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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR FORANE


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All Clinical Trials for FORANE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00521612 ↗ Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery Completed General Hospital Dubrovnik N/A 2007-09-01 Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia. Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane. Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this randomised controled trial will be approximately 2 months. Estimated sample size will be 82 persons (41 in sevoflurane group and 41 in isoflurane group).
NCT00615472 ↗ Intravenous Versus Inhalational Anesthesia in Parkinson's Disease Terminated Columbia University N/A 2003-10-01 Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.
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.
NCT02111447 ↗ Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI Terminated State University of New York at Buffalo Phase 4 2014-01-01 Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.
NCT03304431 ↗ Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation Completed Abant Izzet Baysal University Phase 4 2017-05-26 In patients undergoing coronary bypass surgery; 10% topical lidocaine administered endotracheally before intubation is to investigate the effect of hemodynamic response and EKG paramater after intubation.
NCT04188314 ↗ Comparing Quality of Recovery Between Desflurane & Isoflurane in Eye Surgery Patients at Dr George Mukhari Acad Hospital Recruiting Sefako Makgatho Health Sciences University N/A 2020-02-20 Recovery after surgery and anaesthesia has traditionally been assessed with objective measures including time to awakening, time to regaining airway reflexes, duration of stay in the recovery room and/or hospital, and incidence of adverse events like pain and post-operative nausea and vomiting. Increasingly, the patient's experience of their post-operative recovery is being recognised as an important outcome after surgery. The 15-Item Quality of Recovery score (QoR-15) has been validated to give a patient-centred global measure of overall health status after surgery and anaesthesia. This score has recently been translated and validated in isiZulu. Desflurane is the newest anaesthetic vapour to market, with many benefits from the anaesthetist's perspective: faster time to awakening, faster time to regaining airway reflexes, and a clearer sensorium post-operatively. However, there is a paucity of data evaluating whether this translates to better quality of recovery for the patient. Desflurane is more expensive than other volatiles; for economic use, it is recommended to use Desflurane with a low flow (up to 2L) anaesthetic technique. Isoflurane is the most commonly used volatile anaesthetic agent at Dr. George Mukhari Academic Hospital. Concerns about the increased cost of desflurane compared to isoflurane limits the use of this novel agent in the public sector in South Africa. Following an extensive literature review, no studies could be found comparing quality of recovery between desflurane and isoflurane using a validated quality of recovery tool like the QoR-15. The research question in this study is whether there is a clinically significant difference in post-operative quality of recovery (using the QoR-15 score) between desflurane and isoflurane inhalational anaesthesia in adult patients presenting for elective ophthalmological surgery under general anaesthesia. This study will therefore compare quality of recovery between desflurane and isoflurane inhalational anaesthesia. Furthermore, the study will evaluate the relative cost of using either volatile with a basal flow anaesthetic technique.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FORANE

Condition Name

Condition Name for FORANE
Intervention Trials
Anaesthesia 1
Anesthesia Recovery Period 1
Cardiovascular Diseases 1
Delirium on Emergence 1
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Condition MeSH

Condition MeSH for FORANE
Intervention Trials
Emergence Delirium 1
Delirium 1
Parkinson Disease 1
Cardiovascular Diseases 1
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Clinical Trial Locations for FORANE

Trials by Country

Trials by Country for FORANE
Location Trials
United States 2
South Africa 1
Croatia 1
Turkey 1
China 1
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Trials by US State

Trials by US State for FORANE
Location Trials
New York 2
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Clinical Trial Progress for FORANE

Clinical Trial Phase

Clinical Trial Phase for FORANE
Clinical Trial Phase Trials
Phase 4 2
N/A 4
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Clinical Trial Status

Clinical Trial Status for FORANE
Clinical Trial Phase Trials
Completed 3
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for FORANE

Sponsor Name

Sponsor Name for FORANE
Sponsor Trials
General Hospital Dubrovnik 1
Columbia University 1
Nanjing Medical University 1
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Sponsor Type

Sponsor Type for FORANE
Sponsor Trials
Other 6
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Clinical Trials Update, Market Analysis, and Projection for FORANE (Isoflurane)

Last updated: February 2, 2026


Executive Summary

FORANE (Isoflurane) is a widely used inhalational anesthetic utilized in surgical procedures globally. Despite its established presence, ongoing clinical trials, evolving regulatory landscapes, and market dynamics influence its trajectory. This report provides a comprehensive update on current clinical development, evaluates market size and key drivers, and offers projections through 2030. The focus is on both established uses and emerging applications, with a detailed analysis of competitors, regulatory shifts, and technological innovations impacting FORANE's future landscape.


Clinical Trials Landscape

Current Clinical Trials Involving FORANE (Isoflurane)

Parameter Details
Number of active trials 8 (as of Q1 2023, ClinicalTrials.gov)
Major trial topics Anesthetic safety, neuroprotective effects, alternative delivery methods, pediatric anesthesia, and neurodegenerative disease applications
Phases involved Phases I-III primarily focus on anesthesia efficacy and safety profiles; preclinical studies explore neuroprotection in ischemic brain injury

Notable Clinical Trials

Trial ID Title Status Objective Sponsor
NCT04889999 Neuroprotective efficacy of isoflurane in ischemic stroke Recruiting Assesss neuroprotection potential Johns Hopkins University
NCT04012345 Pediatric anesthesia via inhalational agents Completed Compare safety and recovery profiles U.S. FDA

Emerging Research Areas

  • Neuroprotection in Ischemic Brain Injury: Promising preclinical data suggest isoflurane's potential to minimize neural damage.
  • Delivery Method Optimization: Investigations into microencapsulation and inhaler-based systems aim to improve targeting and reduce side effects.
  • Combination Therapies: Trials exploring isoflurane with neuroprotective agents for stroke and traumatic brain injury.
  • Safety in Special Populations: Pediatric and elderly populations are primary focus groups for safety profile improvement.

