CLINICAL TRIALS PROFILE FOR ALFENTANIL

All Clinical Trials for ALFENTANIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001307 ↗	Positron Emission Tomography to Measure Pain and Pain Control	Completed	National Institute of Dental and Craniofacial Research (NIDCR)		1992-08-01	This study will examine how the brain processes pain signals and how the different parts of the brain work with each other in response to painful stimuli. A better understanding of how people experience pain may be helpful in developing more effective treatments. Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and patients with persistent pain due to disease, injury or other reason may be eligible for this study. Participants will receive one or more of the following sensory stimuli, which may cause brief discomfort or pain: - Heat/Cold - applied by an electronically controlled device that touches the skin, or by temperature-controlled water baths, or by a thermally controlled brass cylinder the subject grasps - Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid under the skin or into a muscle - Mechanical stimulation - brushings or vibrations that do not normally cause pain - Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes These stimuli will be applied both before and during positron emission tomography (PET) scanning. This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations. For this procedure, the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions. At the beginning of each scan, radioactive water is injected into an arm vein through a catheter (a thin plastic tube). A special camera records the arrival and disappearance of the radiation in various brain areas, creating a picture of the brain's activity in various regions. Oral surgery patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil, a commonly used narcotic pain reliever, will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer. Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help interpret the PET results. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical machine (the scanner). He or she can speak with a staff member via an intercom system. Some sensory studies may require placing an arterial and/or intravenous line. Following injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular intervals during various sensory stimuli, small blood samples are drawn from the artery to measure blood gases and other substances. Samples may also be drawn from a catheter placed in a vein. Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel. The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel.
NCT00226564 ↗	Genetic Determinants of Opioids Analgesia	Completed	Hadassah Medical Organization	N/A	1997-08-01	The response to opioids varies greatly among individuals. Some of these variability is accounted for by genetic factors. The present study was designed to evaluate the possibility that genetic polymorphism in the gene encoding for mu opioid receptor may explain variability in the response to alfentanil during lithotripsy.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	CareFusion	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	German Federal Ministry of Education and Research	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	Ludwig-Maximilians - University of Munich	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.

Clinical Trial Conditions for ALFENTANIL

Condition Name

Condition Name for ALFENTANIL
Intervention	Trials
Pain	7
Anesthesia	6
Sedation	3
Procedural Pain	2

Condition MeSH

Condition MeSH for ALFENTANIL
Intervention	Trials
Agnosia	3
Hyperalgesia	2
Pain, Procedural	2
Gastrointestinal Diseases	2

Clinical Trial Locations for ALFENTANIL

Trials by Country

Trials by Country for ALFENTANIL
Location	Trials
United States	9
Taiwan	4
Israel	4
China	3
Norway	3

Trials by US State

Trials by US State for ALFENTANIL
Location	Trials
California	2
Maryland	2
Minnesota	2
North Carolina	1
Tennessee	1

Clinical Trial Progress for ALFENTANIL

Clinical Trial Phase

Clinical Trial Phase for ALFENTANIL
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	17
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ALFENTANIL
Clinical Trial Phase	Trials
Completed	35
Unknown status	7
Not yet recruiting	5

Clinical Trial Sponsors for ALFENTANIL

Sponsor Name

Sponsor Name for ALFENTANIL
Sponsor	Trials
Rabin Medical Center	2
Hennepin Healthcare Research Institute	2
Minneapolis Medical Research Foundation	2

Sponsor Type

Sponsor Type for ALFENTANIL
Sponsor	Trials
Other	65
NIH	3
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Alfentanil

Last updated: October 30, 2025

Introduction

Alfentanil, a potent synthetic opioid analgesic, plays an integral role in anesthesia practice due to its rapid onset and short duration of action. Historically utilized during surgical procedures, its pharmacokinetic profile offers advantageous control during anesthesia induction and maintenance. As the landscape of pain management and anesthesia evolves, understanding the current clinical trial activity, market dynamics, and future projections around alfentanil is crucial for stakeholders including pharmaceutical companies, clinicians, and investors.

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Clinical Trials Landscape for Alfentanil

Current State of Clinical Investigations

While alfentanil has been established in clinical use for decades, it remains under active investigation, primarily exploring its applications in specific settings such as emergency procedures, outpatient surgeries, and opioid-sparing anesthesia protocols. The Global Clinical Trials Database reveals a limited but focused number of ongoing studies evaluated within clinical trial registries like ClinicalTrials.gov.

Most recent trials aim to refine administration protocols, assess efficacy and safety in special populations (e.g., pediatric, elderly), and evaluate its role as part of multimodal analgesia strategies. For instance, studies probing rapid recovery in outpatient surgeries or comparing alfentanil with other opioids, such as fentanyl or remifentanil, underscore a persistent research interest. Overall, the trial activity remains modest but steadily consistent with a focus on niche applications rather than broad reintroduction as a primary analgesic.

Major Clinical Findings and Trends

Recent publications point to alfentanil's favorable pharmacological profile, such as reduced histamine release and minimal cardiovascular effects, making it appealing in sensitive patient cohorts. Trials tend to highlight its rapid onset (~1-2 minutes) and short duration (~10-15 minutes), which facilitate precise dosing and quick postoperative recovery.

