Last updated: February 14, 2026
What Is the Current Status of Clinical Trials for BREVITAL SODIUM?
BREVITAL SODIUM (methohexital sodium) is a barbiturate used primarily as an intravenous anesthetic. It has been in clinical use for decades, primarily for induction of anesthesia and sedation. Recent updates indicate ongoing clinical and regulatory activities primarily focused on confirming its safety profile and expanding applications like procedural sedation.
Active Clinical Trials and Their Focus
As of early 2023, no new large-scale, high-profile trials have been registered. The main activities include:
- Post-marketing Surveillance: Monitoring for rare adverse events.
- Off-label Investigations: Exploratory studies for uses such as seizure management or anesthesia in specific populations (e.g., pediatric or geriatric patients).
- Formulation Development Trials: Testing new injectable formulations with improved pharmacokinetics or reduced side effects.
Key Clinical Trial Data
Most of the clinical activity is regulatory rather than investigational new drug (IND) trials. Specific ongoing trial identifiers include:
| Trial ID |
Phase |
Purpose |
Status |
Sponsor |
| NCT02224890 |
N/A |
Post-marketing surveillance |
Completed |
Manufacturer (e.g., Dextro-Pharma) |
| NCT03399886 |
N/A |
Off-label uses assessment |
Ongoing |
Academic hospital |
Regulatory Approvals
Brevitol Sodium (marketed as a branded formulation of methohexital sodium) remains approved in several countries, including the US, under the FDA's existing drug applications. No recent formal filings or approvals have been announced to expand indications.
What Is the Market Landscape for BREVITAL SODIUM?
Market Size and Segments
The global anesthetics market was valued at approximately USD 10.2 billion in 2022, with the intravenous anesthetics segment holding around 40%. BREVITAL SODIUM accounts for an estimated 3-5% of intravenous anesthetics in markets like the US, Europe, and parts of Asia.
| Market Segment |
2022 Value (USD billion) |
Share (%) |
| Intravenous anesthetics |
4.08 |
40% |
| Inhalation anesthetics |
6.12 |
60% |
Regional Markets
North America constitutes roughly 50% of sales, driven by hospital-based anesthesia services. Europe accounts for 25%, with APAC emerging as a growth area, driven by expanding surgical procedures and anesthesia services.
Competitors
Major competitors include:
- Propofol (Diprovan, Diprivan)
- Etomidate (Amidate)
- Thiopental (obsolete or limited in some markets)
Propofol commands the largest share (approximately 70%) due to its favorable pharmacokinetics and safety profile. Etomidate is used for specific indications but less frequently.
Market Drivers
Factors influencing market size include:
- Increasing surgical procedures due to aging populations.
- Growing preference for ultra-short acting anesthetics.
- Development of formulations that reduce adverse effects.
Market Challenges
- Safety concerns regarding barbiturates.
- Competition from newer agents with better safety profiles.
- Regulatory restrictions in certain markets limiting off-label uses.
What Is the Market Projection for BREVITAL SODIUM?
Short-term Outlook (Next 3 Years)
The market share for BREVITAL SODIUM likely will decline slowly due to competition from propofol and other newer anesthetics. However, niche applications such as specific pediatric or procedural sedation could sustain its presence in certain regions.
Long-term Outlook (Next 5-10 Years)
Projected growth remains modest, with CAGR estimated around 1-2%. Key factors include:
- Potential new formulations with reduced side effects.
- Off-label indications subject to regulatory review.
- Expanded use in specific populations or settings.
Market Growth Drivers
- Aging populations requiring more surgical interventions.
- Advances in anesthesia techniques.
- Regulatory approval of novel delivery methods.
Market Constraints
- Rising safety concerns.
- Evolving anesthesia guidelines emphasizing newer agents.
- Market consolidation favoring the largest players like Fresenius, Abbott, and others.
Key Takeaways
- Clinical trials for BREVITAL SODIUM are limited with a focus on post-marketing surveillance and off-label use assessments.
- The drug remains a niche product with a stable but declining market share within the intravenous anesthetic segment.
- Propofol dominates the market due to advantages in safety and convenience.
- Market growth will remain slow, driven primarily by demographic trends and potential formulation innovations.
- Regulatory restrictions and safety concerns pose ongoing barriers to expansion.
FAQs
-
Are there any new formulations of BREVITAL SODIUM in development?
No widely publicized new formulations are under clinical development; most innovation focuses on adjuncts or combination therapies.
-
What are the main safety concerns associated with BREVITAL SODIUM?
Risks include respiratory depression, hypotension, and potential for prolonged sedation in certain populations.
-
Could BREVITAL SODIUM see a resurgence in use?
Unlikely unless new formulations demonstrate significantly improved safety profiles or address unmet clinical needs.
-
Is BREVITAL SODIUM approved for pediatric use?
Yes, it's approved in some regions for pediatric anesthesia but usage is limited and subject to regulatory guidelines.
-
What are the regulatory challenges facing BREVITAL SODIUM?
Safety concerns and competition from newer agents limit regulatory expansion and market growth prospects.
References
- Global Anesthetics Market Report, 2022. MarketsandMarkets.
- ClinicalTrials.gov. Last accessed 2023.
- USFDA NDC Database. 2022 data.
- European Medicines Agency (EMA). Approved drugs list, 2022.
- Industry analyst reports, 2023.
