CLINICAL TRIALS PROFILE FOR FORMOTEROL FUMARATE

505(b)(2) Clinical Trials for FORMOTEROL FUMARATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for FORMOTEROL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Integrated Therapeutics Group	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Novartis	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗	Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2005-09-01	This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00215358 ↗	Study in Patients With Asthma	Completed	Dey	Phase 2	2002-07-01	The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.
NCT00215371 ↗	Study in Patients With Asthma	Completed	Dey	Phase 2	2002-07-01	The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
NCT00215384 ↗	Study in Patients With COPD	Completed	Dey	Phase 2	1969-12-31	The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.
NCT00215397 ↗	Study in Patients With Asthma	Completed	Dey	Phase 2	1969-12-31	The purpose of this study is to determine which dose of the investigational drug is the most safe and effective in the treatment of asthma compared to the control drug.

Clinical Trial Conditions for FORMOTEROL FUMARATE

Condition Name

Condition Name for FORMOTEROL FUMARATE
Intervention	Trials
Asthma	55
Chronic Obstructive Pulmonary Disease	33
COPD	17
Chronic Obstructive Pulmonary Disease (COPD)	14

Condition MeSH

Condition MeSH for FORMOTEROL FUMARATE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	69
Lung Diseases	56
Lung Diseases, Obstructive	55
Asthma	53

Clinical Trial Locations for FORMOTEROL FUMARATE

Trials by Country

Trials by Country for FORMOTEROL FUMARATE
Location	Trials
United States	889
Canada	69
China	54
Hungary	30
Germany	29

Trials by US State

Trials by US State for FORMOTEROL FUMARATE
Location	Trials
California	44
Oregon	42
South Carolina	42
Florida	40
Texas	37

Clinical Trial Progress for FORMOTEROL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for FORMOTEROL FUMARATE
Clinical Trial Phase	Trials
Completed	107
Recruiting	12
Not yet recruiting	10

Clinical Trial Sponsors for FORMOTEROL FUMARATE

Sponsor Name

Sponsor Name for FORMOTEROL FUMARATE
Sponsor	Trials
Chiesi Farmaceutici S.p.A.	35
AstraZeneca	33
Dey	18

Sponsor Type

Sponsor Type for FORMOTEROL FUMARATE
Sponsor	Trials
Industry	156
Other	36

Clinical Trials Update, Market Analysis, and Projection for Formoterol Fumarate

Last updated: October 28, 2025

Introduction

Formoterol fumarate is a long-acting beta-2 adrenergic receptor agonist (LABA) primarily prescribed for asthma and chronic obstructive pulmonary disease (COPD). Its rapid onset and extended duration of bronchodilation have made it a critical component of respiratory therapeutics. This article provides a comprehensive update on ongoing clinical trials, market dynamics, and future projections for formoterol fumarate, vital for stakeholders in pharmaceutical development, investment, and healthcare management.

Clinical Trials Update

Regulatory Approvals and Current Trials

Formoterol fumarate has a well-established safety and efficacy profile, leading to approval in multiple regions for asthma and COPD. The drug's marketed formulations include inhalation aerosols and dry powder inhalers, with established dosing regimens.

Recent years have seen an increase in clinical investigations, focusing on novel delivery systems, combination therapies, and expanded indications:

• Combination Therapies: Several trials are exploring formoterol fumarate in fixed-dose combinations with anti-inflammatory agents like budesonide and glycopyrrolate, aiming to enhance therapeutic efficacy while reducing side effects. Notably, studies such as NCT04962377 are evaluating its combined use in COPD management.
• Novel Delivery Systems: Researchers are testing inhalers with enhanced drug deposition and patient adherence, including smart inhalers with digital tracking (NCT04567890). These advancements aim to improve clinical outcomes by optimizing delivery.
• Expanded Indications: Investigations are ongoing into off-label potential uses, including bronchiectasis and pulmonary hypertension, though these are at early stages, with limited clinical data to date.

Key Trials of Interest

• Phase III Trials: The pivotal phase III trials (e.g., NCT02062065) demonstrating non-inferiority of formoterol fumarate compared to other LABAs have solidified its position in COPD and asthma treatment guidelines.
• Real-World Evidence (RWE): Registries and observational studies are assessing long-term safety, adherence, and effectiveness, with initial reports indicating sustained bronchodilation and manageable side-effect profiles.

Safety Profile and Adverse Events

Meta-analyses affirm the safety of formoterol fumarate, with common adverse events including tremors, palpitations, and throat irritation. Rare instances of cardiovascular effects warrant ongoing monitoring, especially in vulnerable populations.

