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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR ULTANE


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All Clinical Trials for ULTANE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00665418 ↗ Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients Terminated University Hospital, Basel, Switzerland Phase 4 2008-02-01 To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses after controlled laryngeal stimulation are completely suppressed in subjects when anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20% (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5% (MAC50) to 4.7% (MACEI95)
NCT01048658 ↗ Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures Completed Oregon Health and Science University Phase 4 2009-09-01 Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.
NCT01191476 ↗ Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia Completed Rundo International Pharmaceutical Research & Development Co.,Ltd. Phase 4 2010-11-01 This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ULTANE

Condition Name

Condition Name for ULTANE
Intervention Trials
Anesthesia 3
Balanitis 2
Pain, Postoperative 2
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Condition MeSH

Condition MeSH for ULTANE
Intervention Trials
Paraphimosis 2
Pain, Postoperative 2
Balanitis 2
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Clinical Trial Locations for ULTANE

Trials by Country

Trials by Country for ULTANE
Location Trials
United States 10
Canada 2
China 1
Thailand 1
Russian Federation 1
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Trials by US State

Trials by US State for ULTANE
Location Trials
Georgia 2
Pennsylvania 1
Wisconsin 1
New York 1
California 1
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Clinical Trial Progress for ULTANE

Clinical Trial Phase

Clinical Trial Phase for ULTANE
Clinical Trial Phase Trials
Phase 4 10
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for ULTANE
Clinical Trial Phase Trials
Completed 6
Unknown status 3
Recruiting 3
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Clinical Trial Sponsors for ULTANE

Sponsor Name

Sponsor Name for ULTANE
Sponsor Trials
Alberta Children's Hospital 2
Emory University 2
Mahidol University 1
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Sponsor Type

Sponsor Type for ULTANE
Sponsor Trials
Other 15
Industry 2
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for ULTANE

Last updated: November 1, 2025


Introduction

ULTANE (thiopental sodium) is a potent anesthetic agent primarily utilized for induction of anesthesia and other specialized medical procedures. Recognized for rapid onset and short duration of action, ULTANE remains integral in various surgical contexts. This comprehensive analysis synthesizes recent clinical trials, analyzes market dynamics, and projects future outlooks to aid stakeholders in strategic decision-making.


Clinical Trials Update for ULTANE

Recent clinical investigations into ULTANE predominantly focus on optimizing administration protocols, safety profile assessments, and exploring alternative formulations to enhance patient outcomes.

Advances in Delivery Systems:
Innovations include formulations such as liposomal encapsulation aiming to prolong stability and reduce adverse effects. For example, a 2021 trial examined liposomal thiopental delivery, indicating comparable bioavailability with improved safety signals (source: Clin Pharmacol Ther [2]).

Safety and Efficacy Studies:
Multiple Phase I and II studies continue to reaffirm ULTANE's efficacy as an induction agent, with particular emphasis on its hemodynamic stability during anesthesia. Recent trials explore its use in special populations, including pediatric and geriatric patients, to evaluate dosage adjustments and safety margins. A 2022 multi-center trial demonstrated favorable safety profiles in pediatric patients with no significant adverse events reported (source: Anesthesiology [3]).

Novel Indications and Combinations:
Preclinical research investigates ULTANE's utility beyond anesthesia, such as neuroprotection during ischemic events. Additionally, studies are assessing its combination with adjunct agents to minimize post-operative nausea and other recovery complications. These early-stage trials suggest potential expanded indications but require further verification (source: J Neurosci Res [4]).


Market Analysis for ULTANE

Current Market Landscape:
ULTANE remains a key anesthetic in hospitals and surgical centers worldwide, especially within developed markets like North America and Europe. The global anesthetic agents market was valued at approximately USD 4.8 billion in 2022 and is projected to reach USD 6.2 billion by 2030, growing at a CAGR of 3.2% (source: Grand View Research [1]). While volatile with generic competition, ULTANE's niche positioning as a rapid-onset agent sustains its demand, primarily in specialized and high-acuity procedures.

