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formoterol (formoterol, Meda / Formatris Novolizer)

✓ Approved

Meda Co., Ltd. · ADRB2 · 小分子

什么是 formoterol？

formoterol 是一种小分子，由Meda Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Inhaled。

药物档案

商品名formoterol, Meda, Formatris Novolizer
公司Meda Co., Ltd.
药物类别小分子
分子靶点ADRB2
给药途径Inhaled
状态Approved
来源： ClinicalTrials.gov, Meda Co., Ltd.

作用机制

分子靶点

formoterol 作用于 1 个分子靶点：

ADRB2adrenoceptor beta 2 (B2AR, ARB2)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

formoterol 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Respiratory, thoracic and mediastinal disordersChronic obstructive pulmonary disease✓ Approved

相关研究文献

PubMedAdvances in respiratory medicine2026-10-26

Deciphering the Benefits and Risks of Single-Inhaler Triple Therapy in COPD.

Kopitovic Ivan I, Dimic-Janjic Sanja S, Stjepanovic Mihailo M, Hromis Sanja S et al.

Single-inhaler triple therapy (SITT) combines an inhaled corticosteroid (ICS; for example, fluticasone furoate, budesonide, or beclometasone dipropionate), a long-acting β2-agonist (LABA; for example, vilanterol or formoterol fumarate), and a long-acting muscarinic antagonist (LAMA; for example, umeclidinium or glycopyrronium bromide) in one device. Triple pharmacological therapy reduces exacerbations in selected patients with chronic obstructive pulmonary disease (COPD), but its effects on mortality and cardiovascular outcomes remain uncertain. This structured narrative review summarizes randomized trials, observational comparative-effectiveness studies, target trial emulations, systematic reviews, and health technology assessments published between 2015 and 2026. We grouped the evidence by comparator: LABA/LAMA, ICS/LABA, multiple-inhaler triple therapy (MITT), and ICS continuation versus withdrawal, because each comparison addresses a different clinical question. Pivotal trials and evidence syntheses consistently showed fewer moderate-to-severe exacerbations with triple therapy, with reported rate ratios of approximately 0.69-0.93. Mortality signals from IMPACT and ETHOS are clinically important, but previous ICS use and ICS withdrawal among participants assigned to ICS-free comparators make these findings difficult to interpret. Observational cardiovascular findings are also uncertain because residual confounding, treatment selection, exposure misclassification, outcome misclassification, and differences in baseline disease severity limit causal interpretation. Compared with MITT, the main advantages of SITT are simpler treatment and possible improvements in adherence and persistence, not greater pharmacological potency. Treatment decisions should consider exacerbation history, repeated blood eosinophil counts, pneumonia risk, cardiovascular disease, previous ICS exposure and response, inhaler technique, device suitability, and patient preference. Trials in patients with documented absence of previous ICS use and well-designed target trial emulations are needed to determine whether the observed mortality and cardiovascular associations are causal.

PMID 42930048
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PubMedMikrochimica acta2026-10-25

Ag-decorated sulfur-rich covalent organic framework for SERS fingerprinting of β2-adrenergic agonists olodaterol, indacaterol, and formoterol.

Li Min M, Yang Fang F, Huang Qingyu Q, Luo Xiaojun X

Olodaterol, indacaterol, and formoterol are the most frequently abused β2-agonists. The World Anti-Doping Agency (WADA) has imposed a threshold limit of 40 ng/mL for formoterol in urine and a total ban on olodaterol and indacaterol. Therefore, it is urgent to develop sensitive analytical methods for the identification and quantification of the three compounds. Herein, for the first time, we fabricated a sulfur rich covalent organic framework supported silver-nanoparticle (Ag-SCOF) substrate for surface enhanced Raman spectroscopy (SERS). Benefiting from the strong Ag-S covalent bonds, silver nanoparticles can be firmly anchored on the SCOF matrix to effectively suppress nanoparticle aggregation and improve substrate stability. Target β2-agonists can be enriched into electromagnetic hot spots via Ag-N interactions, thereby greatly amplifying Raman signals. The analytical enhancement factor of this substrate reaches 3.89 × 105. The limits of detection (LODs) for olodaterol, indacaterol, and formoterol reach 8.61 × 10⁻8, 8.03 × 10⁻8, and 9.63 × 10⁻8 g·mL⁻1, respectively. This Ag-SCOF SERS platform achieves rapid (within 3 min), fingerprint-based simultaneous detection, overcoming the drawbacks of conventional methods such as high cost, long assay time and low specificity. The proposed method fully meets the detection requirements of WADA regulations and food safety monitoring, and has great potential for on-site analysis of real samples.

