millions)
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Fluticasone propionate
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Umeclidinium
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Vilanterol
+
Fluticasone
Total medical expenditures per year (USD, in millions)
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Fluticasone propionate
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Vilanterol
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Fluticasone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,639 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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158,302 adverse events reported
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