You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR LABETALOL HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Labetalol Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed University of Minnesota Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000297 ↗ Effects of Labetalol on Nicotine Administration in Humans - 14 Completed University of Minnesota Phase 2 1998-10-01 The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
NCT00000297 ↗ Effects of Labetalol on Nicotine Administration in Humans - 14 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1998-10-01 The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Labetalol Hydrochloride

Condition Name

Condition Name for Labetalol Hydrochloride
Intervention Trials
Hypertension in Pregnancy 7
Preeclampsia 6
Hypertension 6
Hypertension, Pregnancy-Induced 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Labetalol Hydrochloride
Intervention Trials
Hypertension 23
Pre-Eclampsia 21
Hypertension, Pregnancy-Induced 16
Eclampsia 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Labetalol Hydrochloride

Trials by Country

Trials by Country for Labetalol Hydrochloride
Location Trials
United States 40
Egypt 11
Canada 7
China 2
Pakistan 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Labetalol Hydrochloride
Location Trials
New York 11
Ohio 4
California 4
Texas 3
Tennessee 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Labetalol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Labetalol Hydrochloride
Clinical Trial Phase Trials
Phase 4 24
Phase 3 6
Phase 2/Phase 3 2
[disabled in preview] 21
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Labetalol Hydrochloride
Clinical Trial Phase Trials
Completed 28
Recruiting 13
Unknown status 8
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Labetalol Hydrochloride

Sponsor Name

Sponsor Name for Labetalol Hydrochloride
Sponsor Trials
Weill Medical College of Cornell University 3
University of Alberta 3
Mansoura University 3
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Labetalol Hydrochloride
Sponsor Trials
Other 83
U.S. Fed 4
NIH 4
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Labetalol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Labetalol Hydrochloride

Labetalol hydrochloride is a versatile antihypertensive drug that combines both alpha-1 adrenergic and beta-adrenergic blocking activities. It is widely used to manage hypertension, angina, and sympathetic overactivity syndrome. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Clinical Trials Experience

Clinical trials for labetalol hydrochloride have been extensive and varied. These trials have included studies with daily doses up to 2,400 mg in severely hypertensive patients. In controlled clinical trials lasting 3 to 4 months, labetalol hydrochloride demonstrated its efficacy in managing hypertension. However, these trials also highlighted several adverse reactions that led to the discontinuation of the drug in about 7% of all patients[1].

Adverse Reactions

The most common adverse reactions reported in clinical trials include dizziness (11%), nausea (6%), fatigue (5%), headache (2%), and dyspnea (2%). These reactions were more frequent in patients treated with labetalol hydrochloride compared to those receiving a placebo[1].

Special Considerations

Labetalol hydrochloride has specific considerations for certain patient groups. For instance, it can be used in patients with pheochromocytoma, but with caution and under close supervision. Additionally, there is a risk of severe acute hypersensitivity reactions and hepatic injury, which necessitates careful monitoring[1].

Pregnancy and Lactation

Extensive experience with labetalol hydrochloride in pregnant women has not identified a significant drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, studies have methodological limitations, and the risk cannot be definitively ruled out. Animal studies have shown no reproducible evidence of fetal malformations, but increased fetal resorptions were observed at doses approximating the maximum recommended human dose[1].

Pharmacodynamics and Mechanism of Action

Labetalol hydrochloride works by non-selectively antagonizing beta-adrenergic receptors and selectively antagonizing alpha-1 adrenergic receptors. This dual action leads to vasodilation and decreased vascular resistance, resulting in a decrease in blood pressure. The beta-blocking activity also slightly decreases heart rate. The drug's pharmacodynamic profile is characterized by a higher beta-blocking to alpha-blocking ratio, especially after intravenous administration[3][4].

Market Analysis

Current Market Status

The labetalol hydrochloride market has experienced rapid and substantial growth in recent years. The market size was significant in 2023 and is anticipated to continue growing significantly until 2031. This growth is driven by increasing demand for effective antihypertensive medications and the expanding global healthcare market[2][5].

Market Dynamics

The market dynamics for labetalol hydrochloride are influenced by several factors:

  • Drivers: Increasing prevalence of hypertension, growing awareness of cardiovascular health, and advancements in pharmaceutical technology.
  • Restraints: Side effects associated with the drug, competition from other antihypertensive medications, and regulatory challenges.
  • Opportunities: Expanding into emerging markets, developing new formulations, and potential applications in other therapeutic areas.
  • Challenges: Economic fluctuations, changes in healthcare policies, and the need for continuous innovation to stay competitive[2][5].

Key Players and Segmentation

The market is segmented based on product type, application, and geography. Key players in the labetalol hydrochloride market are focusing on product differentiation, strategic partnerships, and expanding their distribution networks. The segmentation analysis helps in understanding the market's diverse needs and opportunities across different regions and end-use industries[2][5].

Market Projections

Revenue Growth

The labetalol hydrochloride market is projected to achieve robust growth rates from 2023 to 2031. The revenue is expected to increase significantly, driven by the increasing demand for antihypertensive medications and the growing global population with hypertension. The market study provides a detailed outlook on the revenue growth throughout the forecast period[2][5].

Regional Outlook

The market growth is expected to be prominent in regions with high prevalence of hypertension and well-developed healthcare systems. North America, Europe, and Asia-Pacific are anticipated to be key regions driving the market growth. Emerging markets in Latin America, Africa, and the Middle East also offer significant opportunities for expansion[2][5].

Key Takeaways

  • Clinical Efficacy: Labetalol hydrochloride has been shown to be effective in managing hypertension and other cardiovascular conditions through extensive clinical trials.
  • Adverse Reactions: Common adverse reactions include dizziness, nausea, fatigue, and dyspnea, which need careful monitoring.
  • Market Growth: The market is expected to grow significantly from 2023 to 2031, driven by increasing demand and expanding healthcare needs.
  • Market Dynamics: The market is influenced by drivers such as growing awareness of cardiovascular health, restraints like side effects, and opportunities in emerging markets.
  • Pharmacodynamics: The drug's dual action on alpha-1 and beta-adrenergic receptors makes it a versatile treatment option for hypertension.

FAQs

What is the primary use of labetalol hydrochloride?

Labetalol hydrochloride is primarily used to manage hypertension, angina, and sympathetic overactivity syndrome.

What are the common adverse reactions associated with labetalol hydrochloride?

Common adverse reactions include dizziness, nausea, fatigue, headache, and dyspnea.

Can labetalol hydrochloride be used during pregnancy?

While extensive experience has not identified a significant drug-associated risk, the risk cannot be definitively ruled out due to methodological limitations in studies.

How does labetalol hydrochloride work?

Labetalol hydrochloride works by non-selectively antagonizing beta-adrenergic receptors and selectively antagonizing alpha-1 adrenergic receptors, leading to vasodilation and decreased vascular resistance.

What are the market projections for labetalol hydrochloride?

The market is projected to achieve robust growth rates from 2023 to 2031, driven by increasing demand for antihypertensive medications and expanding healthcare needs.

Sources

  1. Labetalol Hydrochloride Tablets - FDA Labeling[1]
  2. Global Labetalol Hydrochloride API Market - Market Research Intellect[2]
  3. Labetalol Hydrochloride Injection - Pfizer Labeling[3]
  4. Labetalol - DrugBank Online[4]
  5. Global Labetalol HCL Market - Market Research Intellect[5]

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.