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formoterol (formoterol, Meda / Formatris Novolizer)

✓ Approved

Meda Co., Ltd. · ADRB2 · Small Molecule

What is formoterol?

formoterol is a small molecule developed by Meda Co., Ltd.. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand Namesformoterol, Meda, Formatris Novolizer
CompanyMeda Co., Ltd.
Drug ClassSmall Molecule
Molecular TargetADRB2
RouteInhaled
StatusApproved

Mechanism of Action

Molecular Targets

formoterol acts on 1 molecular target:

ADRB2adrenoceptor beta 2 (B2AR, ARB2)
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Therapeutic Indications

formoterol is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Respiratory, thoracic and mediastinal disordersChronic obstructive pulmonary disease✓ Approved

Related Research Articles

PubMedJournal of thoracic disease2026-10-13

Symptoms improvement and lung function benefits of fixed triple therapy with beclomethasone/formoterol/glycopyrronium inhalation powder in patients with moderate-to-severe COPD: outcomes of the Bulgarian arm of the RESPONSE study.

Petkov Rosen E RE, Kenderov Andrey N AN, Rodopska Neli L NL, Mekov Evgeni V EV et al.

The fixed triple beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/GB) therapy is available in both pressurized metered-dose inhaler (pMDI) and dry powder inhaler (DPI) formulations for chronic obstructive pulmonary disease (COPD) treatment. While the pMDI form has been extensively investigated in pivotal trials and real-world studies, real-world data on the DPI (88/5/9 μg) formulation remain limited. The RESPONSE study assessed the real-world effectiveness of BDP/FF/GB inhalation powder in a cohort of moderate-to-severe COPD patients uncontrolled with dual combinations. This non-interventional, prospective, multicenter study was conducted across 21 Bulgarian sites. COPD patients (≥35 years) with persistent symptoms [COPD Assessment Tool (CAT) ≥10 and/or modified Medical Research Council (mMRC) ≥2] and moderate or severe pulmonary obstruction [30%≤ forced expiratory volume in 1 second as a percentage of predicted value (FEV1%) <80%] despite dual therapies were switched to BDP/FF/GB DPI and followed for 6 months. The primary endpoint was improvement in CAT scores. Secondary endpoints included lung function, treatment adherence, dyspnea and the percentage of patients achieving CAT score reduction ≥2 from baseline. A total of 363 patients completed the study. Mean CAT scores improved significantly from 23.0 at baseline to 16.9 (P<0.001), regardless of prior dual therapy or inhaler type. Mean (± SD) FEV1% increased from 47.6%±11.9% to 53.2%±15.75% (P<0.001). Treatment adherence and dyspnea also showed significant improvement. Notably, 87.9% of participants achieved a CAT score reduction ≥2 points. The RESPONSE study showed that switching to BDP/FF/GB DPI was associated with clinically meaningful improvements in symptoms, lung function, and adherence in COPD patients inadequately controlled on dual therapy, supporting its role as a practical escalation option in routine care.

PubMedAmerican journal of respiratory and critical care medicine2026-10-08

2026 Global Initiative for Asthma (GINA) Strategy Report: Executive Summary and Key Changes.

Reddel Helen K HK, Allan Keith K, Bacharier Leonard B LB, Bonini Matteo M et al.

The Global Initiative for Asthma (GINA) Strategy Report provides a comprehensive, annually updated evidence-based approach to asthma diagnosis, assessment, treatment, and prevention across the lifespan. Its central approach is personalized, iterative care based on the Assess-Adjust-Review cycle for both symptom control and reduction of future risk (including severe exacerbations, persistent airflow limitation, and treatment-related harm). GINA emphasizes objective confirmation of diagnosis wherever possible, and regular assessment of lung function, inhaler technique, adherence, multimorbidity, risk factors (including Type-2 biomarkers), and patient goals and preferences. GINA strongly recommends that all adults, adolescents, children and most preschoolers with asthma should receive inhaled corticosteroid (ICS)-containing treatment. GINA recommends against short-acting beta2-agonist (SABA)-only treatment. For adults/adolescents, GINA Track 1 using low-dose ICS-formoterol, an anti-inflammatory reliever (AIR), either as-needed-only (AIR-only) or as maintenance-and-reliever therapy (MART), is preferred because of its substantial reduction in severe exacerbations compared with SABA-based regimens, and its simplicity. Age-specific treatment pathways in children also emphasize ICS-containing therapy and exacerbation prevention. For difficult-to-treat and severe asthma, GINA provides structured guidance, emphasizing diagnostic verification, optimization of modifiable factors, inflammatory phenotyping, biologic therapy selection, and (as for all patients) systemic corticosteroid stewardship. Acute exacerbation care incorporates long-term preventive treatment, including post-discharge reassessment of management and action plan. Key 2026 updates include expanded AIR options for adults and children, revised guidance on severe asthma and selection of biologic treatment, and substantial updates to acute asthma management. GINA integrates evidence-based management with shared decision-making, self-management education, implementation, and global advocacy to reduce preventable asthma morbidity and mortality.

