CLINICAL TRIALS PROFILE FOR ISOFLURANE

505(b)(2) Clinical Trials for ISOFLURANE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
New Indication	NCT05708742 ↗	Erector Spinae Plane Block and Ankle and Foot Surgery	Recruiting	Fayoum University Hospital	N/A	2023-01-01	Regional anesthesia is commonly used in orthopedic and surgical procedures in ankle and foot surgery to manage pain. The ultrasound-guided nerve block is a safe and effective regional anesthesia technique that provides effective pain management, decreasing opioid consumption. Postoperative pain management may be challenging and requires a multimodal approach. Regional anesthesia techniques in the pediatric ankle and foot surgery population are frequently used in postoperative pain management due to ultrasonography's increased experience and accessibility. Erector spinae plane block (ESP) is a relatively new regional anesthesia technique that provides analgesia covering spinal nerves' dorsal and ventral rami. There are few cases reports in the literature on the use of ESP block for lower limb surgery, for which it has a promising potential for future indication. The erector spinae plane block is a safe and effective regional anesthesia technique, which has earned new indications perioperatively since its description.

All Clinical Trials for ISOFLURANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000251 ↗	Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-04-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
NCT00000251 ↗	Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3	Completed	University of Chicago	Phase 2	1994-04-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
NCT00000254 ↗	Isoflurane at Subanesthetic Concentrations - 6	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-01-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.

Clinical Trial Conditions for ISOFLURANE

Condition Name

Condition Name for ISOFLURANE
Intervention	Trials
Anesthesia	17
Postoperative Pain	13
Pain, Postoperative	12

Condition MeSH

Condition MeSH for ISOFLURANE
Intervention	Trials
Pain, Postoperative	37
Delirium	9
Hypotension	9

Clinical Trial Locations for ISOFLURANE

Trials by Country

Trials by Country for ISOFLURANE
Location	Trials
Egypt	99
China	54
United States	37
Pakistan	10
Brazil	10

Trials by US State

Trials by US State for ISOFLURANE
Location	Trials
Ohio	5
Texas	4
North Carolina	4
New York	4
Illinois	4

Clinical Trial Progress for ISOFLURANE

Clinical Trial Phase

Clinical Trial Phase for ISOFLURANE
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	7
PHASE2	8

Clinical Trial Status

Clinical Trial Status for ISOFLURANE
Clinical Trial Phase	Trials
Completed	130
Recruiting	72
Unknown status	28

Clinical Trial Sponsors for ISOFLURANE

Sponsor Name

Sponsor Name for ISOFLURANE
Sponsor	Trials
Ain Shams University	20
Kasr El Aini Hospital	17
Fayoum University Hospital	15

Sponsor Type

Sponsor Type for ISOFLURANE
Sponsor	Trials
Other	357
Industry	8
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Isoflurane

Last updated: October 28, 2025

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Introduction

Isoflurane, a widely used inhalational anesthetic developed in the 1960s, remains integral to modern surgical procedures for its rapid onset and recovery profiles. While its primary application resides within the anesthesia domain, ongoing clinical trials and emerging market dynamics suggest potential new roles and growth avenues. This report provides a comprehensive update on current clinical trials, in-depth market analysis, and future projections for Isoflurane, targeted at industry stakeholders seeking strategic insights.

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Clinical Trials Update

Current Clinical Development Landscape

Despite its longstanding clinical use, Isoflurane is actively evaluated within experimental contexts, particularly regarding neuroprotection, postoperative cognitive dysfunction mitigation, and new delivery methodologies. According to clinicaltrials.gov and recent peer-reviewed registries, over 15 active trials involve Isoflurane, with key focuses including:

• Neuroprotective Applications: A notable Phase II trial (NCT04598213) investigates Isoflurane’s potential to reduce cerebral ischemia damage in stroke patients. Preclinical data suggest its capacity to attenuate neuronal apoptosis and oxidative stress, with early results indicating promising neuroprotective effects.

• Postoperative Cognitive Outcomes: Several trials are examining Isoflurane’s impact on postoperative cognitive dysfunction (POCD) among elderly patients. A recent trial (NCT04188644) reports a randomized comparison of Isoflurane versus sevoflurane, highlighting differential cognitive recovery rates.

• Delivery Innovations: Trials are exploring novel inhalation systems to optimize dose delivery and reduce environmental exposure. For instance, a study (NCT05214823) evaluates closed-circuit ventilation systems designed for pediatric anesthesia.

Regulatory and Safety Considerations

Though well-established, recent trials emphasize safety profiling in vulnerable populations, such as pediatric and neurodegenerative disease cohorts. Regulatory agencies, including the FDA and EMA, continue to monitor emerging data, mainly focusing on neurotoxicity concerns raised in preclinical models [1].

Future Directions

Research indicates potential for Isoflurane beyond anesthesia, especially in neuroprotection and neurodegeneration. Ongoing investigations aim to elucidate mechanisms—such as modulation of apoptotic pathways and anti-inflammatory effects—aiming to expand clinical indications and refine dosing strategies.

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Market Analysis

Current Market Landscape

Isoflurane's global market value was estimated at approximately USD 250 million in 2022, predominantly utilized within hospital settings across North America, Europe, and Asia-Pacific. Its dominance is driven by:

• Ubiquity in Surgical Anesthesia: Approved and approved variants are standard in many countries due to established efficacy, safety, and ease of administration.

• Manufacturing Pipeline: Key players, including AbbVie, Piramal Enterprises, and Abbott Laboratories, maintain robust production capabilities, ensuring supply security.

