Overview
Salmeterol is a long-acting beta-2 adrenergic receptor agonist drug that is currently prescribed for the treatment of asthma and chronic obstructive pulmonary disease COPD. It has a longer duration of action than the short-acting beta-2 adrenergic receptor agonist, salbutamol. Salmeterol was first described in the literature in 1988. Salmeterol's structure is similar to salbutamol's with an aralkyloxy-alkyl substitution on the amine. Salmeterol was granted FDA approval on 4 February 1994.
Background
Salmeterol is a long-acting beta-2 adrenergic receptor agonist drug that is currently prescribed for the treatment of asthma and chronic obstructive pulmonary disease COPD. It has a longer duration of action than the short-acting beta-2 adrenergic receptor agonist, salbutamol. Salmeterol was first described in the literature in 1988. Salmeterol's structure is similar to salbutamol's with an aralkyloxy-alkyl substitution on the amine. Salmeterol was granted FDA approval on 4 February 1994.
Indication
用于哮喘（包括夜间哮喘和运动性哮喘）、喘息性支气管炎和可逆性气道阻塞。
Associated Conditions
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Exercise-Induced Bronchospasm
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/24 | Not Applicable | Recruiting | |||
2024/10/23 | Not Applicable | Recruiting | |||
2024/10/23 | Not Applicable | Recruiting | |||
2024/02/28 | Phase 4 | Recruiting | |||
2023/03/20 | Phase 3 | Not yet recruiting | |||
2021/10/19 | N/A | Completed | |||
2020/08/07 | Phase 4 | Recruiting | |||
2019/12/12 | Phase 1 | Completed | Parc de Salut Mar | ||
2018/11/19 | Phase 3 | UNKNOWN | Henan University of Traditional Chinese Medicine | ||
2018/03/12 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GlaxoSmithKline LLC | 0173-0521 | RESPIRATORY (INHALATION), ORAL | 50 ug in 1 1 | 2/25/2022 | |
| Teva Respiratory, LLC | 59310-129 | RESPIRATORY (INHALATION) | 14 ug in 1 1 | 2/9/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3608 | RESPIRATORY (INHALATION) | 14 ug in 1 1 | 2/9/2024 | |
| Physicians Total Care, Inc. | 54868-4517 | RESPIRATORY (INHALATION), ORAL | 50 ug in 1 1 | 11/12/2010 | |
| GlaxoSmithKline LLC | 0173-0697 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 10/20/2020 | |
| Teva Respiratory, LLC | 59310-822 | RESPIRATORY (INHALATION) | 14 ug in 1 1 | 2/6/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0326 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 12/19/2023 | |
| Prasco Laboratories | 66993-584 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 1/7/2019 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7516 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 9/28/2022 | |
| Prasco Laboratories | 66993-088 | RESPIRATORY (INHALATION) | 21 ug in 1 1 | 8/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 | ||
Authorised | 3/26/2021 | ||
Authorised | 3/26/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SALFLUMIX EASYHALER INHALATION POWDER 50µG/250µG/DOSE | SIN16909P | POWDER, METERED | 50µg/dose | 12/13/2023 | |
| SERETIDE 50/250 ACCUHALER 50 mcg/250 mcg | SIN11031P | POWDER, METERED | 50 mcg/inhalation | 7/19/1999 | |
| SERETIDE EVOHALER 25/250 mcg | SIN11531P | AEROSOL, SPRAY | 25 mcg | 5/24/2001 | |
| SERETIDE EVOHALER 25/50 mcg | SIN11529P | AEROSOL, SPRAY | 25 mcg | 5/24/2001 | |
| SERETIDE 50/500 ACCUHALER 50 mcg/500 mcg | SIN11032P | POWDER, METERED | 50 mcg/inhalation | 7/19/1999 | |
| SERETIDE EVOHALER 25/125 mcg | SIN11530P | AEROSOL, SPRAY | 25 mcg | 5/24/2001 | |
| SALFLUMIX EASYHALER INHALATION POWDER 50µG/500µG/DOSE | SIN16910P | POWDER, METERED | 50µg/dose | 12/13/2023 | |
| SERETIDE 50/100 ACCUHALER 50 mcg/100 mcg | SIN11030P | POWDER, METERED | 50 mcg/inhalation | 7/19/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Salmeterol Xinafoate Aerosol | 国药准字H20010584 | 化学药品 | 气雾剂 | 12/8/2020 | |
| Salmeterol Xinafoate Aerosol | 国药准字H20052614 | 化学药品 | 气雾剂 | 5/20/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SERETIDE INHALER 25/50 | N/A | N/A | N/A | 6/29/2001 | |
| SEROFLO 125 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| SEROFLO 250 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| SERETIDE ACCUHALER 50MCG/250MCG | N/A | N/A | N/A | 4/26/1999 | |
| SEROFLO 500 MULTI-HALER POWDER FOR INHALATION 50MCG/500MCG | N/A | N/A | N/A | 10/20/2014 | |
| SEREVENT INHALER 25MCG/ACTUATION | N/A | N/A | N/A | 4/8/1992 | |
| SERETIDE INHALER 25/250 | N/A | N/A | N/A | 6/29/2001 | |
| SERETIDE INHALER 25/125 | N/A | N/A | N/A | 6/29/2001 | |
| SEROFLO 50 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| SERETIDE ACCUHALER 50MCG/500MCG | N/A | N/A | N/A | 4/26/1999 |