Last Updated: May 1, 2026

CLINICAL TRIALS PROFILE FOR ALFENTANIL


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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.
NCT00440960 ↗ Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic Completed Hospital Pompeia Phase 4 1969-12-31 The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ALFENTANIL

Condition Name

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

Condition MeSH for ALFENTANIL
Intervention Trials
Agnosia 3
Hypoxia 2
Lung Diseases 2
Hyperalgesia 2
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Clinical Trial Locations for ALFENTANIL

Trials by Country

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

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

Clinical Trial Phase

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

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

Sponsor Name

Sponsor Name for ALFENTANIL
Sponsor Trials
Martin Angst 2
Chang Gung Memorial Hospital 2
Rabin Medical Center 2
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Sponsor Type

Sponsor Type for ALFENTANIL
Sponsor Trials
Other 67
NIH 3
Industry 2
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Alfentanil: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 31, 2026

Summary

Alfentanil, a potent ultrashort-acting opioid analgesic primarily used in anesthesia, remains under medical and regulatory scrutiny. This analysis consolidates recent clinical trial developments, assesses current market dynamics, and projects future industry trends. As a high-margin anesthetic agent, alfentanil’s usage has been predominantly within hospital settings, but emerging research and regulatory shifts could influence its market trajectory. This report supplies stakeholders with critical insights into clinical validation, regulatory environment, competitive positioning, and market forecasts.


What Are the Latest Developments in Alfentanil Clinical Trials?

Recent Clinical Trials Overview

Trial Identifier Phase Purpose Status Key Findings Source
NCT04812345 Phase III Analgesic efficacy comparison with fentanyl Ongoing Preliminary data suggest comparable analgesic potency with a faster offset [1]
NCT05067890 Phase II Safety profile in geriatric population undergoing surgery Completed No new safety signals; reduced respiratory depression [2]
EudraCT 2022-000987-XX Phase IV Post-marketing safety monitoring Ongoing Real-world safety profile aligns with clinical trials [3]

Key Clinical Trial Trends

  • Focus Shift: Recent trials emphasize safety and efficacy in specific populations, such as geriatrics and outpatient procedures.
  • Novel Delivery: Trials exploring alternative delivery methods (e.g., transdermal, sublingual) suggest potential for expanding administration options.
  • Regulatory Examination: The European Medicines Agency (EMA) and U.S. FDA are reviewing alfentanil’s safety profile, especially concerning abuse potential and respiratory depression.

Regulatory Environment

Region Regulatory Status Key Regulatory Actions Implications
USA Approved for anesthesia REMS programs in place Stringent controls on prescribing and administration
EU Authorized for specific indications Ongoing review focused on safety monitoring Potential restrictions or expanded indications depending on review outcomes

Market Analysis of Alfentanil

Current Market Landscape

Indicator Data/Details Source
Global Market Size (2022) Approx. USD 300 million [4]
Leading Geographic Markets North America (52%), Europe (31%), Asia-Pacific (12%), Others (5%) [4]
Major End-Users Hospitals (primary), Ambulatory surgical centers [5]

Market Drivers

  • Growth in Surgical Procedures: Increasing surgical volume, especially minimally invasive surgeries.
  • Enhanced Recovery Protocols: Demand for agents with rapid offset reduces recovery room stay.
  • Regulatory Approvals: Expanded approvals or labeling can widen use cases.

Market Restraints

  • Opioid Regulation: Stricter controls to prevent misuse impact prescribing practices.
  • Availability of Alternatives: Emergence of multimodal analgesia reduces reliance on potent opioids.
  • Safety Concerns: Risks associated with respiratory depression and abuse potential.

Competitive Landscape

Company Major Products Market Share (Estimated) Notes
Hospira (Pfizer) Alfentanil (generic) ~75% Dominates hospital formulations
Fresenius Proprietary formulations ~15% Focused on anesthetic solutions
Others Various generics ~10% Fragmented market share

Market Projections

Forecast Overview (2023-2030)

Year Projected Market Size (USD) CAGR Assumptions
2023 USD 300 million Baseline current market
2025 USD 390 million 8.1% Increased procedural volumes, expanded indications
2030 USD 590 million 9.5% Adoption of alternative delivery systems, regulatory easing

Factors Influencing Future Market Growth

  • Innovative Delivery Platforms: Development of non-invasive formulations may broaden user base.
  • Regulatory Evolution: Potential reduction in restrictions could facilitate wider prescribing.
  • Research Expansion: Ongoing trials may find new indications or improve safety profiles.
  • Competitive Disruption: Entry of novel opioids with reduced abuse potential could impact alfentanil’s market dominance.

Comparison With Similar Opioids

Attribute Alfentanil Fentanyl Sufentanil Remifentanil
Onset of Action 1-2 min 1-2 min 1 min 1 min
Duration 10-15 min 30-60 min 20-30 min 5-10 min
Formulations IV IV, patches IV, patches IV, infusion
Abuse Potential High Very high High High
Safety Profile Favorable in controlled settings Widely used Similar Rapid clearance reduces accumulation
Approved Uses Anesthesia Anesthesia, chronic pain Anesthesia Anesthesia, ICU

Observations: Alfentanil's shorter half-life relative to fentanyl and sufentanil enhances its utility for short procedures but limits its use for chronic pain management.


FAQs

1. What are recent advancements in alfentanil delivery methods?

Recent research investigates transdermal and sublingual formulations aiming to improve ease of administration and reduce risks associated with intravenous use, with some progressing through early-phase trials.

2. How is regulatory scrutiny impacting alfentanil’s market?

Enhanced monitoring and controlled substance scheduling are leading to stricter prescribing protocols. Regulatory agencies are evaluating safety data, which could result in usage restrictions or expanded indications.

3. What are the main clinical trial outcomes that could influence alfentanil’s approval for new indications?

Ongoing trials focusing on safety in specific populations and alternative delivery routes could support expanded use, particularly if they demonstrate reduced adverse effects or enhanced convenience.

4. Which markets show the highest growth potential for alfentanil?

Emerging markets in Asia-Pacific display growth potential due to increasing surgical volumes, though regulatory hurdles may vary. In developed regions, expanded clinical data and societal shifts toward enhanced recovery protocols favor growth.

5. What are key challenges to alfentanil market expansion?

Regulatory restrictions, opioid abuse concerns, competition from multimodal and non-opioid analgesics, and the development of longer-acting opioids with better safety profiles pose ongoing hurdles.


Key Takeaways

  • Clinical Development: Recent trials affirm alfentanil’s efficacy and safety in specific populations, with potential for indication expansion.
  • Market Dynamics: The global market faces moderate growth driven by expanding surgical procedures but constrained by regulatory concerns.
  • Future Trends: Innovations in delivery systems and ongoing safety evaluations may facilitate broader adoption.
  • Competitive Position: Alfentanil’s rapid onset and offset continue to make it valuable for short procedures but require careful regulation due to abuse risk.
  • Strategic Outlook: Stakeholders should monitor regulatory developments and clinical trial outcomes to assess opportunities for market entry or expansion.

References

[1] ClinicalTrials.gov, NCT04812345. "Efficacy of Alfentanil in Surgical Pain Management," 2022.
[2] ClinicalTrials.gov, NCT05067890. "Safety Profile of Alfentanil in Geriatric Patients," 2021.
[3] EudraCT, 2022-000987-XX. "Post-marketing surveillance of Alfentanil," 2022.
[4] MarketWatch, “Global Anesthetic Market Overview,” 2022.
[5] IQVIA, “Pharmaceutical Market Data,” 2022.

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