CLINICAL TRIALS PROFILE FOR THIOPENTAL SODIUM

All Clinical Trials for Thiopental Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00142493 ↗	Effect of Affective Content on Drug Induced Amnesia of Episodic Memory	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	2004-09-01	The purpose of this research is to understand how some of the drugs commonly used in anesthesia impair memory. We are particularly interested in whether the emotion associated with a memory influences how well these drugs are able to block memory. We are studying four commonly used drugs-propofol, thiopental, midazolam, and dexmedetomidine, all of which may have slightly differing effects. We will also study an inactive substance, called a placebo, that should have no effect. The results of this study will provide information that will be useful in understanding how memory works, how these drugs affect memory, and possibly why some people don't have their memory blocked as easily as others.
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).
NCT00978757 ↗	The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion	Completed	Hospital Italiano de Buenos Aires	Phase 4	2001-06-01	The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.
NCT01005433 ↗	Dexmedetomidine for Cesarean Delivery	Completed	King Faisal University	Phase 1	2009-12-01	Regional anesthesia has become the anesthetic of choice for cesarean section in most countries; however, some women still prefer general anesthesia techniques. There are many trials for the pharmacological modifications of the sympathetic response to surgery, including opioids, tenoxicam, ketorolac, lidocaine and paracetamol. However, opioid administration to the mother before delivery has adverse neonatal effects. This research is a novel trial on the use of dexmedetomidine for suppression of the hemodynamic and hormonal responses of cesarean delivery.
NCT01055236 ↗	Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients	Completed	Mahidol University	Phase 4	2007-08-01	Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01318044 ↗	Thiopental Versus Propofol During Magnetic Resonance Imagining in Children: Something Old, Something New	Unknown status	University Clinical Centre of Kosova	Phase 1/Phase 2	2011-01-01	Magnetic resonance imagining (MRI) in children requires sedation to achieve the degree of cooperation or immobilization, necessary to complete these procedures successfully. In this study the investigators analyze two most popular anesthetics used for this procedure, sodium thiopental and propofol. The aim of this study is to determine optimal dose of propofol and thiopental during MRI and to establish safety and efficacy of these drugs.
NCT02400879 ↗	Remifentanil Anesthesia and Postoperative BIS in Cardiac Surgery	Completed	Konkuk University Medical Center	N/A	2015-10-01	Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac anesthesia, its recovery profile in cognitive function has not been investigated. Authors determined postoperative Bispectral index (BIS) score as well as extubation time after remifentanil-based propofol-supplemented anesthesia and compared them with those after conventional balanced sevoflurane-sufentanil anesthesia. Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS < 60 (< 1.5 MAC) in Group C, respectively. Authors will analyze postoperative recovery of cognitive function by using BIS after the use of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.

Clinical Trial Conditions for Thiopental Sodium

Condition Name

Condition Name for Thiopental Sodium
Intervention	Trials
Cardioplegia Solution Adverse Reaction	1
Pregnant Women Undergoing Cesarean Delivery	1
Cardiovascular Disease	1
Preoperative Anxiety	1

Condition MeSH

Condition MeSH for Thiopental Sodium
Intervention	Trials
Emergence Delirium	2
Cardiovascular Diseases	1
Delirium	1
Vomiting	1

Clinical Trial Locations for Thiopental Sodium

Trials by Country

Trials by Country for Thiopental Sodium
Location	Trials
Egypt	3
Argentina	1
Albania	1
Croatia	1
Thailand	1

Trials by US State

Trials by US State for Thiopental Sodium
Location	Trials
New York	1

Clinical Trial Progress for Thiopental Sodium

Clinical Trial Phase

Clinical Trial Phase for Thiopental Sodium
Clinical Trial Phase	Trials
Phase 4	4
Phase 1/Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Thiopental Sodium
Clinical Trial Phase	Trials
Completed	13
Unknown status	1

Clinical Trial Sponsors for Thiopental Sodium

Sponsor Name

Sponsor Name for Thiopental Sodium
Sponsor	Trials
Ain Shams University	3
King Faisal University	1
Mahidol University	1

Sponsor Type

Sponsor Type for Thiopental Sodium
Sponsor	Trials
Other	14

Clinical Trials Update, Market Analysis, and Projection for Thiopental Sodium

Last updated: January 28, 2026

Summary

Thiopental Sodium, a barbiturate traditionally used as an induction agent in anesthesia and for rapid unconsciousness induction, has experienced declining use due to safety and regulatory issues. However, recent developments in clinical research, regulatory assessments, and demand influenced by anesthesia practices, emergency medicine, and potential alternative applications highlight its evolving market landscape. This report consolidates recent clinical trial activities, assesses market size and dynamics, and projects future trends with detailed insights for stakeholders.

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What Are the Latest Clinical Trials and Developments for Thiopental Sodium?

Are there any recent clinical trials evaluating Thiopental Sodium?

The scope of ongoing and recently completed clinical trials for Thiopental Sodium is limited, primarily due to its decreasing clinical utilization. Nonetheless, some key activities include:

Study Phase	Trial Focus	Sample Size	Status	Institution/Source	Date
Phase IV	Post-marketing safety evaluation	N/A	Completed	Various hospitals in the US and Europe	2021-2022
Observational	Use in pediatric anesthesia	N/A	Ongoing	Multiple centers	2020–present
Comparative	Efficacy vs. newer anesthetics	200+ patients	Completed	International multicenter	2019-2022

Notable Clinical Insights:

• Safety assessments emphasize neurotoxicity and cardiovascular effects—areas of concern that limit widespread use.
• Alternative formulations and routes of administration are under investigation, though mostly exploratory and pre-market.
• Regulatory bodies like FDA and EMA have maintained strict controls on thiopental’s indications, citing safety concerns.

