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.
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.
NCT00478907 ↗	Prevention of Complications of Eye Surgery	Completed	Isfahan University of Medical Sciences	Phase 2	2004-03-01	This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.

Clinical Trial Conditions for Alfentanil

Condition Name

Condition Name for Alfentanil
Intervention	Trials
Anesthesia	7
Pain	7
Sedation	3
Cancer	2

Condition MeSH

Condition MeSH for Alfentanil
Intervention	Trials
Agnosia	3
Hypoxia	2
Lung Diseases	2
Hyperalgesia	2

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

Trials by US State

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

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

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
Martin Angst	2
Chang Gung Memorial Hospital	2
Rabin Medical Center	2

Sponsor Type

Sponsor Type for Alfentanil
Sponsor	Trials
Other	67
NIH	3
Industry	2

Alfentanil: Clinical Trial Status, Market Signals, and Forward Projections

Last updated: May 1, 2026

What is alfentanil’s current clinical-trials footprint?

Alfentanil is an established, short-acting synthetic opioid approved for perioperative anesthesia. Because it is not a new molecular entity, “clinical trial updates” in the modern period are dominated by (1) pharmacokinetic (PK) studies, (2) dosing and administration route comparisons, and (3) formulation or delivery-system evaluations rather than late-stage phase-3 efficacy programs.

Result: There is no sustained, product-defining global phase-3 pipeline signal attributable to “alfentanil” as a new development theme. The active trial landscape is typically fragmented across small PK and procedural settings, with limited impact on long-horizon market growth.

Clinical-trial activity pattern (practical read-through)

• Primary trial type: PK and administration-method comparisons (e.g., bolus vs infusion, anesthesia adjunct protocols).
• Typical objective: Rapid-onset exposure characterization and recovery timing rather than new indication efficacy.
• Implication for R&D strategy: Trials that change dosing practice can matter for hospital formulary decisions, but they rarely drive broad label expansion.

How does market demand behave for alfentanil?

Alfentanil demand tracks directly to:

1. Procedure volume in settings using general or regional anesthesia with opioid adjuncts.
2. Formulary choice within perioperative pain management.
3. Substitution dynamics versus other IV short-acting opioids (notably fentanyl derivatives and remifentanil depending on region and anesthesia practice).

Competitive substitution map (perioperative setting)

• Nearest functional substitutes: other short-acting IV opioids used for induction, maintenance, and breakthrough perioperative analgesia.
• Clinician workflow factor: onset-offset controllability and titratability under anesthesiology protocols.
• Budget factor: unit acquisition cost plus nursing and monitoring burden.

Demand elasticity

• Low-to-moderate elasticity: alfentanil is a niche-but-established tool where anesthesia teams already standardize workflows.
• Higher elasticity during formulary cycles: switching tends to occur around contract renewal and when evidence-based perioperative pathways are refreshed.

What is the market projection for alfentanil?

Market projections for alfentanil are best treated as a mature, procedure-linked forecast rather than a growth-innovation story.

Directional projection:

• Base case: low single-digit growth, driven by rising surgical volumes offset by generic pressure and substitution within opioid perioperative kits.
• Upside case: faster adoption in specific anesthesia pathways if dosing convenience or protocol fit is validated through clinical evidence that hospitals convert into standardized order sets.
• Downside case: share erosion to alternatives that anesthesiology departments standardize through institutional guidelines.

Projection logic (what moves revenue)

• Volume driver: global and regional growth in inpatient and outpatient surgical procedures.
• Price driver: generic entry and ongoing competitive pricing.
• Mix driver: shift toward alternatives with perceived operational advantages (titration, recovery profile, and protocol fit).
• Policy driver: opioid stewardship policies can tighten prescribing behavior, affecting utilization rates per case rather than stopping use.

Which “clinical trial updates” actually affect commercial outcomes?

In a mature opioid like alfentanil, commercial impact usually comes from trials that translate into:

• Protocol conversion: changes to induction or supplemental bolus standards.
• Administration method adoption: infusion protocols or specific preparation guidance that reduces variability.
• Operational fit: faster titration and predictable recovery that anesthesia departments embed into pathways.

Trial types with the strongest market read-through

• PK and onset-offset characterization under routine perioperative anesthesia conditions.
• Studies that evaluate recovery time endpoints and post-anesthesia readiness.
• Comparative workflow studies that reflect real-world administration patterns.

Market outlook by stakeholder

For pharma and brand owners

• Expect revenue to rely on maintaining formulary positions rather than label-expansion-led growth.
• Focus commercial value on supply reliability, dosing convenience, and contracting in perioperative bundles.

For generic manufacturers

• Growth comes from price competitiveness and distribution coverage.
• Trial activity is useful if it supports protocol adoption that hospitals prefer for standardization.

For health systems

• Alfentanil procurement decisions are driven by:
  • contract pricing,
  • compatibility with anesthesia equipment and preparation workflow,
  • and alignment with opioid stewardship programs.

Patent and lifecycle context (what constrains long-run growth)

Alfentanil is a long-established molecule. The long-run market ceiling is typically determined by:

• prior patent expirations,
• and the resulting genericization and supply competition.

Practical consequence: Even if new clinical work refines dosing, the molecule-level IP barrier is usually not available to create durable exclusivity-led growth.

Key risks to projections

• Share shift to substitutes: anesthesia practice standardization can materially change utilization share.
• Drug safety and stewardship frameworks: policies can reduce per-case use even if surgical volume rises.
• Procurement pressure: hospital contracting can compress prices faster than procedural volumes rise.
• Supply and manufacturing disruptions: mature generics are exposed to supply variability that can cause temporary lost volumes.

Key Takeaways

• Alfentanil’s clinical trial activity is typically PK and administration-focused, with limited evidence of product-defining late-stage development driving new indications.
• Market growth is procedure-linked and maturity-bound: low single-digit growth is the most credible base-case framework, constrained by generic competition and substitution among short-acting perioperative opioids.
• Commercial upside depends on trials that shift anesthesia protocols into standardized order sets; downside risks come from formulary replacement and opioid stewardship-driven reductions in per-case utilization.

FAQs

1) Is alfentanil still seeing new phase-3 development?
No sustained global phase-3 signal is expected for alfentanil as a mature, established opioid; activity is typically focused on PK, dosing regimens, and administration method studies.

2) What most influences alfentanil demand in hospitals?
Procedure volume, perioperative opioid protocol standards, and formulary contracting, with substitution to other short-acting opioids affecting share.

3) Does new clinical evidence tend to expand alfentanil market size?
It can change utilization patterns and protocol adoption, but molecule-level exclusivity is typically constrained; impact is more likely share and mix than broad expansion.

4) How do generic dynamics shape alfentanil revenue?
They compress price and cap molecule-level growth, pushing manufacturers to compete on distribution coverage, reliability, and contracting.

5) What is the biggest downside risk to market projections?
Formulary replacement and opioid stewardship frameworks that reduce per-case opioid exposure, offsetting procedural volume growth.

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References

[1] ClinicalTrials.gov. “Alfentanil” search results. (Accessed 2026-05-01).
[2] FDA. Drug labeling and approvals database. (Alfentanil). (Accessed 2026-05-01).