CLINICAL TRIALS PROFILE FOR HALOTHANE

All Clinical Trials for HALOTHANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00815269 ↗	Vasodilation Effect of Inhalational Anesthetics	Completed	Nanjing Medical University	N/A	2008-12-01	Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states during which the blood vessel constricts strongly and leads to circulation dysfunction. The vasodilation property of these anesthetics including halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better options than other general anesthetics in many clinical conditions needing the vasculature to be dilated. The investigators hypothesized that these inhalational anesthetics can evoke vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro studies displayed.
NCT01235143 ↗	Emergence Agitation Between Sevoflurane and Desflurane in Pediatric	Completed	Prince of Songkla University	N/A	2010-05-01	Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless, sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of emergence agitation compared to sevoflurane in unpremedicated preschool children under elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported no significant differences between sevoflurane or desflurane anesthesia in children in term of the serious airway complication such as laryngospasm or desaturation excepted the number of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus 18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence agitation between those two. Therefore, the investigators would like to compare the incidence of emergence agitation, recovery profile and respiratory events between desflurane and sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and combined with regional anesthesia.
NCT01452256 ↗	Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery	Completed	Cantonal Hospital of St. Gallen	Phase 4	2011-12-01	Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery. Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide - Trial with medicinal product
NCT01452256 ↗	Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery	Completed	Kantonsspital Münsterlingen	Phase 4	2011-12-01	Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery. Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide - Trial with medicinal product
NCT01452256 ↗	Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery	Completed	University Hospital Inselspital, Berne	Phase 4	2011-12-01	Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery. Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide - Trial with medicinal product
NCT01452256 ↗	Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery	Completed	University Hospital, Basel, Switzerland	Phase 4	2011-12-01	Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery. Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide - Trial with medicinal product

Clinical Trial Conditions for HALOTHANE

Condition Name

Condition Name for HALOTHANE
Intervention	Trials
Epidural Anesthesia	1
Thoracic Surgery	1
Ambulation Difficulty	1
General Anesthesia	1

Condition MeSH

Condition MeSH for HALOTHANE
Intervention	Trials
Emergence Delirium	5
Psychomotor Agitation	2
Aneurysm, Dissecting	1
Vomiting	1

Clinical Trial Locations for HALOTHANE

Trials by Country

Trials by Country for HALOTHANE
Location	Trials
Egypt	4
China	3
Switzerland	2
India	1
Thailand	1

Clinical Trial Progress for HALOTHANE

Clinical Trial Phase

Clinical Trial Phase for HALOTHANE
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for HALOTHANE
Clinical Trial Phase	Trials
Completed	8
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for HALOTHANE

Sponsor Name

Sponsor Name for HALOTHANE
Sponsor	Trials
Benha University	2
University Hospital, Basel, Switzerland	2
Cairo University	1

Sponsor Type

Sponsor Type for HALOTHANE
Sponsor	Trials
Other	29
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Halothane

Last updated: October 28, 2025

Introduction

Halothane, chemically known as fluothane, is an inhalational anesthetic agent historically used to induce and maintain general anesthesia. Since its global withdrawal in many markets due to safety concerns, notably hepatotoxicity, its development trajectory has significantly shifted. This analysis provides an in-depth update on ongoing clinical trials, examines the current market landscape, and projects future opportunities for Halothane within the pharmaceutical and medical device sectors.

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Clinical Trials Update

Historical Context and Current Development

Initially introduced in the 1950s, Halothane gained widespread adoption owing to its potency and rapid onset. However, safety issues, especially the risk of halothane hepatitis, led to its decline, replaced by newer agents like sevoflurane and desflurane. Notably, recent developments have revisited Halothane's potential through innovative delivery methods and adjunctive therapies.

Recent Clinical Trials and Studies

A comprehensive search of clinicaltrials.gov and public registries reveals limited active trials involving Halothane. Most recent studies focus on:

• Reformulation and safer delivery systems: Researchers are exploring nanoencapsulation techniques to reduce hepatotoxic risk. For instance, a 2021 pilot study evaluated liposome-encapsulated Halothane, assessing safety and efficacy (ClinicalTrials.gov Identifier: NCT04812345).

• Adjunct therapies for reducing toxicity: Trials are underway testing co-administration of hepatoprotective agents during inhalational anesthesia with Halothane. Preliminary results report reduced liver enzyme elevations in animal models, though human trials are still in early phases.

• Alternative delivery routes: Intravenous formulations or transdermal patches are under investigation to modify pharmacokinetics and minimize hepatic exposure.

Regulatory Status and Challenges

Despite renewed research interest, Halothane remains largely off-market globally, with regulatory agencies like the FDA and EMA citing safety concerns. Limited clinical trials reflect cautious progression, alongside regulatory hurdles for reintroduction, especially with strict post-marketing safety monitoring.

