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

Clinical Trial Conditions for halothane

Condition Name

Condition Name for halothane
Intervention	Trials
Long-term Outcome	1
Caudal Block	1
Malignant Tumor	1
Children	1

Condition MeSH

Condition MeSH for halothane
Intervention	Trials
Emergence Delirium	5
Psychomotor Agitation	2
Postoperative Nausea and Vomiting	1
Nausea	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
Benha University	2
University Hospital, Basel, Switzerland	2
Beijing Shijitan Hospital, Capital Medical University	1

Sponsor Type

Sponsor Type for halothane
Sponsor	Trials
Other	29
OTHER_GOV	1

Halothane (inhaled anesthetic) — Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is Halothane and what is its current regulatory footprint?

Halothane is a halogenated inhalational anesthetic used for induction and maintenance of anesthesia. It is widely treated as an established product with long-standing clinical use, but its commercial trajectory is shaped by safety perceptions and regulatory/market shifts toward alternatives (especially newer inhaled anesthetics and balanced anesthesia protocols).

Clinical development status: Halothane is not an active “pipeline drug” in the way new chemical entities are. Its evidence base comes from decades of use, older clinical trial programs, and post-marketing safety literature. Current activity is predominantly pharmacovigilance, label maintenance, and supply-market dynamics rather than new Phase 1-3 trials.

Regulatory reality check that drives market behavior: Halothane’s adoption and commercialization vary by country due to:

• Hepatotoxicity risk signals (historical labeling emphasis and prescriber caution)
• Shift toward isoflurane, sevoflurane, and desflurane in many anesthesia practices
• Product supply concentration (fewer manufacturers over time relative to substitutes)

Are there new clinical trials for Halothane?

Halothane’s public clinical trial presence is dominated by:

• Older randomized and observational studies (pre-modern trial registries in many jurisdictions)
• Non-interventional or registry-based studies (rare in scope for Halothane versus newer anesthetics)
• Safety and comparative effectiveness publications driven by real-world use and pharmacovigilance

Operational takeaway: Treat “clinical trials update” for Halothane as surveillance and comparative evidence refresh, not as a forward-looking Phase 2/3 development program.

What does the clinical evidence say versus modern inhaled anesthetics?

Across the anesthesia literature, the comparative position is consistent:

• Halothane achieves effective anesthesia with predictable pharmacokinetics for its era.
• Its key differentiator in clinical decision-making is safety and tolerability, especially hepatic effects compared with many current standards.

Market implication: Hospitals and anesthesia groups increasingly standardize on agents with more favorable benefit-risk profiles, reducing incremental demand for Halothane except where entrenched formularies, availability, or cost factors sustain use.

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Clinical Trials Update (what is being done today)

What trial types still involve Halothane?

For Halothane, the ongoing “trial-like” activity in the modern era typically clusters into:

• Comparative observational studies in perioperative cohorts (usage patterns, adverse event reporting)
• Safety-focused registry analyses (hepatic adverse events, risk factor characterization)
• Anesthesia technique evaluations where Halothane remains in use locally

What is typically not present: New first-in-human or definitive late-stage efficacy programs for Halothane, because the drug is mature and substitution is routine.

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Market Analysis

Where does Halothane sit in the inhaled anesthetic market?

Halothane is a mature, legacy inhalational anesthetic that competes primarily with:

• Isoflurane
• Sevoflurane
• Desflurane
• Nitrous oxide plus IV anesthetic balancing regimens (as part of overall anesthesia practice rather than direct substitution)

Demand drivers for Halothane

• Formulary inertia in some facilities and regions
• Availability and supply continuity relative to alternatives
• Procurement economics in public systems or low-resource procurement channels
• Clinical practice familiarity in certain geographies

Demand drags

• Safety perception and labeling caution related to hepatotoxicity
• Preferential guideline-driven adoption of other inhaled anesthetics
• Manufacturing concentration risk that can create intermittent shortages or force substitution

Who buys Halothane?

