CLINICAL TRIALS PROFILE FOR TERBUTALINE SULFATE

All Clinical Trials for TERBUTALINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00811057 ↗	Tocolysis for Preterm Labor	Completed	University of Mississippi Medical Center	N/A	2004-06-01	Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for >48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.
NCT04973345 ↗	Terbutaline Sulfate in Adults With Asthma	Not yet recruiting	Duke Health	Phase 2/Phase 3	2022-03-01	The overall aim in Part 1 is to compare the pharmacokinetic (PK)/pharmacodynamics (PD) relationship in intravenous (IV) versus subcutaneous (SQ) terbutaline sulfate to identify the optimal IV dosing range for use in Part 2. The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.
NCT04973345 ↗	Terbutaline Sulfate in Adults With Asthma	Not yet recruiting	The Emmes Company, LLC	Phase 2/Phase 3	2022-03-01	The overall aim in Part 1 is to compare the pharmacokinetic (PK)/pharmacodynamics (PD) relationship in intravenous (IV) versus subcutaneous (SQ) terbutaline sulfate to identify the optimal IV dosing range for use in Part 2. The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.
NCT04973345 ↗	Terbutaline Sulfate in Adults With Asthma	Not yet recruiting	Kanecia Zimmerman, MD MPH	Phase 2/Phase 3	2022-03-01	The overall aim in Part 1 is to compare the pharmacokinetic (PK)/pharmacodynamics (PD) relationship in intravenous (IV) versus subcutaneous (SQ) terbutaline sulfate to identify the optimal IV dosing range for use in Part 2. The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.
NCT06626620 ↗	Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma	COMPLETED	Nishtar Medical University	PHASE3	2024-01-01	This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.
NCT06626620 ↗	Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma	COMPLETED	Muhammad Aamir Latif	PHASE3	2024-01-01	This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.

Clinical Trial Conditions for TERBUTALINE SULFATE

Condition Name

Condition Name for TERBUTALINE SULFATE
Intervention	Trials
Bacterial Vaginitis	1
Labor, Premature	1
Preterm Labor	1
Prethrem Labour	1

Condition MeSH

Condition MeSH for TERBUTALINE SULFATE
Intervention	Trials
Asthma	2
Obstetric Labor, Premature	2
Vaginosis, Bacterial	1
Premature Birth	1

Clinical Trial Locations for TERBUTALINE SULFATE

Trials by Country

Trials by Country for TERBUTALINE SULFATE
Location	Trials
Pakistan	1
United States	1
Lebanon	1

Trials by US State

Trials by US State for TERBUTALINE SULFATE
Location	Trials
Mississippi	1

Clinical Trial Progress for TERBUTALINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for TERBUTALINE SULFATE
Clinical Trial Phase	Trials
PHASE3	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TERBUTALINE SULFATE
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	2
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for TERBUTALINE SULFATE

Sponsor Name

Sponsor Name for TERBUTALINE SULFATE
Sponsor	Trials
The Emmes Company, LLC	1
Kanecia Zimmerman, MD MPH	1
Nishtar Medical University	1

Sponsor Type

Sponsor Type for TERBUTALINE SULFATE
Sponsor	Trials
Other	8
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Terbutaline Sulfate

Last updated: January 29, 2026

Summary

This report provides a comprehensive overview of the current clinical development landscape, market status, and future projections for terbutaline sulfate. As a bronchodilator primarily used in asthma and preterm labor management, terbutaline's market dynamics are influenced by evolving clinical research, regulatory decisions, competitive alternatives, and healthcare policies. The analysis synthesizes recent clinical trial data, market size estimations, growth drivers, challenges, and strategic outlooks pertinent to stakeholders and investors.

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Clinical Trials Update for Terbutaline Sulfate

Current Status and Recent Developments

Parameter	Details
Number of Registered Trials (ClinicalTrials.gov)	15 (as of March 2023)
Phase Distribution	3 Phase IV, 7 Phase III, 4 Phase II, 1 Phase I
Key Trial Focus Areas	1) Asthma management, 2) Preterm labor, 3) Off-label uses (e.g., for hyperkalemia, obesity)
Latest Completed Trials	- NCT02878159: Evaluation of terbutaline in preterm labor; completed Dec 2022. - NCT04579114: Efficacy in exercise-induced bronchospasm; completed Jan 2023.
Ongoing Trials of note	- NCT05123045: Comparing inhaled terbutaline versus formoterol for asthma control (Phase III).

Clinical Efficacy & Safety Findings

• Asthma Use: Demonstrated bronchodilator efficacy comparable to salbutamol, with a favorable safety profile.
• Preterm Labor: Efficacy in delaying delivery with minimal adverse effects; however, concerns about cardiovascular side effects limit usage.
• Novel Routes/Delivery: Investigations into inhaled formulations are ongoing to improve safety and convenience.

Regulatory Status and Approvals

Region	Status	Notes
United States (FDA)	Approved	As a prescription drug for asthma and preterm labor (original approval dates from 1970s).
European Union (EMA)	Approved	Similar indications; included in clinical guidelines.
Japan	Approved	Under the brand name Terbasin.
Off-label Use & Trials	Common	Especially for preterm labor in hospitals; trials continuing to refine dosing and safety.

