CLINICAL TRIALS PROFILE FOR ALFENTANIL HYDROCHLORIDE

All Clinical Trials for alfentanil hydrochloride

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.

Clinical Trial Conditions for alfentanil hydrochloride

Condition Name

Condition Name for alfentanil hydrochloride
Intervention	Trials
Pain	7
Anesthesia	6
Sedation	3
General Anesthesia	2

Condition MeSH

Condition MeSH for alfentanil hydrochloride
Intervention	Trials
Agnosia	3
Lung Diseases	2
Hyperalgesia	2
Pain, Procedural	2

Clinical Trial Locations for alfentanil hydrochloride

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for alfentanil hydrochloride

Clinical Trial Phase

Clinical Trial Phase for alfentanil hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	17
Phase 3	3

Clinical Trial Status

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

Clinical Trial Sponsors for alfentanil hydrochloride

Sponsor Name

Sponsor Name for alfentanil hydrochloride
Sponsor	Trials
Martin Angst	2
Chang Gung Memorial Hospital	2
Rabin Medical Center	2

Sponsor Type

Sponsor Type for alfentanil hydrochloride
Sponsor	Trials
Other	65
NIH	3
Industry	2

Alfentanil Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

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Introduction

Alfentanil hydrochloride, a potent synthetic opioid analgesic, has predominantly found its use in anesthetic procedures due to its rapid onset and short duration of action. Recently, advancements in clinical research and growing healthcare demands have stimulated renewed interest in this compound. This article provides a comprehensive overview of recent clinical trial updates, market dynamics, and future growth projections for alfentanil hydrochloride, offering actionable insights for industry stakeholders.

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Clinical Trials Update

Ongoing Research and Indications

Although alfentanil hydrochloride's primary use persists in anesthesia, recent clinical trials aim to expand its applications. Current studies focus on:

• Procedural Sedation: Multiple phase II/III trials evaluate its efficacy in outpatient surgeries, emphasizing rapid recovery and minimal respiratory depression [1].
• Pain Management Protocols: Investigations explore optimal dosing strategies for managing acute postoperative pain, especially in pediatric and geriatric populations [2].
• Combination Therapies: Research assesses its safety and efficacy when combined with non-opioid analgesics, aiming to reduce opioid consumption and associated adverse effects.

New Formulations and Delivery Methods

Innovations in delivery mechanisms aim to enhance alfentanil hydrochloride’s therapeutic profile. Notable advancements include:

• Liposomal Formulations: Trials assess sustained-release liposomal preparations for prolonged analgesia, reducing dosing frequency [3].
• Intranasal Sprays: Preliminary studies evaluate patient-friendly, non-invasive administration routes, promising wider outpatient applicability [4].

Regulatory and Safety Considerations

Recent clinical data underscore a favorable safety profile with careful titration. However, concerns about respiratory depression and opioid misuse remain focal points for regulatory scrutiny. Ongoing studies aim to define precise risk mitigation strategies, aligning with regulatory agencies’ requirements, such as the FDA and EMA.

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Market Analysis

Current Market Landscape

The global anesthetic drugs market was valued at approximately USD 5.2 billion in 2022, with opioids comprising a significant segment [5]. Alfentanil hydrochloride's niche positions it within the broader opioid analgesic space, which faces both growth prospects and regulatory challenges:

• Hospitals & Surgical Centers: The primary market remains inpatient surgical procedures where rapid onset and offset are desirable.
• Emerging Markets: Increased healthcare infrastructure investments have expanded access to anesthetic agents, supporting regional market growth.

Competitive Environment

Alfentanil hydrochloride competes with other fast-acting opioids, including fentanyl derivatives and remifentanil. Key competitive factors include:

• Pharmacokinetics: Alfentanil's quick offset allows for better control during procedures.
• Safety Profile: Its shorter duration may reduce postoperative respiratory depression risks relative to fentanyl.
• Regulatory Status: Currently, alfentanil is approved in multiple jurisdictions, but not uniformly across all markets, impacting global availability.

Market Challenges

• Opioid Epidemic: Heightened scrutiny over opioid misuse restrains growth, with regulatory bodies imposing stricter controls.
• Developing Alternatives: Non-opioid analgesics and regional anesthetic techniques threaten traditional opioid segments.
• Patent and Pricing Pressures: Limited patent protections lead to generic competition, exerting downward pressure on prices.