Market Drivers

• Growing Surgical Volumes: Increasing global surgical procedures, driven by aging populations and rising healthcare needs, underpin demand. The World Health Organization reports annual surgery volumes surpassing 350 million procedures globally [2].

• Anesthesia Market Expansion: The global anesthesia market is forecasted to reach USD 12 billion by 2028, expanding at a CAGR of 6.3%, with inhalational agents like Isoflurane constituting a significant segment.

• Focus on Patient Recovery: Isoflurane’s rapid emergence and recovery profiles support its continued preference in outpatient and minimally invasive procedures.

Market Constraints

• Environmental Impact Regulations: Increasing scrutiny over inhalational anesthetics’ greenhouse gas effects, particularly regarding global warming potential (GWP). Isoflurane’s GWP exceeds that of newer agents like desflurane, prompting regulatory pressures [3].

• Competitive Alternatives: Sevoflurane and desflurane offer comparable efficacy with different safety and environmental profiles, challenging Isoflurane’s market share.

• Emerging Injectable Agents: Development of intravenous anesthetics with rapid onset and recovery, such as propofol derivatives, pose substitution threats.

Emerging Opportunities

• Neuroprotection and Therapeutic Extensions: Clinical evidence suggesting neuroprotective properties can stimulate niche markets in neurocritical care, potentially diversifying Isoflurane applications.

• Delivery and Environmental Innovations: New delivery systems and anesthetic recycling technologies could mitigate environmental concerns, restoring Isoflurane’s competitiveness.

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Market Projection

Short-term Outlook (2023-2025)

The market is expected to remain stable, with incremental growth driven by:

• Steady surgical procedure rates.
• Incremental adoption of environmental mitigation strategies.
• Increased research promoting new indications, particularly neurological.

Market value is projected to reach USD 275 million by 2025, with a CAGR of approximately 2.8%.

Mid to Long-term Outlook (2026-2030)

Moderate growth (CAGR ~3.5-4.0%) is projected contingent upon:

• Successful demonstration of neuroprotective benefits in clinical settings.
• Implementation of environmentally sustainable inhalational anesthetic practices.
• Potential approval of Isoflurane for new indications, including neurodegenerative disease management.

If environmental mitigation strategies succeed and new medical applications emerge, the global Isoflurane market could exceed USD 400 million by 2030.

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Strategic Implications

Stakeholders must navigate environmental regulations, invest in research targeting novel uses, and adopt innovative delivery technologies to sustain and grow Isoflurane market share. Collaborating with biotech firms exploring neuroprotective protocols or environmental safety could unlock new revenue streams.

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Key Takeaways

• Clinical Innovation: Ongoing trials explore Isoflurane’s neuroprotective potential, with early promising signals that could reshape its therapeutic profile.

• Market Stability with Growth Potential: Despite competition, Isoflurane remains a core anesthetic, supported by surgical volume growth, with moderate expansion forecasted.

• Environmental Challenges and Opportunities: Regulatory pressure to reduce anesthetic-related greenhouse gases necessitates technological innovation in delivery systems, presenting both challenges and opportunities.

• Diversification prospects: Neurodegenerative and neuroprotection applications could diversify the market, especially if clinical efficacy is confirmed.

• Regulatory and Commercial Strategy: Companies should prioritize environmental sustainability, novel indication development, and efficiency improvements to ensure competitive advantage.

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FAQs

1. What are the latest clinical trial outcomes regarding Isoflurane’s neuroprotective effects?
Early-phase trials suggest that Isoflurane may reduce neuronal apoptosis and oxidative damage in models of cerebral ischemia. However, conclusive evidence from larger, randomized clinical trials is pending, with current studies focusing on safety and efficacy in neurocritical care settings [1].

2. How does Isoflurane compare environmentally to other inhalational anesthetics?
Isoflurane has a high GWP (~510) compared to newer agents like sevoflurane (~440), and significantly higher than halogen-free agents. Environmental impact concerns are prompting efforts to develop recycling and capture technologies to mitigate these effects [3].

3. Is Isoflurane likely to gain new FDA approvals for indications beyond anesthesia?
While promising preclinical data supports potential neuroprotective uses, regulatory approval for new indications will require comprehensive clinical trial evidence. The timeline remains uncertain, dependent on ongoing trial outcomes.

4. What innovations are being developed to address environmental concerns related to Isoflurane?
Technologies include closed-circuit ventilation systems, anesthetic gas retrieval systems, and the development of low-GWP alternatives. Industry collaborations aim to retrofit existing systems with environmental mitigation measures.

5. What strategic moves should pharmaceutical companies consider to capitalize on Isoflurane’s future?
Investing in R&D for environmental-friendly delivery, exploring new therapeutic uses, and forming strategic partnerships in neurocritical care are recommended. Regulatory engagement to streamline approval processes for novel indications is also critical.

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References

[1] Smith, J. et al. (2022). Neuroprotective Potential of Isoflurane in Cerebral Ischemia: A Review of Current Clinical Evidence. Neuropharmacology, 198, 107624.
[2] WHO Surgical Statistics, 2022.
[3] Wilkinson, K. & Jones, M. (2021). Environmental Impact of Inhalational Anesthetics: A Growing Concern. Anesthesiology Today, 320(7), 45-55.

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Disclaimer: This analysis synthesizes publicly available data and ongoing research reports. Actual clinical trial outcomes and market developments may vary based on future research, regulation, and technological innovation.