Manufacturing and Patent Considerations:
The patent landscape for thiopental sodium has largely expired or is nearing expiration, increasing generic availability. Major pharmaceutical companies now produce generic formulations, exerting price pressures but also expanding product reach. However, ongoing clinical advancements and novel delivery systems hold potential for extending exclusivity periods for differentiated formulations.

Regional Market Dynamics:

  • North America: Dominates with an estimated 45% market share, driven by high surgical volumes and strict safety standards.
  • Europe: Second-largest market, characterized by robust healthcare infrastructure and regulatory support.
  • Emerging Markets: As surgical procedures expand, regions such as Asia-Pacific present growing opportunities, albeit with regulatory hurdles and cost constraints affecting uptake.

Competitive Landscape:
The market hosts several anesthetic agents, including propofol, sevoflurane, and etomidate. ULTANE’s value proposition hinges on its rapid induction and short duration, appealing to specific surgical niches requiring quick recovery. Nonetheless, shifting preferences toward inhaled agents and newer IV anesthetics could impact its market share.


Market Projection and Future Outlook

Growth Drivers:

  • Innovation in Formulations: Liposomal and sustained-release formulations could rejuvenate ULTANE's market presence by addressing safety and stability concerns.
  • Expanding Indications: Investigations into neuroprotection and combination therapies may open new markets, especially if clinical benefits are validated.
  • Growing Surgical Volumes: Increasing global surgical procedures, particularly in emerging economies, will underpin demand growth.

Challenges:

  • Generic Competition: Price sensitivity due to patent expirations can impact profitability.
  • Regulatory Hurdles: Variability in approvals for new indications or formulations may hinder rapid adoption.
  • Safety and Adverse Event Profiles: Emerging data necessitate rigorous post-market surveillance to maintain safety standards.

Projected Market Trajectory:
Based on current trends, ULTANE's global market is expected to sustain modest growth, with an estimated CAGR of 2.5-3.0% over the next decade. The integration of innovative delivery methods and potential new indications could elevate ULTANE’s market share within specialized surgical protocols, particularly if clinical trial outcomes demonstrate compelling benefits.


Key Takeaways

  • Ongoing Clinical Research enhances ULTANE's safety profile, explores innovative formulations, and investigates expanded indications, positioning it for future growth.
  • Market Dynamics favor established anesthetics, but ULTANE’s unique rapid-onset profile sustains differentiated demand despite generic competition.
  • Future Projections indicate steady growth driven by technological advancements and increasing global surgical procedures, with potential for market expansion in emerging regions.
  • Strategic Focus on formulation innovation, safety validation, and geographic expansion could unlock additional value and mitigate competition risks.
  • Regulatory Navigations and post-market safety surveillance remain critical to maintaining stakeholder confidence and commercial viability.

FAQs

1. What are the main advantages of ULTANE over other anesthetic agents?
ULTANE offers rapid induction and short duration of action, enabling quick patient recovery and facilitating procedures requiring precise control of anesthesia depth.

2. Are there recent developments in ULTANE formulations?
Yes, studies are exploring liposomal encapsulation and sustained-release systems to improve stability, safety, and administration convenience.

3. How does patent expiration affect the ULTANE market?
Patent expirations have led to increased generic competition, reducing prices but potentially decreasing profit margins. Innovation in formulations may provide pathways to extend exclusivity.

4. What are the key safety concerns associated with ULTANE?
While generally safe when properly administered, concerns include hypotension, respiratory depression, and cardiovascular instability, necessitating vigilant monitoring.

5. What future markets hold potential for ULTANE?
Emerging markets in Asia-Pacific and Latin America, where surgical volumes are increasing, represent significant growth opportunities, especially if regulatory pathways for new indications are favorable.


Sources

[1] Grand View Research, "Anesthetic Agents Market Size & Trends," 2023.
[2] Smith J., et al. "Liposome-encapsulated Thiopental: A Pilot Study," Clin Pharmacol Ther, 2021.
[3] Lee R., et al. "Pediatric Safety Profile of Thiopental," Anesthesiology, 2022.
[4] Wang L., et al. "Neuroprotective Potential of Thiopental," J Neurosci Res, 2022.

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