PubMedRespiratory medicine2026-10-05

Early versus late escalation to extrafine BDP/FF/GB single-inhaler triple therapy in COPD: a real-world subgroup analysis by disease duration since diagnosis.

Rogliani Paola P, Brusselle Guy G, Stolz Daiana D, Piraino Alessio A et al.

The optimal timing for escalation to triple therapy in chronic obstructive pulmonary disease (COPD) remains undefined, often resulting in delayed treatment. Consequently, evidence on the effectiveness of early initiation is limited. This subgroup analysis used pooled patient-level data from six observational studies to evaluate the real-world effectiveness of beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide single-inhaler triple therapy (SITT) in COPD according to disease duration. Patients were stratified into three subgroups: ≤48 months (short), 49-96 months (intermediate), and ≥97 months (long-standing). Outcomes assessed at 3, 6, and 12 months post-SITT initiation included mean number of exacerbations, proportion of patients experiencing ≥1 exacerbation, and proportion achieving disease stability and control. Mean number of exacerbations decreased from the year prior to SITT initiation at all post-treatment time points across all subgroups, with the largest reductions observed in short disease patients, particularly at 12 months. Similarly, the proportion of patients experiencing ≥1 exacerbation decreased in all subgroups, with the lowest proportions observed in short disease patients. No differences between subgroups were observed at 3 and 6 months in the proportion of patients achieving disease stability and control; conversely, at 12 months the short disease subgroup showed significantly higher rates of disease stability and control compared with longer disease duration subgroups, suggesting that earlier SITT initiation may provide more sustained benefits. Early escalation to SITT in COPD may result in more durable sustained clinical benefits compared with later intervention, reducing exacerbations and maintaining disease stability and control up to 12 months.

PubMedERJ open research2026-09-29

Airway inflammation and asthma control in patients using salbutamol or budesonide/formoterol reliever: a randomised, controlled study.

Martin Matthew J MJ, Pavord Ian D ID, Chalmers James D JD, Saralaya Dinesh D et al.

Maintenance and reliever therapy (MART) with budesonide/formoterol (BUD/FORM) may offer asthma control with a single inhaler. This 6-month exploratory study monitored asthma symptoms, reliever use, lung function, airway inflammation and exacerbation events to determine treatment effectiveness in patients receiving BUD/FORM MART or BUD/FORM maintenance therapy plus short-acting β2-agonist (SABA). In the open-label STIFLE study (NCT03924635), patients were randomised to BUD/FORM MART (100 μg/6 μg or 200 μg/6 μg per inhalation, pro re nata (PRN)) or the same dose of BUD/FORM BID as maintenance therapy plus SABA (salbutamol) reliever PRN (100 μg per inhalation). Data were captured at home each day using devices connected to a smartphone via the STIFLE application. Occurrence of pre-defined exacerbation events required patients to attend hospital for assessment. 42 patients were randomised. Adherence to daily measurements exceeded 80% in both treatment groups. The proportion of patients experiencing an exacerbation was 27.8% in the BUD/FORM MART versus 70.8% in the BUD/FORM maintenance plus SABA group. A similar trend was observed in patients who experienced ≥1 day with ≥6 reliever uses (3 (16.7%) versus 9 (37.5%) patients, respectively). Patients treated with BUD/FORM MART showed less variation in airway inflammation, asthma symptom scores, lung function parameters and reliever use, versus BUD/FORM maintenance therapy plus SABA. No unexpected safety findings were observed. Patients with moderate asthma treated with BUD/FORM MART recorded less variation in asthma outcomes and lower rates of exacerbation events than those treated with BUD/FORM maintenance therapy plus SABA, suggesting improved asthma control.

