CLINICAL TRIALS PROFILE FOR FENTANYL-37

505(b)(2) Clinical Trials for Fentanyl-37

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Pfizer	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Duke University	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for Fentanyl-37

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	New York State Psychiatric Institute	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00003000 ↗	Morphine for the Treatment of Pain in Patients With Breast Cancer	Completed	Roswell Park Cancer Institute		1992-05-01	RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Clinical Trial Conditions for Fentanyl-37

Condition Name

Condition Name for Fentanyl-37
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

Condition MeSH for Fentanyl-37
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51
Hypotension	47

Clinical Trial Locations for Fentanyl-37

Trials by Country

Trials by Country for Fentanyl-37
Location	Trials
United States	902
Egypt	361
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for Fentanyl-37
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for Fentanyl-37

Clinical Trial Phase

Clinical Trial Phase for Fentanyl-37
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for Fentanyl-37
Clinical Trial Phase	Trials
Completed	962
Recruiting	315
Unknown status	195

Clinical Trial Sponsors for Fentanyl-37

Sponsor Name

Sponsor Name for Fentanyl-37
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for Fentanyl-37
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Last updated: May 5, 2026

Clinical Trials Update and Market Outlook for FENTANYL-37

No reliable, complete public record ties the designation “FENTANYL-37” to a specific, identifiable fentanyl drug candidate (including sponsor, chemical entity, route, formulation, trial registry identifiers, phase, or regulatory status). Without a determinable mapping from the label “FENTANYL-37” to a real-world development program, any “clinical trials update” or “market analysis and projection” would be non-falsifiable and not suitable for high-stakes decision use.

What clinical trials exist for FENTANYL-37?

No determinable clinical trials can be attributed to “FENTANYL-37” as a uniquely identifiable candidate from standard public trial sources based on the provided label alone.

Trial identifiers that would normally be required for an authoritative update

• ClinicalTrials.gov / EU CTR study records linked to the exact investigational product name
• Sponsor and principal investigator
• Phase (I/II/III), indication, and dosing regimen
• Primary endpoints and data cutoffs
• Status (recruiting, active not recruiting, completed)
• Regulatory designations (Fast Track, Breakthrough Therapy, etc.)

No such linkage can be established from the string “FENTANYL-37” in the absence of an unambiguous program identity.

How big is the market for FENTANYL-37 and what is the projection?

No market sizing or projection can be completed for “FENTANYL-37” because the candidate cannot be uniquely identified (formulation, route, indication, target patient segment, and dosing unit are decisive inputs for TAM/SAM/SOM and adoption modeling).

What must be known to project market share for a fentanyl program

• Route/formulation (e.g., transdermal, oral transmucosal, injectable, sublingual, intranasal)
• Indication (cancer breakthrough pain, chronic pain, perioperative analgesia, opioid substitution, other)
• Dosing unit economics (mg, frequency, pack size, treatment-day cost)
• Competitor set for substitution risk
• Claims and labeling scope tied to the regulatory pathway

The label “FENTANYL-37” does not provide these determinants, so a projection would be arbitrary.

Regulatory and safety context: what changes the outlook for fentanyl development?

A fentanyl candidate’s market path is constrained by the same core regulatory and safety themes that apply to opioid analgesics and controlled substances:

• Controlled-substance scheduling and distribution controls (impacting access and prescriber workflows)
• Risk evaluation and mitigation expectations where applicable
• Abuse-deterrence and misuse risk if the formulation claims address those risks
• Drug-device or formulation-dependent exposure profiles (important for tolerability and switching)

But these factors do not substitute for candidate identity. They cannot be converted into an actionable market forecast for “FENTANYL-37” without knowing which specific product profile the label refers to.

Key Takeaways

• “FENTANYL-37” is not identifiable as a specific fentanyl drug development program from standard public sources based on the provided label alone.
• A clinical trials update cannot be authored without a determinable program mapping (sponsor, trial registry records, phase, and endpoints).
• A market analysis and projection cannot be completed without candidate-defining attributes (route/formulation, indication, dosing unit economics, and the competitive set).

FAQs

1. Can you summarize FENTANYL-37 clinical trial results without trial registry identifiers?
   No; without a uniquely identifiable program, trial attribution is not possible.

2. What inputs drive market projections for fentanyl products?
   Route/formulation, indication, dosing unit economics, labeling scope, and competitor adoption dynamics.

3. Is “fentanyl” market size a proxy for “FENTANYL-37”?
   No; different fentanyl products target different use cases and price points.

4. What makes fentanyl development forecasts high-risk?
   Formulation-dependent exposure and safety profiles, controlled-substance access constraints, and labeling-driven adoption.

5. What would enable an actionable update and forecast for FENTANYL-37?
   A specific, unambiguous mapping to a real-world development program record (trial registry entries and product identity).

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov database. https://clinicaltrials.gov/
[2] European Medicines Agency. EU Clinical Trials Register (EU CTR). https://www.clinicaltrialsregister.eu/
[3] U.S. Food and Drug Administration. Drug Safety and Availability, opioid-related resources. https://www.fda.gov/drugs/drug-safety-and-availability