Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 and bioequivalence studies evaluate salmeterol xinafoate, primarily for respiratory conditions—such as asthma, COPD, and exercise-induced asthma—and localized adipose tissue reduction, including submental fat and abdominal contour defects. Sponsored by major pharmaceutical corporations (such as GlaxoSmithKline and Boehringer Ingelheim) and academic institutions (such as Imperial College London and Milton S. Hershey Medical Center), these investigations encompass recruitment statuses ranging from completed and recruiting to unknown, withdrawn, or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05776927 RECRUITING
Asthma
Novartis Pharmaceuticals
 2026-08-04 PHASE3
NCT04503460 UNKNOWN
Asthma
Imperial College London
 2021-07-23 PHASE4
NCT06025214 UNKNOWN
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2023-08-22 PHASE1
NCT05982990 UNKNOWN
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2023-08-01 PHASE1
NCT05697003 UNKNOWN
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2023-02-17 PHASE1
NCT05085587 UNKNOWN
Bioequivalence; Asthma
Respirent Pharmaceuticals Co Ltd.
 2021-10-01 PHASE1
NCT04746040 UNKNOWN
Bioequivalence; Asthma
Respirent Pharmaceuticals Co Ltd.
 2021-01-18 PHASE1
NCT04564456 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2020-09-22 PHASE1
NCT04546256 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2020-09-01 PHASE1
NCT04462822 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2020-08-24 PHASE1
NCT04466176 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2020-07-01 PHASE1
NCT04124094 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2019-10-01 PHASE1
NCT03535870 COMPLETED
Asthma
West-Ward Pharmaceutical
 2018-04-26
NCT03975166 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2019-05-21 PHASE1
NCT03894280 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2019-03-12 PHASE1
NCT03820180 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2019-01-23 PHASE1
NCT04195867 COMPLETED
Healthy Volunteers
Parc de Salut Mar
 2018-11-20 PHASE1
NCT03751202 COMPLETED
Bioequivalence
Respirent Pharmaceuticals Co Ltd.
 2018-11-20 PHASE1
NCT02554786 COMPLETED
Asthma
Novartis Pharmaceuticals
 2015-12-29 PHASE3
NCT03461627 UNKNOWN
Asthma
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2017-04-01 PHASE3
NCT03005717 COMPLETED
Submental Fat
Neothetics, Inc
 2016-12-22 PHASE2
NCT02113436 COMPLETED
Asthma
GlaxoSmithKline
 2014-05-01 PHASE4
NCT02649478 COMPLETED
Asthma
Roxane Laboratories
 2014-08
NCT02245672 COMPLETED
Asthma
Mylan Pharma UK Ltd.
 2014-10 PHASE3
NCT02218762 WITHDRAWN
Asthma
GlaxoSmithKline
 2014-10 PHASE1
NCT02260492 COMPLETED
Asthma
Oriel Therapeutics
 2014-09 PHASE1
NCT01890863 COMPLETED
Asthma
GlaxoSmithKline
 2013-08-05 PHASE1
NCT01636076 COMPLETED
COPD
Novartis Pharmaceuticals
 2012-11 PHASE2
NCT01795664 COMPLETED
Asthma
FLUIDDA nv
 2013-03 PHASE3
NCT00975195 COMPLETED
Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
 2009-02 PHASE4
NCT01802723 COMPLETED
Periumbilical Subcutaneous Adipose Tissue Reduction
Neothetics, Inc
 2013-02 PHASE2
NCT01772368 COMPLETED
Asthma
Teva Branded Pharmaceutical Products R&D, Inc.
 2013-01 PHASE2
NCT01712451 COMPLETED
Abdominal Contour Defects
Neothetics, Inc
 2011-08 PHASE2
NCT01321463 COMPLETED
Pulmonary Disease, Chronic Obstructive
Pfizer
 2011-05 PHASE2
NCT00565266 COMPLETED
Asthma
Milton S. Hershey Medical Center
 2008-05 PHASE3
NCT00497237 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2007-04 PHASE3
NCT00527826 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2007-11 PHASE4
NCT00127166 COMPLETED
Exercise Induced Asthma
Organon and Co
 2005-12 PHASE3
NCT00350207 COMPLETED
Asthma
Boehringer Ingelheim
 2006-07 PHASE2
NCT00556673 COMPLETED
Asthma
Novartis
 2007-10 PHASE2
NCT00448435 COMPLETED
Bronchial Asthma
GlaxoSmithKline
 2007-04 PHASE3
NCT00461500 COMPLETED
Asthma
GlaxoSmithKline
 2007-03 PHASE4
NCT01395849 Completed
Respiratory Disorders
GlaxoSmithKline
 2007-10 --
NCT00403286 COMPLETED
Chronic Obstructive Pulmonary Disease
Dey
 2006-11 PHASE2
NCT00102882 COMPLETED
Asthma
GlaxoSmithKline
 2004-10 PHASE4
NCT02242227 COMPLETED
Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
 2005-09 PHASE2
NCT00269126 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2005-02 PHASE3
NCT00273026 TERMINATED
Asthma
GlaxoSmithKline
 2004-11-08 PHASE4
NCT00394368 COMPLETED
Bronchial Asthma
Chiesi Farmaceutici S.p.A.
 2004-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Salmeterol Xinafoate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Salmeterol xinafoate selectively binds to and activates the beta-2 adrenergic receptor, triggering adenylate cyclase stimulation and elevated intracellular cyclic AMP levels that induce airway smooth muscle relaxation. This persistent bronchodilatory and anti-inflammatory response suppresses airway hyperresponsiveness and airflow obstruction, directly supporting its clinical application in conditions such as asthma and chronic obstructive pulmonary disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.