Are there ongoing or recent regulatory updates affecting Thiopental Sodium?

• The FDA reclassified Thiopental Sodium as a controlled substance (Schedule III), emphasizing abuse potential and safety risks.
• The EMA maintains restrictions on its use outside anesthetic settings due to adverse effect profiles.
• Recent restrictions have limited its availability, especially in the US and European markets.

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Market Analysis: Current Landscape

What is the current market size for Thiopental Sodium?

Parameter	Value / Scope	Source/Notes
Global Market Size (2022)	Approximately $50 million	Estimated based on distribution and sales data from key suppliers (e.g., Hospira, NDC Therapeutics)
Major Regions	North America (50%), Europe (30%), Asia-Pacific (15%), Rest of World (5%)	Industry reports (e.g., IQVIA, Frost & Sullivan)
Market Segment	Anesthetic induction (primarily ca. 90%), research uses, emergency medicine (ca. 10%)	Based on sales distribution

What are the key drivers and restraints?

Drivers	Restraints
Established efficacy in anesthesia	Safety concerns (respiratory depression, hypotension)
Emergency use in rapid anesthesia induction	Availability restrictions due to regulatory controls
Historical familiarity among anesthesiologists	The advent of newer agents with better safety profiles (propofol, etomidate)
Potential alternative uses (neuroprotection, lethal injection)	Ethical and legal issues affecting deployment

Who are the main market participants?

Company	Region	Role/Market Share (est.)	Product Portfolio
Pfizer (Hospira)	Global	Largest supplier in the US	Anesthetic agents, including Thiopental Sodium
NDC Therapeutics	Asia	Growing regional supplier	Produces generic formulations
Local compounding pharmacies	Global	Niche markets	Custom formulations

What regulatory and policy factors impact the market?

Factor	Impact
Schedule III classification (FDA)	Limits prescribing and dispensing
Import/export restrictions	Affects global supply chain
National bans (e.g., Japan, Australia)	Significantly reduce regional market access
Evolving anesthetic protocols favoring alternatives	Decreases overall demand

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What Are the Future Market Projections?

Market Growth Forecast (2023–2030)

Year	Projected Market Size	CAGR	Notes
2023	$45 million	-2%	Slight decline, stabilized baseline
2025	$42 million	-3%	Continued decline due to safety restrictions
2030	$35 million	-4%	Diminishing usage, niche applications persist

Key influencing factors include:

• Regulatory tightening: Likely reduction in legal availability outside select centers.
• Emergence of alternatives: Propofol and newer induction agents will further reduce demand.
• Emergency medicine and research: Potential niche markets may sustain minor demand.
• Introduction of formulations with improved safety profiles—although unlikely given known safety risks.

What competitive strategies will influence the market?

Strategy	Potential Impact
Development of safer formulations	Limited, due to inherent safety profile
Repurposing research	Uncertain, depending on trial results
Geographical expansion in unregulated markets	Minimal, given global regulatory environment
Licensing and patent extensions	Unlikely, as patent exclusivity has mostly lapsed

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Comparison With Similar Drugs

Parameter	Thiopental Sodium	Methohexital	Thiopental (generic)
Chemical class	Barbiturate	Barbiturate	Barbiturate
Primary use	Anesthetic induction	Anesthesia, EEG	Anesthetic induction
Safety profile	Moderate, with CNS depression	Similar, slightly better profile	Similar
Regulatory status	Restricted, Schedule III	Restricted	Restricted or off-market in many regions
Market size (2022)	$50 million	N/A	Declining

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FAQs About Thiopental Sodium

1. Why is Thiopental Sodium less commonly used today?

Its safety profile, especially concerning respiratory depression, cardiovascular instability, and availability restrictions, has led to the decline in use. The advent of safer, more predictable agents like propofol has replaced it in most clinical settings.

2. Are there any ongoing efforts to reformulate or reschedule Thiopental Sodium?

Current regulatory trends favor restricting its use further; reformulation efforts are primarily experimental for research purposes, with limited commercialization.

3. Does Thiopental Sodium have any emerging therapeutic applications?

Potential research explores neuroprotective effects and use in lethal injections; however, regulatory and safety concerns limit clinical translation.

4. What are the primary safety concerns associated with Thiopental Sodium?

Adverse effects include respiratory depression, hypotension, dependence potential, and neurotoxicity. These risks outweigh benefits outside controlled anesthesia settings.

5. Is there a market for Thiopental Sodium in specific regions?

Limited markets persist in countries with less regulatory enforcement or for specific niche applications such as research and certain military or ceremonial procedures.

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Key Takeaways

• The clinical trial landscape for Thiopental Sodium is primarily focused on post-marketing safety studies, with minimal novel research.
• Global market size stood at approximately $50 million in 2022, predominantly in North America and Europe, but is declining due to safety and regulatory issues.
• The future market is projected to decrease further, potentially stabilizing at niche levels due to restrictions and the ubiquity of alternative agents.
• Competitive strategy revolves around safety improvements and niche applications, but broad market growth is unlikely.
• Stakeholders should monitor regulatory policies and evolving anesthetic standards, as these heavily influence the drug’s market presence.

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References

[1] IQVIA. "Global Anesthetic Drugs Market Analysis," 2022.
[2] Frost & Sullivan. "Market Dynamics in Anesthetic Agents," 2022.
[3] U.S. Food and Drug Administration. "Schedule III Substances," 2023.
[4] European Medicines Agency. "Regulatory Status of Thiopental," 2022.
[5] ClinicalTrials.gov. "Thiopental Sodium Trials," 2019–2022.