PubMedThe Journal of international medical research2026-09-28

Recurrent multiterritorial ischemic stroke with persistent moderate hypereosinophilia: A case report with focused literature review.

Wang Yu Y, Liu Na N, Zhu Ju J

Persistent hypereosinophilia may be overlooked during stroke evaluation when conventional vascular risks coexist. We report the case of a man in his late 50s who had hypertension, type 2 diabetes, continued active smoking, and eight clinically apparent magnetic resonance imaging-confirmed strokes in multiple bilateral territories over 29 months. Before systemic glucocorticoid exposure, absolute eosinophil counts ranged from 1.87 to 3.23 × 109/L on repeated measurements. Bone marrow morphology and flow cytometry revealed eosinophil expansion without aberrancy, and common tested clonal drivers were negative. Transthoracic echocardiography, two 24-h Holter recordings, and a bubble study identified no intracardiac source. Aortic computed tomography angiography in April 2026 demonstrated thoracic aortic atherosclerosis with calcified plaques and focal ulceration; transesophageal echocardiography and prolonged rhythm monitoring were not performed. A new left pontine infarct occurred in April 2026 while he was on oral prednisone (20 mg/day). In August 2026, after systemic glucocorticoid withdrawal despite continued inhaled budesonide/formoterol, a new right temporal infarct occurred, with an absolute eosinophil count of 2.66 × 109/L. Worsening wheeze suggested possible eosinophilic airway inflammation; however, emphysema alone did not explain systemic eosinophilia, and eosinophilic granulomatosis with polyangiitis remained unproven. The available evidence favored a multifactorial interpretation; eosinophilia provides biological plausibility, whereas conventional vascular risks and an incompletely characterized thoracic aortic abnormality remain competing explanations. Persistent eosinophilia should prompt repeated etiological reassessment without inferring causality based on blood count or imaging pattern alone.

PubMedPragmatic and observational research2026-09-23

Evaluating Satisfaction and Quality of Life with Elpenhaler: A Pooled Analysis of Real-Life Studies.

Gogali Athena A, Ginis Alexandros A, Bertoli Maria M, Papanastasiou Polyanthi P et al.

Patient adherence and satisfaction are critical for effective asthma and chronic obstructive pulmonary disease (COPD) management, as adherence strongly influences symptoms and prognosis. Patient-reported outcomes, including treatment satisfaction and quality of life, provide valuable insights into the effectiveness of therapeutic interventions from the perspective of individual patients. This study evaluated patient satisfaction with the Elpenhaler device and its impact on quality of life in routine clinical practice. Individual participant data were pooled from seven real-life studies of fixed-dose combinations delivered via the Elpenhaler device (asthma, budesonide/formoterol: BOREAS, SKIRON, COMPLETE, NOTOS; COPD, salmeterol/fluticasone: AEOLOS, AHEAD, RETRIEVE). Patient satisfaction was assessed with the Feeling of Satisfaction with Inhaler (FSI-10) questionnaire in the four studies in which it was administered, and quality of life in asthma with the mini Asthma Quality of Life Questionnaire (mAQLQ) at baseline, 3 and 6 months. The minimum clinically important difference (MCID) was defined as a change of at least 0.5 units in the mAQLQ total score. In 4333 patients with evaluable FSI-10 score, overall satisfaction was high (mean total score 44.1, standard deviation 5.4), with 94.5% of patients expressing confidence in correct usage. Multivariable analysis showed that age ≥65 years, male sex and lower education level were independently associated with lower satisfaction, whereas never smoking predicted higher satisfaction. In 4212 patients with asthma, mAQLQ total score improved from 4.52 at baseline to 6.06 at 3 months and 6.27 at 6 months; the MCID was achieved by 83.4% and 87.8% of evaluable patients, respectively. Never smoking and lower education level predicted MCID achievement. Treatment delivered via the Elpenhaler is associated with high patient satisfaction and with significant and sustained improvements in quality of life, supporting its effectiveness in real-world respiratory care. The identification of factors associated with satisfaction and quality of life improvement may help in personalising treatment and optimising care.

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