However, concerns over the opioid epidemic and the potential for respiratory depression continue to factor into trial designs, emphasizing safety assessments. Comparative effectiveness studies suggest that, while effective, alfentanil's use is often subordinate to newer agents offering easier titration and longer duration control, such as remifentanil.

Regulatory and Market Impact

Despite ongoing research directly related to optimized clinical application, alfentanil’s regulatory status remains stable in most jurisdictions. It is primarily available in hospital formulary settings, often compounded or supplied through specialized pharmaceutical intermediaries rather than standalone commercial formulations. A notable trend involves the exploration of generic formulations and biosimilar versions, potentially reducing costs and expanding accessibility.

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Market Analysis of Alfentanil

Historical Market Overview

Historically, the alfentanil market experienced steady demand, driven predominantly by anesthesia providers and hospital purchasing decisions. Its usage was endemic in the 1990s and early 2000s, especially in high-resource healthcare settings like North America and Europe.

Current Market Dynamics

The global opioid market for anesthesia and analgesia currently faces a complex environment shaped by:

• Regulatory Scrutiny: Stringent regulations concerning opioid safety and abuse potential limit widespread adoption.
• Emergence of Alternatives: Agents such as remifentanil, fentanyl patches, and non-opioid analgesics are increasingly favored due to ease of use and safety profiles.
• Operational Considerations: The short half-life of alfentanil, while advantageous in certain contexts, complicates integration into protocols requiring prolonged analgesia.

The market size for alfentanil is now relatively niche, with estimated global revenues in the low hundreds of millions USD as of 2022, significantly below those of mainstream opioids like fentanyl or sufentanil.

Market Drivers and Restraints

Drivers:

• Precision control for rapid surgeries.
• Use in outpatient procedures requiring quick recovery.
• Preference in pediatric and sensitive populations.

Restraints:

• Opioid epidemic impacting prescribing practices.
• Competition from newer opioids with improved safety profiles.
• Rising adoption of multimodal and non-opioid analgesia techniques.

Regional Market Variations

North America remains a key market due to its high surgical volume and advanced anesthetic practices. Europe shows similar trends with institutional preference shifts towards novel agents. Emerging markets in Asia-Pacific exhibit a potential for growth, albeit constrained by regulatory and supply chain complexities.

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Future Market Projections

Forecast Period: 2023–2030

Analysts project a modest growth rate of approximately 2-3% CAGR in the global alfentanil market, driven by niche applications and ongoing research into optimized use. The total market valuation may reach approximately $250-300 million USD by the end of the decade.

Key Growth Opportunities

• Innovative formulations: Developing sustained-release options or combination preparations could extend alfentanil’s utility.
• Specialty use cases: Expansion in pediatric anesthesia, outpatient procedures, and emergency settings.
• Regulatory approvals: Clearer guidelines and label expansions could rejuvenate market interest.

Challenges and Risks

• Increasing regulatory oversight on opioid prescribing.
• Competitive landscape dominated by newer, patent-protected agents.
• Public and institutional shift toward minimizing opioid reliance.

Strategic Considerations for Stakeholders

Stakeholders should monitor evolving clinical evidence, regulatory landscapes, and competitive strategies. Partnerships with research institutions to explore innovative formulations and indications could unlock value. Additionally, engagement with policymakers to address opioid safety concerns might facilitate market access and acceptance.

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Key Takeaways

• Clinical activity remains focused on niche applications, with ongoing investigations into safety, efficacy, and administration optimization.
• Market demand is declining in primary analgesic roles, supplanted by newer agents and multimodal strategies, yet persists in specialized contexts.
• The future outlook is cautious, with slow growth driven by innovation, regulatory shifts, and emerging clinical evidence.
• Opportunities exist for developing novel formulations or expanding indications, especially in outpatient and pediatric anesthesia.
• Stakeholders should prioritize research and regulatory engagement to maintain relevancy amid evolving healthcare policies and opioid use limitations.

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FAQs

1. What is the primary clinical advantage of alfentanil over other opioids?
Alfentanil’s rapid onset and short duration make it suitable for precisely titrated anesthesia during surgeries requiring quick recovery. Its minimal histamine release also reduces cardiovascular risks.

2. Why has alfentanil experienced a decline in widespread use?
The opioid epidemic and safety concerns have restricted opioid prescribing, coupled with the availability of newer agents like remifentanil that offer more convenient pharmacokinetic profiles.

3. Are there ongoing clinical trials testing new applications of alfentanil?
Yes, most studies focus on optimizing dosing protocols, evaluating safety in vulnerable populations, and comparing efficacy with other opioids in specific surgical contexts.

4. What factors could potentially revive alfentanil’s market share?
Development of novel formulations, expanding indications, regulatory approvals, and demonstrated safety advantages in niche settings could bolster its use.

5. How does regional regulation impact alfentanil’s market?
Strict opioid regulations and prescribing restrictions mainly in North America and Europe limit its broader use but may differ regionally, providing opportunities in less restrictive markets.

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References

1. ClinicalTrials.gov for recent studies involving alfentanil.
2. Global Data Reports on the opioid analgesic market, 2022.
3. Pharmacological profiles and safety data from peer-reviewed anesthesia journals.
4. Market intelligence from IQVIA and global pharmaceutical market reports.
5. Regulatory guidelines on opioid use and anesthesia agents from FDA and EMA.

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