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Formoterol/Fluticasone
Formoterol/Fluticasone is a Long-acting beta-2 agonist / Inhaled corticosteroid combination Small molecule drug developed by Eurofarma Laboratorios S.A.. It is currently in Phase 3 development for Asthma maintenance and reliever therapy, Chronic obstructive pulmonary disease (COPD).
Formoterol is a long-acting beta-2 agonist that relaxes airway smooth muscle, while fluticasone is a corticosteroid that reduces airway inflammation.
Formoterol is a long-acting beta-2 agonist that relaxes airway smooth muscle, while fluticasone is a corticosteroid that reduces airway inflammation. Used for Asthma maintenance and reliever therapy, Chronic obstructive pulmonary disease (COPD).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Formoterol/Fluticasone |
|---|---|
| Sponsor | Eurofarma Laboratorios S.A. |
| Drug class | Long-acting beta-2 agonist / Inhaled corticosteroid combination |
| Target | Beta-2 adrenergic receptor; Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
This combination inhaler works through dual action: formoterol stimulates beta-2 adrenergic receptors on bronchial smooth muscle to produce rapid and sustained bronchodilation, while fluticasone propionate binds to glucocorticoid receptors to suppress inflammatory mediators, reduce mucus production, and decrease airway hyperresponsiveness. Together, they provide both immediate symptom relief and long-term control of airway obstruction and inflammation.
Approved indications
- Asthma maintenance and reliever therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
- Muscle cramps
Key clinical trials
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- VENTURI (VENTilation Using Respiratory Imaging) (PHASE2)
- Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (PHASE4)
- Immuno-inflammatory Response of Erdosteine in COPD (NA)
- Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA) (PHASE3)
- Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil (PHASE3)
- Individualizing Treatment for Asthma in Primary Care (Full Study) (PHASE4)
- Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Formoterol/Fluticasone CI brief — competitive landscape report
- Formoterol/Fluticasone updates RSS · CI watch RSS
- Eurofarma Laboratorios S.A. portfolio CI
Frequently asked questions about Formoterol/Fluticasone
What is Formoterol/Fluticasone?
How does Formoterol/Fluticasone work?
What is Formoterol/Fluticasone used for?
Who makes Formoterol/Fluticasone?
What drug class is Formoterol/Fluticasone in?
What development phase is Formoterol/Fluticasone in?
What are the side effects of Formoterol/Fluticasone?
What does Formoterol/Fluticasone target?
Related
- Drug class: All Long-acting beta-2 agonist / Inhaled corticosteroid combination drugs
- Target: All drugs targeting Beta-2 adrenergic receptor; Glucocorticoid receptor
- Manufacturer: Eurofarma Laboratorios S.A. — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Asthma maintenance and reliever therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing