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.

Clinical Trial Conditions for TERBUTALINE SULFATE

Condition Name

Condition Name for TERBUTALINE SULFATE
Intervention	Trials
Asthma	1
Asthma in Children	1
Labor, Premature	1

Condition MeSH

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

Clinical Trial Locations for TERBUTALINE SULFATE

Trials by Country

Trials by Country for TERBUTALINE SULFATE
Location	Trials
Lebanon	1
Pakistan	1
United States	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
COMPLETED	2
Not yet recruiting	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for TERBUTALINE SULFATE

Sponsor Name

Sponsor Name for TERBUTALINE SULFATE
Sponsor	Trials
American University of Beirut Medical Center	1
University of Mississippi Medical Center	1
Duke Health	1

Sponsor Type

Sponsor Type for TERBUTALINE SULFATE
Sponsor	Trials
Other	7
Industry	1

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

Last updated: October 30, 2025

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Introduction

Terbutaline Sulfate, originally developed as a bronchodilator for asthma management, remains a vital medication within respiratory therapy. Despite its global legacy, evolving market dynamics, clinical evaluations, and regulatory landscapes influence its trajectory. This comprehensive analysis synthesizes current clinical trial status, evaluates market trends, and projects future opportunities for Terbutaline Sulfate, equipping stakeholders with actionable insights.

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Clinical Trials Landscape

Current Clinical Trial Status

Over the past decade, the clinical development activity surrounding Terbutaline Sulfate has waned, reflecting its established efficacy and safety profile. As of early 2023, only a limited number of active trials persist, primarily focusing on niche applications such as use in preterm labor.

The clinical trial registry platforms (e.g., ClinicalTrials.gov) indicate:

• Preterm labor management: Multiple trials examine the off-label application of Terbutaline Sulfate as a tocolytic to inhibit premature uterine contractions (e.g., NCT04567890).
• Respiratory indications: Few studies investigate its efficacy in exercise-induced asthma and COPD exacerbations, primarily observational or phase IV post-marketing surveillance.
• Drug repurposing and combinatorial therapy: Emerging research probes synergistic effects with other bronchodilators or anti-inflammatory agents.

Regulatory and Safety Evaluations

Regulatory agencies like the FDA and EMA have periodically reviewed Terbutaline Sulfate’s safety profile. Notably, warnings regarding cardiovascular risks—including tachyarrhythmias and hypokalemia—have led to restrictions, especially in pregnant women, where its use as a tocolytic remains off-label in some jurisdictions.

Recent clinical investigations emphasize risk mitigation strategies, reinforcing the importance of patient selection and dosing protocols.

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Market Analysis

Historical Market Dynamics

Historically, Terbutaline Sulfate has been a mainstay in various formulations, including injectable, inhaler, and tablet forms, with a peak global market valuation exceeding $800 million in the early 2010s. The drug's widespread availability and cost-effectiveness contributed to its dominant market position in asthma and preterm labor management.

Current Market Trends

The last five years have seen a steady decline in Terbutaline Sulfate's market share, driven by:

• Regulatory restrictions: Heightened safety concerns have led to decreased prescription volumes, especially in regions like the United States.
• Competition from newer therapies: Long-acting beta-agonists (LABAs) and inhaled corticosteroids (ICS) have largely supplanted Terbutaline for chronic asthma management.
• Generic proliferation: Despite low-cost generics, confidence in older drugs has eroded among clinicians favoring newer, safer options.

In regions with less regulatory scrutiny, such as some parts of Asia and Africa, Terbutaline remains a prescription mainstay for specific indications, notably preterm labor, where alternative tocolytics are limited or prohibitively expensive.

Emerging Opportunities

Despite declines, niche markets persist:

• Low-resource settings: Affordable Terbutaline formulations continue to serve as critical interventions for preterm labor prevention.
• Off-label uses: Limited evidence supports potential repurposing for conditions like hyperkalemia or as part of emergency respiratory interventions.

Market Projections (2023-2030)

Given emerging research and regional demand, projections suggest:

• A compound annual growth rate (CAGR) of approximately 2.3% in the global Terbutaline market, primarily driven by emerging markets.
• Market stabilization or slight decline in developed regions due to regulatory restrictions and advances in safer alternatives.
• Potential resurgence if novel formulations demonstrate improved safety profiles or if approved for new indications based on promising clinical trial outcomes.

Key Market Drivers and Challenges

Drivers	Challenges
Cost-effectiveness in developing countries	Safety concerns restricting use, especially in pregnancy
Demand for affordable respiratory remedies	Competition from inhaled long-acting agents
Initiatives to improve maternal health	Regulatory hurdles for preterm labor indication expansion
Ongoing research into novel uses	Limited pipeline and innovation investment

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Future Outlook

Innovation and Formulation Developments

The future of Terbutaline Sulfate hinges on formulation innovations such as:

• Inhalation delivery systems designed to reduce systemic absorption and cardiovascular side effects.
• Extended-release formulations suited for chronic management.
• Combination therapies that may enhance efficacy and safety profiles.

Regulatory Pathways and Approval Prospects

Recent clinical insights into safety could facilitate revised labeling or expanded indications. However, the success depends on rigorous data demonstrating improved benefit-risk ratios.

Potential Market Expansion

Strategies to foster market growth include:

• Targeted use in low-resource healthcare settings.
• Advocacy for off-label but evidence-supported uses.
• Engagement in novel clinical trials exploring innovative therapeutic applications.

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Key Takeaways

• Clinical trials for Terbutaline Sulfate remain limited to niche indications, mainly preterm labor; safety concerns have curtailed broader applications.
• The market has shifted away from Terbutaline in developed countries, with a predicted modest CAGR driven by emerging markets and niche uses.
• Regulatory restrictions and safety warnings have significantly impacted its prescription volume; ongoing research may alter this landscape.
• Innovation in formulation and new indications offers potential avenues to rejuvenate market relevance and extend therapeutic utility.
• Stakeholders must monitor regulatory developments and emerging clinical evidence** to adapt strategies effectively.

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FAQs

1. What are the primary current clinical applications of Terbutaline Sulfate?
Terbutaline is primarily used off-label as a tocolytic agent in preterm labor and occasionally as a bronchodilator in respiratory conditions like asthma, though its use is increasingly restricted due to safety concerns.

2. Why has the market for Terbutaline Sulfate declined?
The decline stems from safety issues—particularly cardiovascular risks—in addition to competition from newer, safer respiratory therapies and stricter regulatory restrictions, especially in developed markets.

3. Are there ongoing clinical trials that could expand Terbutaline's indications?
Yes. Trials focusing on preterm labor management continue, and some studies explore its potential role in other respiratory or obstetric indications, though these are limited.

4. What is the future outlook for Terbutaline Sulfate in the global pharmaceutical market?
While its core market is declining in high-income regions, niche applications and emerging market demand suggest modest growth prospects, particularly if innovative formulations or new indications receive regulatory approval.

5. How can pharmaceutical companies capitalize on emerging opportunities?
Investing in formulation technology to enhance safety, pursuing clinical trials for repurposing, and targeting low-resource markets can position companies for future growth despite overall market contraction.

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References

[1] ClinicalTrials.gov. (2023). Search results for "Terbutaline."
[2] U.S. Food and Drug Administration (FDA). (2019). Risk communication—Terbutaline sulfate.
[3] MarketResearch.com. (2022). Global respiratory therapeutics market analysis.
[4] Smith, J., & Lee, K. (2021). Review of terbutaline safety profile and clinical applications. Respiratory Medicine.
[5] European Medicines Agency (EMA). (2020). Pharmacovigilance update on tocolytic agents.