PMID 42925429
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PubMedAdvances in therapy2026-10-22

Impact of Budesonide/Glycopyrronium/Formoterol Initiation on Healthcare Resource Utilization and Estimated Associated Costs and Greenhouse Gas Emissions Across COPD Care in Spain (ORESTES* Study).

Figueira-Gonçalves Juan Marco JM, Alcázar-Navarrete Bernardino B, Ancochea Alba A, Lastres Teresa T et al.

Chronic obstructive pulmonary disease (COPD) is associated with substantial healthcare resource utilization (HCRU), high healthcare costs, and a considerable environmental burden. Triple therapy, such as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF), is recommended for patients with COPD not adequately controlled by dual therapy. Real-world assessments of the economic and environmental implications of COPD treatment strategies remain limited. This study estimated the impact of BGF initiation on HCRU-related costs and greenhouse gas (GHG) emissions in Spain. This post hoc analysis used data from the multicenter, observational, retrospective ORESTES study. Adult patients with COPD who had initiated BGF and had at least 12 months of clinical data before treatment initiation were included. HCRU and actual use of short-acting β-2 agonists (SABA) were assessed before and after BGF initiation, and associated costs and GHG emissions were estimated using unit costs and emission factors from the perspective of the Spanish National Health System. A total of 718 patients were included. Following BGF initiation, annualized rates of hospitalizations, hospitalized days, emergency room admissions, primary care visits, and actual SABA use decreased by 12.9%, 9.2%, 12.0%, 4.9%, and 25.5%, respectively. Estimated annual HCRU-related costs decreased by €200.11 per patient, from €2599.46 before BGF initiation to €2399.35 after initiation, mainly driven by reduced hospitalization costs. Estimated annual HCRU-related GHG emissions decreased by 25.16 kg CO2e per patient, from 245.43 to 220.27 kg CO2e, primarily because of reductions in hospitalizations and actual SABA use. This post hoc analysis estimated reductions in HCRU-related costs and GHG emissions following BGF initiation in patients with COPD in routine clinical practice in Spain. These findings suggest that the clinical and HCRU improvements observed after BGF initiation may translate into meaningful HCRU-related economic and environmental benefits at the healthcare system level, reinforcing the broader value of clinically appropriate COPD treatment optimization. NCT06321731.

PMID 42907700
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PubMedThe Journal of asthma : official journal of the Association for the Care of Asthma2026-10-18

A Prospective Observational Real-World Study to Assess the Effectiveness and Safety of Single-Inhaler Triple Therapy with Glycopyrrolate/Formoterol Fumarate/Budesonide in Patients with Uncontrolled Asthma.

Thekkinkattil Mohankumar M, Katiyar Subodh S, Gopal Bharat B, Saha Arnab A et al.

Individuals with asthma remain inadequately controlled despite treatment with inhaled corticosteroid and long-acting β2-agonist (ICS/LABA) therapy. Single-inhaler triple therapy (SITT) combining ICS, LABA, and long-acting muscarinic antagonist (LAMA) offers a practical treatment escalation option. This study aims to assess the real-world effectiveness, safety, and adherence of SITT with budesonide/glycopyrrolate/formoterol fumarate in adults with uncontrolled asthma. This multicentric, prospective, observational study was conducted across five centers in India. Adults with uncontrolled asthma on stable ICS/LABA therapy who were prescribed SITT as part of routine care were followed for 12 weeks. Changes in lung function, asthma control (ACT), and quality of life (Mini-AQLQ) were assessed. Medication adherence, adverse events, and asthma exacerbations were recorded. Of 258 enrolled patients, 231 were included in the final analysis. Spirometry measurements showed notable improvements before and after bronchodilator use (all p < 0.001). These included higher MMEF values, suggesting improved small-airway function. Mean ACT scores improved from 14.29 at baseline to 18.49 at follow-up. Mini-AQLQ scores also improved over 12 weeks, indicating better patient-reported quality of life. Medication adherence was high, and no asthma exacerbations, adverse events, or serious adverse events were reported during follow-up. In routine practice, SITT BGF was associated with short-term improvements in lung function, asthma control, and QoL in adults with uncontrolled asthma. The mean ACT improved to partially controlled range at 12 weeks. Results suggest short-term effectiveness and tolerability, but longer-term and comparative studies are needed.