Primary buyers are:

• Hospitals (operating rooms and ambulatory surgery centers where halogenated agents remain in formularies)
• Regional anesthesia service networks that standardize inhaled agents
• Government procurement programs in markets where legacy agents remain part of stocked essential medicines lists

Pricing and competitive dynamics

Halothane’s pricing is usually evaluated against:

• Direct price-per-dose comparisons to isoflurane and sevoflurane
• Cost-of-care integration, where a safer substitution can reduce adverse-event management costs and protocol friction
• Supply stability, where shortfalls shift demand quickly to alternatives

Commercial pattern for legacy anesthetics: pricing power is limited; demand is more sensitive to substitution and procurement decisions than to incremental differentiation.

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Market Projection

What is the likely direction of Halothane volume and revenue?

Base-case commercial trajectory: declining or flat long-term volume in many developed markets, with more stable consumption in select regions where:

• older formularies remain,
• alternatives face procurement barriers,
• and provider habits persist.

Projection framework (directional):

• Developed markets: continued substitution toward isoflurane/sevoflurane/desflurane and balanced anesthesia reduces Halothane share.
• Emerging markets: depends on procurement rules, supply reliability, and whether new anesthetic standards are adopted quickly.

Three-scenario market share view (directional, not numerically calibrated):

• Downside: faster substitution due to guideline updates, supplier consolidation, and safety preference leads to sharper share loss.
• Base case: gradual share erosion continues, but Halothane retains niche use.
• Upside: supply stability plus cost advantages in certain procurement channels slows decline.

Time horizon

• Near term (1-2 years): driven by substitution inertia and supply continuity.
• Mid term (3-5 years): formality tends to tighten as hospitals harmonize protocols and purchasing.
• Long term (5+ years): continued legacy fade unless regulatory access persists and alternatives are constrained.

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Investment and R&D Relevance

Is there a pathway for lifecycle extension?

For established Halothane, “R&D” is typically:

• Manufacturing lifecycle management (scale, formulation presentation, quality)
• Regulatory maintenance (label updates, compliance)
• Supply-chain resilience (ensuring dependable availability)

Strategy reality for business decisions: The primary commercial lever is not new clinical development. It is retaining access and maintaining supply in target geographies while competitors remain easier to source or preferred clinically.

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Key Takeaways

• Halothane is a legacy inhaled anesthetic with clinical evidence that is mature, not a driver of new Phase 1-3 programs.
• Modern clinical practice in many markets favors alternatives with more favorable benefit-risk perceptions, especially around hepatic risk history.
• Demand is sustained mainly by formulary inertia, procurement dynamics, and supply stability rather than new efficacy discovery.
• Market outlook is structurally declining-to-flat in many settings, with pockets of resilience where switching costs and procurement constraints persist.

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FAQs

1. Does Halothane have current Phase 3 efficacy trials?
   Halothane does not function like a new-entity development program; public evidence activity is mostly safety/observational rather than Phase 3 efficacy.

2. What is Halothane’s main market disadvantage versus other inhaled anesthetics?
   Safety perception and historical labeling emphasis around hepatotoxicity reduce preference compared with many current standards.

3. What drives day-to-day demand for Halothane?
   Hospital formularies, procurement rules, alternative availability, and supply continuity.

4. Where is Halothane more likely to remain in use?
   Regions where legacy formularies persist and where substitution barriers (procurement, logistics, inertia) are higher.

5. What is the most actionable commercial lever for Halothane?
   Ensuring consistent supply and regulatory access in target markets while monitoring competitive substitution by isoflurane and sevoflurane.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). FDA label information for halothane (marketed products). FDA.
[2] European Medicines Agency. (n.d.). Product information and regulatory documents for halothane-containing medicines. EMA.
[3] World Health Organization. (n.d.). Essential medicines and anesthesia-related guidance and lists. WHO.
[4] PubMed. (n.d.). Halothane safety and comparative effectiveness publications (search results). National Library of Medicine.