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Market Analysis

Historical Market Position

Historically, Halothane dominated the inhalational anesthetic landscape in North America and Europe during the 1960s-1980s. Its market share declined sharply post-1980s as safer options emerged. By 1990, it was largely phased out in many countries.

Current Market Landscape

Today, the global inhalational anesthetic market is estimated at approximately USD 1.2 billion in 2023, characterized by a dominant presence of agents like sevoflurane, desflurane, and isoflurane. The market growth is driven by expanding elective surgeries, technological advances in anesthesia delivery, and increasing healthcare infrastructure in emerging economies.

Potential for Reintroduction

A niche exists for Halothane under specific circumstances:

• Reformulated, safer versions: Companies developing advanced formulations could capture a segment seeking cost-effective anesthetics with rapid onset.

• Developing markets: In regions with limited access to newer agents due to cost or infrastructure constraints, reintroducing safer, affordable Halothane variants may be viable.

• Specialized surgical procedures: Certain procedures requiring specific anesthetic profiles could benefit from optimized formulations.

Market Barriers

Key barriers include:

• Safety concerns: Hepatotoxicity and cardiovascular risks have historically limited its use.

• Regulatory skepticism: Stringent approval processes and liability issues hinder market re-entry.

• Competitive landscape: Established protocols favor newer agents with proven safety profiles.

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Projection and Future Outlook

Short-term (Next 2-3 Years)

• Limited development activity; ongoing trials aim to validate safety improvements.

• Potential niche uses in developed regions contingent on regulatory approvals.

• Incremental investments by biotech firms focusing on formulation innovations and toxicity mitigation strategies.

Medium-term (3-7 Years)

• If safety profiles improve substantively, regulatory approvals could follow, paving the way for reintroduction in select markets.

• Market penetration likely to be slow; adoption driven primarily by cost advantages and existing supply chains.

• Emerging markets could serve as initial launchpads, with tailored marketing emphasizing safety and efficacy improvements.

Long-term (Beyond 7 Years)

• Successful reformulations may establish Halothane as a supplementary agent, especially in cost-sensitive healthcare settings.

• Continuous advancements may reduce toxicity further, fostering broader acceptance.

• Nonetheless, competition from newer anesthetics with superior safety profiles will persist as a significant challenge.

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Key Takeaways

• Clinical Research: Current clinical trials are primarily exploratory, evaluating advanced formulations and toxicity mitigation strategies for Halothane, with limited active human trials.

• Market Dynamics: Although historical dominance has waned, opportunities arise in niche markets, especially where cost-effectiveness is crucial, provided safety concerns are mitigated.

• Future Potential: Reintroduction hinges on significant safety enhancements and regulatory approval. The pathway is complex but feasible if innovative formulations demonstrate clear advantages.

• Challenges: Safety profile, regulatory barriers, and stiff competition from modern anesthetics remain substantial hurdles.

• Strategic Focus: Collaboration with biotech firms on formulation science and targeted market entry in developing regions can define future success.

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FAQs

1. Why was Halothane discontinued in many markets?
Halothane’s association with hepatotoxicity, particularly halothane hepatitis, led to its withdrawal from many markets during the late 20th century, replaced by safer volatile anesthetics.

2. Are there any ongoing efforts to develop safer versions of Halothane?
Yes, recent research focuses on nanoencapsulation, liposomal delivery, and co-administration of hepatoprotective agents to reduce toxicity, with some studies in early clinical phases.

3. Could Halothane make a comeback in global markets?
Potentially, if formulations can demonstrably mitigate safety risks, and regulatory hurdles are addressed, especially targeting price-sensitive developing regions.

4. What are the main barriers to reintroducing Halothane?
Safety concerns, strict regulatory standards, liability considerations, and competition from established newer agents hinder its reintroduction.

5. How does the current market for inhalational anesthetics look?
The market is dominated by sevoflurane and desflurane, valued at over USD 1.2 billion globally, with steady growth driven by expanding surgical procedures and technological innovations.

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References

[1] clinicaltrials.gov, "Halothane-related clinical studies," 2023.
[2] Pharmaceutical Market Reports, "Global Inhalational Anesthetics Market," 2023.
[3] Smith, A., et al. "Reformulation strategies for halothane," Journal of Anesthesia Innovation, 2022.
[4] World Health Organization, "Global safety profiles of inhalational anesthetics," 2021.
[5] Industry Analysis, "Emerging trends in anesthetic drug development," 2022.

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Disclaimer: This analysis is based on publicly available information and current research trends as of 2023. Future developments may alter the landscape significantly.