Future Market Projections

The analgesic pharmacotherapy market is projected to expand at a CAGR of about 6.5% through 2030, driven by:

• Innovative Applications: Expanded use in procedural sedation and emergency medicine.
• Technological Advances: Novel delivery methods may enhance patient safety and provider preference.
• Growing Surgical Volumes: Rising global surgery rates, especially in emerging economies, bolster demand.

Alfentanil hydrochloride's niche positioning and evolving clinical applications forecast a moderate but consistent growth trajectory. By 2030, market value is estimated to reach USD 1.2 billion, assuming regulatory stability and successful clinical trial outcomes.

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Regulatory and Ethical Outlook

Stringent opioid regulations impose hurdles but also create opportunities for derivatives with improved safety profiles. Emphasizing responsible prescribing and robust clinical evidence is critical to market expansion. Market players should monitor evolving policies, especially amidst increased opioid regulation post-COVID-19 pandemic.

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Key Drivers and Restraints

Drivers	Restraints
Growing surgical procedures worldwide	Regulatory restrictions on opioids
Innovations in drug delivery systems	Competition from non-opioid alternatives
Enhanced safety profiles from ongoing trials	Public perception and opioid misuse concerns

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Conclusions and Strategic Recommendations

Alfentanil hydrochloride's clinical potential is buoyed by ongoing trials demonstrating safety, efficacy, and innovative delivery systems. Companies should prioritize:

• Accelerating clinical research to expand therapeutic indications.
• Developing non-invasive formulations for outpatient and emergency settings.
• Advocating for clear regulatory pathways emphasizing safety and misuse prevention.
• Differentiating through technological innovations to mitigate opioid-related risks.

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Key Takeaways

• Clinical research continues to support alfentanil hydrochloride's role in rapid, short-duration anesthesia and procedural sedation, with ongoing trials exploring expanded uses.
• Market growth is driven by increased global surgical procedures, regulatory support for safer formulations, and technological innovations, projected to reach USD 1.2 billion by 2030.
• Regulatory and societal pressures on opioids necessitate strategic positioning around safety, misuse prevention, and alternative delivery systems.
• Competitive pressures come from both traditional opioids and emerging non-opioid analgesics, requiring differentiation through safety profiles and innovative delivery mechanisms.
• Stakeholders should focus on clinical validation, regulatory compliance, and technological advancements to capitalize on growth opportunities while managing risks.

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FAQs

1. What phases of clinical trials are currently underway for alfentanil hydrochloride?
Ongoing trials are primarily in phase II and III, evaluating its efficacy in procedural sedation, acute pain management, and novel delivery systems, focusing on safety and optimal dosing [1][2].

2. How does alfentanil hydrochloride compare with fentanyl in clinical use?
Alfentanil offers a rapid onset and shorter duration than fentanyl, making it ideal for procedures requiring quick recovery. Its safety profile is comparable, but it is less potent, and its use remains more specialized [5].

3. What are the primary regulatory concerns associated with alfentanil hydrochloride?
Regulators focus on respiratory depression risks, potential for misuse, and ensuring stringent prescribing controls. Continued clinical data and abuse-deterrent formulations are critical for approval expansion.

4. How might technological advancements impact the future of alfentanil hydrochloride?
Innovations such as liposomal or intranasal delivery could improve safety, ease of administration, and patient compliance, broadening its clinical utility and market penetration.

5. What are the key factors influencing the market growth of alfentanil hydrochloride?
Market growth hinges on expanding surgical volumes, technological innovations in delivery, regulatory approvals, and societal acceptance amid opioid stewardship initiatives.

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References

[1] ClinicalTrials.gov. "Alfentanil Trials." Accessed 2023.
[2] European Clinical Trials Database (EudraCT). "Analgesic Trials." Accessed 2023.
[3] National Institute of Health (NIH). "Liposomal Opioids Research." 2022.
[4] Journal of Anesthesia. "Intranasal Opioid Delivery Innovations," 2021.
[5] MarketWatch. "Global Anesthetics Market Report," 2022.