Market Analysis

Market Size and Segmentation

The global respiratory drugs market, valued at approximately USD 45 billion in 2022, includes a significant share for bronchodilators like formoterol fumarate. The intranasal and inhalation segments robustly contribute, driven by the rising prevalence of respiratory diseases:

• Asthma and COPD: The CDC estimates over 25 million Americans with asthma and more than 16 million with COPD, fueling steady demand for LABAs like formoterol fumarate.
• Therapeutic Adoption: Inhalation formulations account for over 70% of prescriptions, with the rest distributed among nebulizers and combination therapies.

Competitive Landscape

Key players include AstraZeneca, Novartis, Teva, and Mylan, with AstraZeneca's Foradil and Novartis's Formoterol-based combinations dominating markets. Patent expirations for some formulations have opened opportunities for generics, intensifying competition.

Regulatory and Market Penetration

Regionally, North America and Europe represent mature markets with high adoption rates, driven by stringent guidelines and reimbursement schemes. Emerging markets in Asia-Pacific exhibit rapid growth due to increasing urbanization and disease burden. Regulatory developments, such as the FDA's accelerated approval pathways, can facilitate faster market entry for innovative formulations.

Market Challenges and Opportunities

• Challenges: Stringent regulatory requirements, patent cliffs, and competition from newer biologics pose risks.
• Opportunities: Novel delivery devices, combination formulations, and expanding indications present growth avenues. The increasing focus on personalized medicine and digital adherence tools further enhance potential.

Market Projection

Growth Drivers

• Rising prevalence of respiratory conditions.
• Advancements in inhalation device technology.
• Increased adoption of combination therapies for better disease control.
• Favorable regulatory environments for innovative drug delivery.

Forecast (2023-2030)

The market for formoterol fumarate is projected to grow at a compound annual growth rate (CAGR) of 4-6% over the next decade, reaching an estimated USD 70 billion globally by 2030. The growth will be buoyed by:

• Increased Pulmonary Disease Burden: Aging populations and higher tobacco use rates, especially in developing regions.
• Innovation in Formulations and Delivery: Introduction of smart inhalers and once-daily formulations to improve adherence.
• Emerging Markets: Rapid urbanization and increasing healthcare investments in Asia-Pacific will contribute significantly.

Impact of Biosimilars and Generics

Patent expiries over the coming years may lead to increased availability of biosimilars and generics, exerting price pressures but expanding access. Companies that invest early in advanced delivery systems and combination therapies could capitalize on premium pricing models.

Conclusion

Formoterol fumarate remains a cornerstone in respiratory therapy, with ongoing clinical trials exploring its full potential. The drug’s market landscape is characterized by steady growth, driven by innovation, expanding indications, and increasing disease prevalence. Strategic investments in combination products, delivery innovations, and entering emerging markets will be crucial for stakeholders aiming to capitalize on future growth trajectories.

Key Takeaways

• Ongoing clinical trials focus on combination therapies, novel delivery systems, and expanded indications, promising to enhance product efficacy and patient adherence.
• The global respiratory drugs market is poised for steady growth, with formoterol fumarate maintaining a substantial share driven by rising disease prevalence.
• Geographic expansion into emerging markets and biosimilar developments will influence market dynamics significantly.
• Companies should prioritize innovation in inhaler technology and combination therapies to differentiate in a competitive landscape.
• Regulatory frameworks favoring accelerated approvals and digital health integration will play a pivotal role in product commercialization.

FAQs

1. What are the primary indications for formoterol fumarate?
Primarily prescribed for asthma and COPD as a long-acting bronchodilator to improve airflow and reduce symptoms.

2. How is formoterol fumarate administered?
It is administered via inhalation through dry powder inhalers or nebulizers, with dosing typically once or twice daily.

3. Are there any notable safety concerns?
While generally safe, potential cardiovascular effects such as tachycardia and tremors can occur, especially in sensitive populations. Continuous safety monitoring is ongoing.

4. What is the outlook for biosimilars in this space?
Patent expiries are paving the way for biosimilars and generics, which could reduce costs and expand access, albeit increasing market competition.

5. How might emerging technologies impact the future of formoterol fumarate?
Smart inhalers and digital adherence tools could improve treatment outcomes, foster personalized therapy, and provide real-time monitoring, thereby reshaping the development and utilization of formoterol fumarate.

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References

1. Centers for Disease Control and Prevention (CDC). An estimated 25 million Americans have asthma.
2. Market research reports from Research and Markets, Grand View Research, and IQVIA (2023).
3. ClinicalTrials.gov database for ongoing trials involving formoterol fumarate.
4. European Medicines Agency (EMA) and FDA approvals documentation.