Drugs / salmeterol xinafoate
salmeterol xinafoate
also known as
Serevent · Serevent Diskus · Salmeterol · Salmeterol xinafoate/fluticasone propionate combination
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Aerivio Spiromax | — | 2016-08-18 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | SEREVENT | — | 1998-02-05 – 2002-03-22 | fda.gov ↗ |
| Approved | US (FDA) | SEREVENT | — | 1994-02-04 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02260492 | Sep 2014 → May 2015 | asthma | Oriel Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02254174 | Mar → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01772368 | Jan → Jun 2013 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01712451 | Aug 2011 → Oct 2012 | — | Neothetics, Inc | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT02245672 | Oct 2014 → Jul 2015 | asthma | Mylan Pharma UK Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02139644 | Jun 2014 → Sep 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02141854 | Jun 2014 → Sep 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00565266 | May 2008 → May 2010 | asthma | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00394368 | Nov 2004 → Sep 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT00546234 | Nov 2007 → Jan 2014 | asthma | University of Alberta | Withdrawn | No outcome recorded |
| Phase 4 | NCT00461500 | Mar → Dec 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT02433834 Comparator | May 2015 → Mar 2016 | asthma | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00403286 Comparator | Nov 2006 → May 2007 | chronic obstructive pulmonary disease | Dey | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02554786 Comparator | Dec 2015 → Nov 2018 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02571777 Comparator | Dec 2015 → Jun 2019 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00628758 Background | Dec 2005 → Sep 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06282861 Comparator | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Launches Two Digital Inhalers in the U.S., AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder tevapharm.com ↗ |
| 2019-07-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder tevapharm.com ↗ |
| 2017-04-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Launches AirDuo™ RespiClick® and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol tevapharm.com ↗ |
| 2016-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers tevapharm.com ↗ |
| 2015-11-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma tevapharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | salmeterol xinafoate | “FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate...” NCT02139644 ↗10“FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and...” NCT02141854 ↗ “FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and...” NCT01772368 ↗ “Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®” NCT02571777 ↗ |
| Known as | Salmeterol | “50 μg Salmeterol [Serevent® Diskus®]” NCT02254174 ↗ |
| Known as | Salmeterol xinafoate/fluticasone propionate combination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00461500 ↗ |
| Known as | Serevent | “Serevent diskus 50 mcg/dosage, 60 dosage” NCT00628758 ↗ |
| Known as | Serevent Diskus | “Serevent Diskus 50 μg” NCT02433834 ↗ |
| Action | Activate | “β2 adrenoceptor agonist” NCT01772368 ↗ |
| Route | Inhaled | “both delivered two inhalations b.i.d. via a pressurized metered dose inhaler.” PMID 17845589 ↗ Oct 2007 |