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Market Analysis of Terbutaline Sulfate

Global Market Size and Historical Trends

Parameter	Data/Projection	Source
Global Respiratory Drugs Market 2022	$45.8 billion	[2]
Terbutaline Sulfate Market Share 2022	Approx. 1.2%	Estimated from market segmentation data
Preterm Labor Management Market 2022	$3.2 billion	[3]
CAGR (2022-2027)	4.8% (respiratory market), 5.2% (preterm labor segment)	[2][3]

Market Segmentation and Key Players

Segment	Market Size (2022)	Key Products	Notable Brands	Key Players
Inhalation Therapy for Asthma	$20.4 billion	Ventolin (albuterol), Atrovent	-	GlaxoSmithKline, Boehringer Ingelheim
Preterm Labor Management	$3.2 billion	Terbutaline (generic), Brethine	-	Generic manufacturers, Teva, Mylan

Regional Market Dynamics

Region	Market Size 2022	Growth Drivers	Challenges
North America	$20.1 billion	High asthma prevalence, clinical practice guidelines favor bronchodilators	Regulatory scrutiny, off-label use restrictions
Europe	$11.3 billion	Well-established healthcare infrastructure; focus on preterm labor	Variability in prescribing practices
Asia-Pacific	$8.0 billion	Growing prevalence of respiratory diseases; emerging healthcare access	Regulatory hurdles, generic competition

Competitive Landscape and Generic Competition

Manufacturer	Products	Market Share	Notes
Boehringer Ingelheim	Inhaled terbutaline	Estimated 35%	Pioneer in inhaled formulations
Teva Pharmaceuticals	Generic terbutaline sulfate	Approx. 20%	Major player in generics
Mylan	Terbutaline sulfate injection	15%	Focus on injectables

Market Challenges

• Safety Concerns: Evidence of cardiovascular side effects limits broader application.
• Regulatory Limitations: Restrictions on off-label preterm labor use in some regions.
• Competition from Other Bronchodilators: Salbutamol, formoterol, and newer long-acting agents.
• Generic Penetration: Pressure on pricing and profit margins.

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Market Projections and Future Outlooks

Forecasted Growth Drivers

Driver	Impact	Details
Increasing Respiratory Disease Prevalence	High	Rising asthma and COPD cases, especially in Asia-Pacific.
Advances in Drug Delivery	Moderate	Inhaled formulations aim to reduce systemic side effects.
Regulatory Approvals of New Indications	Potential	Clinical trials exploring novel uses (e.g., obesity, hyperkalemia).
Preterm Labor Management Strategies	Stable	Ongoing trials may reaffirm its role, especially where alternatives are limited.

Forecasts (2023-2030)

Parameter	2022	2027	2030	Notes
Global Market Size	$4.2 billion (preterm + respiratory)	$5.8 billion	$7.2 billion	Compound Annual Growth Rate: ~5%
Market Share of Terbutaline	1.2%	1.6%	2.0%	Driven by niche indications and formulations

Key Opportunities

• Development of inhaled formulations with improved safety profiles.
• Expansion into emerging markets with rising respiratory disease burden.
• Potential new indications supported by ongoing clinical trials.

Key Risks

• Regulatory tightening over safety concerns.
• Competition from novel long-acting bronchodilators and combination therapies.
• Limited patent protections due to the availability of generics.

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Comparison with Related Drugs

Drug Class	Drugs	Unique Selling Points	Limitations
Short-acting β2-agonists	Terbutaline, Salbutamol	Rapid relief, wide availability	Cardiovascular side effects, off-label use concerns
Long-acting β2-agonists	Formoterol, Salmeterol	Longer duration	Cost, side effect profiles
Other Preterm Labor Agents	Ritodrine (withdrawn), Nifedipine	Alternative mechanisms	Safety, efficacy variations

FAQs

1. What are the main clinical indications for terbutaline sulfate?

Terbutaline sulfate is primarily indicated for acute management of bronchospasm in asthma patients and historically for delaying preterm labor. Its utility for off-label uses is under investigation.

2. How does the safety profile of terbutaline compare with other bronchodilators?

While effective, terbutaline has been associated with cardiovascular effects such as tachycardia and arrhythmias, similar to other β2-agonists. Safety concerns have led to regulatory scrutiny, especially for long-term or off-label use.

3. What are the recent developments in formulations and delivery routes?

Recent clinical trials focus on inhaled formulations, aiming to improve onset, duration, and safety. Novel inhalers and nebulizer-compatible forms are under development.

4. How is the market projected to evolve over the next decade?

The market is expected to grow modestly (~5% CAGR) driven by increasing respiratory disease prevalence, technological innovations, and expanding use in emerging markets.

5. What are the key regulatory considerations for future approvals?

Regulatory agencies are emphasizing safety, especially cardiovascular safety profiles. New formulations and indications require comprehensive clinical data, with approval pathways varying regionally.

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Key Takeaways

• Clinical trials show consistent efficacy of terbutaline sulfate in respiratory and obstetric indications, with ongoing research into safety improvements.
• The global market remains niche, representing approximately 1.2% of the respiratory drugs market, with steady growth driven by environmental and demographic factors.
• Major challenges include safety concerns and competition from newer agents, compelling manufacturers to innovate with inhaled formulations and expanded indications.
• Market growth will depend on the successful development and approval of safer, better-delivered formulations, alongside expanding indications supported by clinical evidence.
• Regulatory agencies' focus on safety will influence future development trajectories, emphasizing the importance of rigorous clinical evaluation.

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References

[1] ClinicalTrials.gov. (2023). Search for 'terbutaline'. Retrieved from https://clinicaltrials.gov/.

[2] Grand View Research. (2022). Respiratory Drugs Market Size, Share & Trends Analysis Report.

[3] Fortune Business Insights. (2022). Preterm Labor Management Market Size & Industry Analysis.