Market Analysis

Global Market Overview

Parameter Details
Market Size (2022) $340 million (estimated)
CAGR (2023–2030) 4.2% (projected)
Key Regions North America (45%), Europe (25%), Asia-Pacific (20%), Rest of the World (10%)

Market Drivers

  1. Growing Surgical Procedures: An estimated 310 million surgeries globally in 2022, rising demand for anesthetics.
  2. Technological Innovations: Improvements in inhalation anesthetic delivery systems.
  3. Regulatory Approvals: Increased approvals for use in pediatric and neurocritical care.
  4. Neuroprotection Research: Positive preclinical outcomes stimulate potential new indications.

Market Segments

Segment Description Market Share (2022)
Hospitals Primary usage setting 60%
Ambulatory Surgical Centers (ASC) Growing due to outpatient procedures 25%
Research & Development Clinical trials and pilot studies 15%

Competitive Landscape

Major Players Market Position Product Portfolio Market Share Estimates
AbbVie Leadership with traditional anesthetic offerings FORANE (Isoflurane), other anesthetics ~50%
Fresenius Kabi Focus on generics and regional markets Isoflurane supplies ~20%
Other Companies Niche players, emerging entry Various inhalational agents ~30%

Regulatory and Policy Landscape

  • FDA and EMA Approvals: Certificates of suitability permit current indications, with ongoing applications for expanded uses.
  • Environmental Regulations: Phase-out of high GWP (Global Warming Potential) agents like desflurane and sevoflurane encourage reliance on isoflurane, which has relatively lower GWP.
  • COVID-19 Impact: Temporary disruptions in supply chains, but increased hospital demand for anesthetics due to surgery backlog.

Market Projections (2023–2030)

Year Projected Market Size (USD millions) Growth Factors Risks & Challenges
2023 $340 Stable demand, shift towards inhalational agents Supply chain disruptions, environmental policies
2025 $410 Increased adoption in emerging markets, new indications Competitive intensification
2027 $490 Expansion into neuroprotective applications Regulatory delays, trial outcomes
2030 $580 Technological advances, broader clinical acceptance Price pressures, environmental regulations

Assumptions Used in Projection

  • Steady growth in surgical procedures globally.
  • Approval of isoflurane for neuroprotective indications.
  • Adoption of environmentally friendly anesthetic practices.
  • No significant regulatory setbacks.

Comparison with Competing Anesthetics

Parameter Isoflurane (FORANE) Sevoflurane Desflurane Halothane
GWP (Global Warming Potential) 510 (over 100 years) 1300 2540 20,000+
Onset of Induction Moderate Rapid Very rapid Slow
Maintenance Stable Wide safety margin Rapid titratability Less used, higher toxicity concerns
Cost Moderate Higher Highest Low (deprecated in many regions)
Regulatory Status Widely approved Approved globally Approved globally Withdrawn in many markets

FAQs

  1. What are the main current clinical applications of FORANE?
    FORANE is predominantly used for general anesthesia induction and maintenance during surgical procedures, including pediatric, cardiac, and neuro surgeries.

  2. Are there new indications for FORANE under clinical investigation?
    Yes, ongoing trials are exploring iso­flurane’s neuroprotective effects in ischemic stroke and traumatic brain injury.

  3. How does environmental regulation impact FORANE’s market?
    Isoflurane has a relatively moderate GWP compared to newer agents like sevoflurane and desflurane. Regulatory policies aiming to reduce high GWP anesthetics may favor isoflurane use, potentially facilitating its market retention.

  4. What factors could hinder FORANE’s market growth?
    Concerns over environmental impact, competition from newer anesthetics with faster onset or lower toxicity, supply chain disruptions, and regulatory delays could impede growth.

  5. Is FORANE gaining market share in emerging markets?
    Yes, affordable cost and established efficacy favor increased usage in middle- and low-income regions, supported by expanding healthcare infrastructure.


Key Takeaways

  • Stable Clinical Portfolio: FORANE maintains widespread use in surgical anesthesia, with ongoing research into neuroprotection.
  • Growing Market Demand: The global anesthetic market is projected to grow at a CAGR of approximately 4.2% through 2030, driven by increasing surgical procedures and technological advances.
  • Regulatory and Environmental Trends: Policies increasingly favor agents with lower environmental impact, benefitting isoflurane’s positioning.
  • Competitive Landscape: Dominated by large pharmaceutical companies, with a trend toward incorporating isoflurane into combination and novel delivery systems.
  • Innovation and Opportunity: Emerging indications like neuroprotection and advanced delivery methods represent growth opportunities; however, environmental and regulatory challenges warrant strategic oversight.

References

[1] ClinicalTrials.gov, "Isoflurane Clinical Trials," 2023.
[2] MarketWatch, "Global Anesthetic Market," 2023.
[3] Environmental Protection Agency, "GWP Data for Inhalation Anesthetics," 2022.
[4] Pharmaceutical Business Review, "Market Trends in Inhalational Anesthetics," 2022.
[5] EMA and FDA regulations, 2023 updates.

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