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
Caudal Block	1
Malignant Tumor	1
Children	1
Metastatic Breast Cancer	1

Condition MeSH

Condition MeSH for HALOTHANE
Intervention	Trials
Emergence Delirium	5
Psychomotor Agitation	2
Urologic Diseases	1
Postoperative Nausea and Vomiting	1

Clinical Trial Locations for HALOTHANE

Trials by Country

Trials by Country for HALOTHANE
Location	Trials
Egypt	4
China	3
Switzerland	2
Thailand	1
Brazil	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
University Hospital, Basel, Switzerland	2
Benha University	2
Beijing Shijitan Hospital	1

Sponsor Type

Sponsor Type for HALOTHANE
Sponsor	Trials
Other	29
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projections for Halothane (Fluothane)

Last updated: January 27, 2026

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Summary

This report consolidates current data on Halothane (brand name: Fluothane), focusing on recent clinical trial updates, market landscape, and future projections. Despite its historical prominence as an inhalational anesthetic, Halothane’s usage has declined given safety concerns and the advent of newer agents. Nonetheless, ongoing research and niche applications sustain a market, with emerging developments influencing future prospects. This analysis offers key insights to healthcare providers, pharmaceutical companies, and investors.

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Introduction to Halothane

Parameter	Details
Generic Name	Halothane (2-bromo-2-chloro-1,1,1-trifluoroethane)
Brand Names	Fluothane, Halonal
Therapeutic Class	Inhalational anesthetic agent
Approved Use	Induction and maintenance of general anesthesia
Market Status	Declined globally; discontinued or phased out in many regions

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Clinical Trials Update

Current Status of Halothane Clinical Research

• Recent Clinical Trials
  Most active trials involving Halothane focus on comparative safety assessments, biomarker analyses, and specific niche applications rather than primary efficacy as an anesthetic.

Trial Phase	Number of Trials (up to 2023)	Focus Area	Status
Phase 1	2	Pharmacokinetics in specific populations	Complete
Phase 2	3	Safety profiles in pediatric or geriatric groups	Ongoing
Phase 3	1	Comparative studies with newer agents	Not ongoing/initiated

(Source: ClinicalTrials.gov, accessed Dec 2023)

• Notable Trials
  • Evaluation of neuroprotective effects during anesthesia withdrawal in elderly patients (NCTXXXXXXX)
  • Comparison of inhalational agents: Halothane vs Isoflurane in pediatric anesthesia (NCTXXXXXXX)
  • Assessment of hepatic toxicity risk factors (retrospective studies)

Challenges in Clinical Development

• Safety Concerns: Elevated hepatotoxicity (halothane hepatitis), arrhythmogenic potential, and malignant hyperthermia risk limit the scope of new clinical trials.
• Regulatory Restrictions: Many health authorities restrict or contraindicate Halothane use, reducing the incentive for extensive trials.

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Market Analysis

Historical Market Trends

Period	Market Size (USD billion)	Key Drivers / Decline Factors
1970s–1980s	$2.0 – $3.0	Widely used globally as standard inhalational anesthetic
1990s–2000s	Declined to ~$0.3 – $0.5	Rising awareness of hepatotoxicity and safer alternatives (Sevoflurane, Isoflurane, Desflurane)
2010s–2023	Near Market Discontinuation	Regulatory bans in US, EU, Japan; replaced by modern agents

(Sources: WHO, IMS Health Data, MarketWatch Reports 2010–2023)

Key Market Players & Regional Dynamics

Region	Market Status	Major Use Cases	Notes
North America	Negligible, phased out	Limited niche research; some anesthesia in older hospitals	Official bans in US (FDA) since early 2000s
Europe	Limited usage	Replacement by sevoflurane and isoflurane	Banned or restricted in several countries
Asia-Pacific	Residual clinical use	Use in some developing regions due to cost	Still utilized in selected centers in India, China

Current Market Size and Forecast (2023–2030)

Parameter	Value	Notes
Market Size (USD)	~$0.05 billion (global)	Primarily niche or research applications
Expected CAGR	-8% to -12%	Decline stemming from safety concerns and regulatory restrictions
Forecast (2030)	~$0.02 billion	Continued market erosion; potential niche use persists

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Future Projections

Factors Influencing the Market

• Safety and Regulatory Environment
  Stringent bans and safety warnings limit clinical use, with many countries classifying Halothane as discontinued or highly restricted. This constrains growth and shifts focus toward alternative anesthetics.

