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Serevent, Aerivio spiromax(salmeterol xinafoate)
Advair, Airduo, Serevent, Spiromax (salmeterol xinafoate) is a small molecule pharmaceutical. Salmeterol xinafoate was first approved as Serevent on 1994-02-04. It is used to treat asthma and bronchial spasm in the USA. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease. It is known to target beta-2 adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Serevent
Combinations
Advair, Airduo (generic drugs available since 2019-01-30)
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 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
ADVAIR HFAGSKN-021254 RX2006-06-08
3 products, RLD, RS
AIRDUO DIGIHALERTevaN-208799 RX2019-07-12
3 products, RLD
AIRDUO RESPICLICKTevaN-208799 RX2017-01-27
3 products, RLD, RS
Salmeterol xinafoate
Tradename
Company
Number
Date
Products
SEREVENTGSKN-020692 RX1997-09-19
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
advair hfaNew Drug Application2021-08-25
airduo respiclickNew Drug Application2020-11-23
sereventNew Drug Application2020-01-13
wixela inhubANDA2023-03-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
Agency Specific
FDA
EMA
Expiration
Code
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 / Salmeterol Xinafoate, Airduo 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
90669572034-10-06DPU-645
94150082034-10-06DPU-645
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
99872292024-09-01DP
75402822023-05-06DP
Fluticasone Propionate / Salmeterol Xinafoate, Advair Hfa, Glaxo Grp Ltd
75004442026-02-26DP
78323512023-06-19DP
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AC: Selective beta-2-adrenoreceptor agonist inhalants
— R03AC12: Salmeterol
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK06: Salmeterol and fluticasone
— R03AK12: Salmeterol and budesonide
HCPCS
No data
Clinical
Clinical Trials
2875 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228986222136913431
Head and neck neoplasmsD006258561325116222
Squamous cell carcinoma of head and neckD00007719546873618161
Uterine cervical neoplasmsD002583356354111153
Esophageal neoplasmsD004938C1520893926138
Small cell lung carcinomaD0557522032211166
Squamous cell neoplasmsD0183071537101358
MelanomaD008545121261—27
Adenocarcinoma of lungD00007719251021220
Germ cell and embryonal neoplasmsD009373—871117
Show 8 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175C34.904010953—3188
NeoplasmsD009369C801265413—5176
Stomach neoplasmsD013274EFO_0003897C16349942—5164
Nasopharyngeal neoplasmsD00930386454—10125
Urinary bladder neoplasmsD001749C67216519—498
Breast neoplasmsD001943EFO_0003869C5020619—584
Ovarian neoplasmsD010051EFO_0003893C56323718—383
Pancreatic neoplasmsD010190EFO_0003860C2527476—170
Esophageal squamous cell carcinomaD00007727714021—261
CholangiocarcinomaD018281C22.1193011—456
Show 112 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peritoneal neoplasmsD010534910——119
Gastrointestinal neoplasmsD005770C26.936———8
Large b-cell lymphoma diffuseD016403C83.326———7
Thymus neoplasmsD013953C3714———4
B-cell lymphomaD01639341———4
Penile neoplasmsD010412C6013———4
ChondrosarcomaD00281331———3
Digestive system neoplasmsD00406722———3
Adenosquamous carcinomaD018196—3———3
PapillomaviridaeD027383—3———3
Show 59 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brenner tumorD0019483———14
CystadenocarcinomaD0035362———13
Appendiceal neoplasmsD001063EFO_0003880C18.12————2
RhabdomyosarcomaD0122082————2
Desmoplastic small round cell tumorD0584052————2
Klatskin tumorD018285EFO_10010052————2
Ampulla of vater cancer—2————2
Castration-resistant prostatic neoplasmsD0641291————1
Autonomic nervous system diseasesD001342EFO_0009532G901————1
PinealomaD0108711————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Circulating neoplastic cellsD009360————22
MalnutritionD044342EFO_0008572E40-E46————22
Cervical intraepithelial neoplasiaD018290D06————22
Liver transplantationD016031EFO_0010682————11
PrognosisD011379————11
Nutritional supportD018529————11
Virus diseasesD014777B34————11
Tumor virus infectionsD014412————11
Otorhinolaryngologic diseasesD010038————11
Dna virus infectionsD004266————11
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSALMETEROL XINAFOATE
INNsalmeterol
Description
2-(hydroxymethyl)-4-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)phenol is a phenol having a hydroxymethyl group at C-2 and a 1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl group at C-4; derivative of phenylethanolamine. It is a member of phenols, an ether, a secondary alcohol, a primary alcohol and a secondary amino compound. It is functionally related to a phenylethanolamine.
Classification
Small molecule
Drug classanti-inflammatory agents (salicylic acid derivatives); bronchodilators (phenethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(O)c1ccc2ccccc2c1O.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Identifiers
PDB—
CAS-ID89365-50-4
RxCUI36117
ChEMBL IDCHEMBL1082607
ChEBI ID—
PubChem CID5152
DrugBankDB00938
UNII ID2I4BC502BT (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,366 documents
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Safety
Black-box Warning
Black-box warning for: Serevent
Adverse Events
Top Adverse Reactions
Mock data
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52,766 adverse events reported
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