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
Trade Name
FDA
EMA
Serevent
CombinationsAdvair, 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 100/50 | 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 |
Salmeterol xinafoate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
SEREVENT | GSK | N-020692 RX | 1997-09-19 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
advair hfa | New Drug Application | 2021-08-25 |
airduo respiclick | New Drug Application | 2020-11-23 |
serevent | New Drug Application | 2020-01-13 |
wixela inhub | ANDA | 2023-03-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
asthma | EFO_0000270 | D001249 | J45 |
bronchial spasm | — | D001986 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
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 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Fluticasone Propionate / Salmeterol Xinafoate, Airduo 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 | |
9066957 | 2034-10-06 | DP | U-645 |
9415008 | 2034-10-06 | DP | U-645 |
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 | |
9987229 | 2024-09-01 | DP | |
7540282 | 2023-05-06 | DP | |
Fluticasone Propionate / Salmeterol Xinafoate, Advair Hfa, Glaxo Grp Ltd | |||
7500444 | 2026-02-26 | DP | |
7832351 | 2023-06-19 | DP |
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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-small-cell lung carcinoma | D002289 | 86 | 222 | 136 | 9 | 13 | 431 | ||
Head and neck neoplasms | D006258 | 56 | 132 | 51 | 1 | 6 | 222 | ||
Squamous cell carcinoma of head and neck | D000077195 | 46 | 87 | 36 | 1 | 8 | 161 | ||
Uterine cervical neoplasms | D002583 | 35 | 63 | 54 | 1 | 11 | 153 | ||
Esophageal neoplasms | D004938 | C15 | 20 | 89 | 39 | 2 | 6 | 138 | |
Small cell lung carcinoma | D055752 | 20 | 32 | 21 | 1 | 1 | 66 | ||
Squamous cell neoplasms | D018307 | 15 | 37 | 10 | 1 | 3 | 58 | ||
Melanoma | D008545 | 12 | 12 | 6 | 1 | — | 27 | ||
Adenocarcinoma of lung | D000077192 | 5 | 10 | 2 | 1 | 2 | 20 | ||
Germ cell and embryonal neoplasms | D009373 | — | 8 | 7 | 1 | 1 | 17 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung neoplasms | D008175 | C34.90 | 40 | 109 | 53 | — | 3 | 188 | |
Neoplasms | D009369 | C80 | 126 | 54 | 13 | — | 5 | 176 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 34 | 99 | 42 | — | 5 | 164 |
Nasopharyngeal neoplasms | D009303 | 8 | 64 | 54 | — | 10 | 125 | ||
Urinary bladder neoplasms | D001749 | C67 | 21 | 65 | 19 | — | 4 | 98 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 20 | 61 | 9 | — | 5 | 84 |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 32 | 37 | 18 | — | 3 | 83 |
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 27 | 47 | 6 | — | 1 | 70 |
Esophageal squamous cell carcinoma | D000077277 | 1 | 40 | 21 | — | 2 | 61 | ||
Cholangiocarcinoma | D018281 | C22.1 | 19 | 30 | 11 | — | 4 | 56 |
Show 112 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Peritoneal neoplasms | D010534 | 9 | 10 | — | — | 1 | 19 | ||
Gastrointestinal neoplasms | D005770 | C26.9 | 3 | 6 | — | — | — | 8 | |
Large b-cell lymphoma diffuse | D016403 | C83.3 | 2 | 6 | — | — | — | 7 | |
Thymus neoplasms | D013953 | C37 | 1 | 4 | — | — | — | 4 | |
B-cell lymphoma | D016393 | 4 | 1 | — | — | — | 4 | ||
Penile neoplasms | D010412 | C60 | 1 | 3 | — | — | — | 4 | |
Chondrosarcoma | D002813 | 3 | 1 | — | — | — | 3 | ||
Digestive system neoplasms | D004067 | 2 | 2 | — | — | — | 3 | ||
Adenosquamous carcinoma | D018196 | — | 3 | — | — | — | 3 | ||
Papillomaviridae | D027383 | — | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Brenner tumor | D001948 | 3 | — | — | — | 1 | 4 | ||
Cystadenocarcinoma | D003536 | 2 | — | — | — | 1 | 3 | ||
Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | 2 | — | — | — | — | 2 |
Rhabdomyosarcoma | D012208 | 2 | — | — | — | — | 2 | ||
Desmoplastic small round cell tumor | D058405 | 2 | — | — | — | — | 2 | ||
Klatskin tumor | D018285 | EFO_1001005 | 2 | — | — | — | — | 2 | |
Ampulla of vater cancer | — | 2 | — | — | — | — | 2 | ||
Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
Pinealoma | D010871 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Circulating neoplastic cells | D009360 | — | — | — | — | 2 | 2 | ||
Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
Cervical intraepithelial neoplasia | D018290 | D06 | — | — | — | — | 2 | 2 | |
Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | 1 | 1 | |
Prognosis | D011379 | — | — | — | — | 1 | 1 | ||
Nutritional support | D018529 | — | — | — | — | 1 | 1 | ||
Virus diseases | D014777 | B34 | — | — | — | — | 1 | 1 | |
Tumor virus infections | D014412 | — | — | — | — | 1 | 1 | ||
Otorhinolaryngologic diseases | D010038 | — | — | — | — | 1 | 1 | ||
Dna virus infections | D004266 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | SALMETEROL XINAFOATE |
INN | salmeterol |
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 class | anti-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-ID | 89365-50-4 |
RxCUI | 36117 |
ChEMBL ID | CHEMBL1082607 |
ChEBI ID | — |
PubChem CID | 5152 |
DrugBank | DB00938 |
UNII ID | 2I4BC502BT (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:
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Safety
Black-box Warning
Black-box warning for: Serevent
Adverse Events
Top Adverse Reactions
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52,766 adverse events reported
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