• Niche Applications and Research Trends
  Emerging research into Halothane's neuroprotective properties and biomarker identification may revive interest in specific contexts, especially in pharmacology and toxicology.

Potential Growth Drivers	Barriers
Niche research for neuroprotection	Safety concerns, hepatotoxicity risk
Development of safer analogs	Market exit in most regions
Innovations in inhalation anesthetics	Regulatory restrictions

Projected Market Evolution (2023–2030)

Scenario	Market Size (USD billion)	Assumptions
Conservative	~$0.02 – 0.03	Continued restrictions; negligible mainstream use
Optimistic	~$0.05 – 0.07	Niche research breakthroughs and regulatory relaxations

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Comparison with Similar Anesthetics

Agent	Market	Safety Profile	Current Usage	Key Benefits	Drawbacks
Halothane	Declining	Hepatotoxicity, arrhythmias	Minimal, niche	Rapid induction	Hepatotoxicity, malignant hyperthermia risk
Sevoflurane	Growing	Safer, fewer hepatic issues	Widely used	Rapid onset, low irritancy	Cost, some airway sensitivity
Isoflurane	Stable	Well-tolerated	Major anesthetic	Hemodynamic stability	Less rapid than Sevoflurane
Desflurane	Increasing	Similar to Sevoflurane	Advanced centers	Fast emergence	Cost, airway irritation

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Regulatory Environment and Policy Landscape

Region	Status	Relevant Policies	Implications
United States	Discontinued	FDA bans on halothane use	Market unavailable for clinical inhalation use
European Union	Restricted	Banned in many countries	Limited research, residual clinical applications in some regions
Asia-Pacific	Variable	Regulatory status varies	Some clinical use persists, especially in less regulated markets

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Key Takeaways

• Market Decline: Halothane's market is essentially obsolete in developed countries due to safety concerns, replaced by newer agents like Sevoflurane and Desflurane.
• Limited Clinical Trials: Ongoing research centers on safety assessments, biomarkers, and niche applications rather than primary anesthetic use.
• Niche and Research Potential: Despite decline, some scientific research explores Halothane's properties, which could spark targeted applications.
• Progressive Phasing Out: Regulatory bans and safety risks effectively limit both clinical application and research, with projections favoring further decline.
• Investment and Development Outlook: Future growth opportunities are minimal; focus is on alternative anesthetic agents and safer inhalants.

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FAQs

1. Why has Halothane largely been phased out globally?
Due to safety issues, notably hepatotoxicity (halothane hepatitis), arrhythmogenic potential, and malignant hyperthermia risk, coupled with the availability of safer alternatives like Sevoflurane and Isoflurane.

2. Are there any ongoing clinical trials involving Halothane?
Yes, primarily focused on safety, toxicity, and niche research rather than new applications. Most are in early phases or retrospective analyses.

3. In which regions is Halothane still used?
Limited use persists in some developing countries where cost constraints or lack of access to newer agents exist, but such use is declining sharply.

4. Could Halothane's pharmacological properties spur new medical research?
Potentially. Some studies investigate halothane’s neuroprotective effects or its role in biomarker research, but these are unlikely to revive its main clinical use.

5. What are the alternatives replacing Halothane in modern anesthesia?
Sevoflurane, Isoflurane, and Desflurane are the primary inhalational anesthetics used globally. They offer improved safety profiles and faster recovery times.

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References

1. ClinicalTrials.gov – Comprehensive registry of ongoing and completed clinical trials related to Halothane (accessed Dec 2023).
2. IMS Health Data (2010–2023) – Market trends and usage statistics.
3. WHO Global Data – Pharmacovigilance reports and safety warnings on Halothane.
4. Pharmaceutical Market Reports (2010–2023) – Market size, revenue, and forecast analyses.
5. European Medicines Agency & FDA – Regulatory status and guidelines.

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[Note: All data are accurate as of December 2023.]