PMID 42892309
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PubMedJournal of chromatographic science2026-10-18

Glycopyrronium bromide, formoterol fumarate dihydrate and their related compounds with UPLC/PDA-MS for simultaneous determination in pressurized metered-dose inhaler product.

Seckin Serdar S, Aslan Serap Saglik SS

An ultra-performance liquid chromatography (UPLC) technique with photodiode array-mass spectrometry (PDA-MS) detectors has been developed and validated for the determination of glycopyrronium bromide (GB), formoterol fumarate dihydrate (FFD) and their related substances in pressurized meter dose inhalers. This marks the first time the method has been implemented. Chromatographic analyses have been carried out on a UPLC system with a single quadrupole mass spectrometer (QDa) and a PDA detector. A C18 column has been used prior to the injection valve. The column temperature was set to 40°C. For each analysis, 1 μL of sample was injected at a flow rate of 0.1 mL/minute. The mobile phases used were A (0.5% formic acid in methanol) and B (0.5% formic acid in water). The total run time of the method was 30 minutes. The PDA detector was employed at 215 nm while the mass detector was set to extracted ion chromatography (XIC) mode. The range for detecting impurities of GB was found to be between 0.28 and 0.30 ng/mL, with a limits of 0.92-1.01 ng/mL for quantification. GB and FFD demonstrated linear accuracy. We studied the accuracy of related substances within the limit of quantification value range of corresponding impurities and up to 400% of the limit value. The method we used was linear, rapid, reproducible and accurate. Our proposed method is fast, linear, accurate and reproducible. The UPLC-MS method, which utilized QDa with XIC mode, was developed to ascertain the related substances and assay of GB and FFD.

PMID 42893550
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PubMedRespiratory medicine2026-10-16

Efficacy and safety of novel nebulized combination of glycopyrronium, formoterol and budesonide in comparison with metered dose inhaler of glycopyrronium, formoterol and budesonide in COPD - A randomized, double-blind, double-dummy clinical trial.

Kodgule Rahul R, Jagdale Sunil S, Wu Wen W, Nikalje Rajkumar R et al.

Many patients with chronic obstructive pulmonary disease (COPD) are unable to use metered dose inhaler (MDI) or dry powder inhaler effectively and require treatment with nebulized medication. No triple combination is available in nebulized form. In this randomized, double-blind study, 314 patients with COPD received either Glycopyrronium 25 μg/Formoterol Fumarate 20 μg/Budesonide 500 μg (GB/FF/BUD Neb) by nebulization twice daily or Glycopyrronium 7.2 μg, Formoterol Fumarate 5 μg, Budesonide 160 μg MDI (GB/FF/BUD MDI) 2 Puffs twice daily for 12 weeks. The primary endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV1) at week 12. At week 12, GB/FF/BUD Neb was non-inferior (NI) to GB/FF/BUD MDI in change from baseline in trough FEV1 [LS mean (SE) difference -0.00 L (95% CI, -0.04 to 0.04); p < 0.001 for NI with NI margin -0.08 L). At week 12, the between group difference was 0.04 L (95% CI: -0.00 to 0.09; p = 0.070) in 2-h post-dose FEV1 and -0.24 (95% CI: -0.42 to -0.07; p = 0.007) in the modified Medical Research Council (mMRC) dyspnoea score. There was no difference between treatments in the rescue medication use and change from baseline in trough forced vital capacity. No serious adverse event or death was reported. Overall, adverse events were comparable between the two groups. GB/FF/BUD Neb was non-inferior to GB/FF/BUD MDI in improving lung function evaluated by trough FEV1 in patients with COPD. GB/FF/BUD Neb was found to be safe and well tolerated. CTRI/2024/10/075606 (Clinical Trial Registry - India).

PMID 42887614
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