Salmeterol
Advair, Airduo, Fluticasone / Salmeterol Xinafoate, Serevent, Spiromax, Wixela (salmeterol) is a small molecule pharmaceutical. Salmeterol 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. The pharmaceutical is active against beta-2 adrenergic receptor.
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| advair | New Drug Application | 2023-06-30 |
| advair diskus | New Drug Application | 2024-01-30 |
| advair hfa | New Drug Application | 2024-05-23 |
| airduo digihaler | New Drug Application | 2024-04-29 |
| airduo respiclick | New Drug Application | 2024-02-06 |
| fluticasone propionate and salmeterol | ANDA | 2024-07-23 |
| fluticasone propionate and salmeterol hfa | NDA authorized generic | 2024-05-29 |
| serevent | New Drug Application | 2022-10-10 |
| wixela inhub | ANDA | 2024-03-01 |
Indications
FDA
EMA
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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 | |
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
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Clinical
Clinical Trials
423 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 | 23 | 23 | 59 | 67 | 39 | 210 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 11 | 25 | 56 | 54 | 31 | 175 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 3 | 14 | 46 | 34 | 19 | 115 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 4 | 16 | 35 | 39 | 22 | 114 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 13 | 2 | 11 | 1 | 1 | 28 |
| Healthy volunteers/patients | — | — | — | 7 | — | — | 1 | 4 | 12 |
| Bronchitis | D001991 | — | J40 | — | — | 4 | 1 | 1 | 6 |
| Allergic rhinitis | D065631 | — | J30.9 | — | — | 1 | 3 | 1 | 5 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | 1 | 3 | 1 | 5 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | 3 | 1 | 1 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract diseases | D012140 | — | — | — | — | 1 | — | 2 | 3 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | 1 | — | 2 | 3 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | — | 1 | — | 1 | 2 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | — | — | — | 1 | — | — | 1 |
| Bronchiolitis | D001988 | HP_0011950 | — | — | — | 1 | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | — | — | 1 | — | — | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | 1 | — | — | 1 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary eosinophilia | D011657 | EFO_0007257 | J82.81 | — | 1 | — | — | — | 1 |
| Edema | D004487 | HP_0000969 | R60.9 | 1 | 1 | — | — | — | 1 |
| Pulmonary edema | D011654 | EFO_1001134 | J81 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 14 | — | — | — | — | 14 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Respiratory signs and symptoms | D012818 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | — | — | 1 | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Nebulizers and vaporizers | D009330 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Salmeterol |
| 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) | OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O |
Identifiers
| PDB | — |
| CAS-ID | 89365-50-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1263 |
| ChEBI ID | 64064 |
| PubChem CID | 5152 |
| DrugBank | DB00938 |
| UNII ID | 2I4BC502BT (ChemIDplus, GSRS) |
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Salmeterol
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Fluticasone
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Salmeterol
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Safety
Black-box Warning
Black-box warning for: Serevent
Adverse Events
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73,939 adverse events reported
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