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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
Sources: ClinicalTrials.gov, Meda Co., Ltd.

Mechanism of Action

Molecular Targets

formoterol acts on 1 molecular target:

ADRB2adrenoceptor beta 2 (B2AR, ARB2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

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

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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PubMedInternational immunopharmacology2026-10-16

Ensifentrine inhibits lipopolysaccharide-induced production of cytokines by human lung macrophages: a comparison with roflumilast, and an interaction with adenosine.

Brollo M M, Salvator H H, Glorion M M, Marquant Q Q et al.

The dual phosphodiesterase (PDE) 3/4 inhibitor ensifentrine was recently approved for the maintenance treatment of chronic obstructive pulmonary disease in adults. Ensifentrine anti-inflammatory effects have not been studied in human lung macrophages (LMs), which are critically involved in respiratory disease. The main objectives of the present study were to compare the inhibitory effects of ensifentrine, the PDE4 inhibitor roflumilast, and the non-selective PDE inhibitor theophylline on the lipopolysaccharide (LPS)-induced production of cytokines by LMs and to assess interactions with the adenosine analogue 5´-N-ethyl-carboxamidoadenosine (NECA). LMs isolated from resected human lungs were incubated with a range of concentrations of ensifentrine, roflumilast, theophylline, NECA, and formoterol, and stimulated with LPS for 24 h. The levels of tumour necrosis factor-alpha (TNF-α), CCL2, CCL3, and CCL4 in the culture supernatants were measured using ELISAs. Ensifentrine reduced the LPS-stimulated production of TNF-α by LMs in a concentration-dependent manner, with a 100-fold lower potency but a 20-30% higher efficacy than roflumilast. Theophylline and formoterol were essentially inactive. The relative reductions in the LPS-induced production of TNF-α and the three CCL chemokines associated with treatment with the two selective inhibitors was further accentuated by NECA and resulted in similar levels of cytokine production inhibition (between 65% and 95%) with the two PDE inhibitors. Clinically relevant concentrations of ensifentrine and roflumilast partially inhibited the LPS-induced production of cytokines by LMs - cytokine production that might be enhanced during inflammatory flare-ups of respiratory diseases.

PMID 42887045
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PubMedInternational archives of allergy and immunology2026-10-15

Montelukast combined with ICS/LABA improves clinical outcomes in moderate-to-severe persistent asthma by modulating T lymphocyte subset-related cytokine profiles.

Cai Wanlong W, Cao Yinghua Y, Wang Li L, Zhou Shengli S et al.

Glucocorticoids and montelukast, an anti-leukotriene agent, target different inflammatory pathways. This study aims to investigate the immunological synergy of their combination. A prospective, randomized, controlled, open-label study was conducted. Two hundred and third-four patients were randomly assigned to two groups for a 12-week treatment period. Control group [ICS+long-acting beta₂-agonist (LABA)]; n = 118): Budesonide 400 µg/day (200 µg twice daily) + formoterol 18 µg/day (9 µg twice daily). Combination group (n = 116): Same ICS+LABA regimen + Montelukast 10 mg orally once daily. At Week 12, the ICS+LABA+Mon group demonstrated significantly greater improvements in pre-bronchodilator FEV₁ compared with the ICS+LABA group (mean change: +239.0 ± 70.5 mL vs. +141.2 ± 47.9 mL; between-group difference 97.8 mL; 95% CI: 82.4 to 113.2; P < 0.001). Asthma control improved more substantially with combination therapy, as shown by greater ACQ-6 score reductions, with the mean score in the combination group approaching the well-controlled threshold. Immunologically, combination therapy produced a significantly greater increase in IFN-γ and Treg cytokines IL-10 and TGF-β, alongside more pronounced suppression of T helper 2 (Th2) cytokines (IL-4, IL-5, and IL-13) and the Th17 cytokine IL-17. The addition of montelukast to ICS+LABA therapy significantly enhances pulmonary function, asthma control, and suppression of eosinophilic airway inflammation in moderate-to-severe persistent asthma via a favorable immunological shift characterized by enhanced Th1 and Treg responses and more potent suppression of Th2 and Th17 pathways.

PMID 42879358
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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.

PMID 42865803
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