CLINICAL TRIALS PROFILE FOR FENTANYL HYDROCHLORIDE

505(b)(2) Clinical Trials for FENTANYL HYDROCHLORIDE

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).
New Formulation	NCT01717157 ↗	A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers	Completed	Janssen Research & Development, LLC	Phase 1	2012-08-01	The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.
New Formulation	NCT02608320 ↗	A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Hea	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-17	The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.

All Clinical Trials for FENTANYL HYDROCHLORIDE

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.
NCT00027014 ↗	Herb-Opioid Interactions	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-09-01	This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
NCT00095251 ↗	MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status	Completed	Vanderbilt University	Phase 2	2004-08-01	Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).

Clinical Trial Conditions for FENTANYL HYDROCHLORIDE

Condition Name

Condition Name for FENTANYL HYDROCHLORIDE
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

Condition MeSH for FENTANYL HYDROCHLORIDE
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51
Hypotension	47

Clinical Trial Locations for FENTANYL HYDROCHLORIDE

Trials by Country

Trials by Country for FENTANYL HYDROCHLORIDE
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 HYDROCHLORIDE
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for FENTANYL HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	962
RECRUITING	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL HYDROCHLORIDE

Sponsor Name

Sponsor Name for FENTANYL HYDROCHLORIDE
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for FENTANYL HYDROCHLORIDE
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Fentanyl Hydrochloride: Clinical-Trial Update, Market Analysis, and Revenue Projection

Last updated: April 27, 2026

What is the current clinical-trial status for fentanyl hydrochloride?

Fentanyl hydrochloride is an established opioid analgesic with multiple approved formulations and ongoing studies concentrated in two areas: (1) new drug delivery systems and route refinements that aim to improve onset, duration, or misuse-resistance; and (2) safety and efficacy in specific patient populations and settings (perioperative pain, cancer-related breakthrough pain, opioid dependence treatment-related co-therapies, and pediatrics).

Operational constraint: Producing a complete, accurate, trial-level “update” for fentanyl hydrochloride requires a current, molecule-specific trial registry pull (e.g., ClinicalTrials.gov NCT list with status and endpoints). Without registry access in this response, a trial-by-trial update would risk factual errors.

Result: No clinical-trial update can be issued under the requirement for complete and accurate information.

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How big is the fentanyl hydrochloride market today?

Market definition

For market sizing, “fentanyl hydrochloride” should be treated as the active drug substance basis for:

• Prescription fentanyl products (many are salts; fentanyl hydrochloride is the common reference form).
• Medical fentanyl use across oncology breakthrough cancer pain, perioperative anesthesia and analgesia, and pain management pathways.

Because market datasets vary by whether they include only prescription sales, include transdermal-only, or include all fentanyl products (including off-label or illicit spillover), a single authoritative figure cannot be produced reliably without a defined vendor methodology and a cited dataset extract.

What can be stated with certainty from public sources

Fentanyl is a controlled opioid with a wide clinical footprint and broad regulatory oversight. Multiple jurisdictions run supply controls, diversion controls, and prescribing programs due to overdose risk.

Result: No defensible numeric market size, share, or segment split can be stated here without a cited sales dataset and a defined methodology.

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What revenue projection is supportable for fentanyl hydrochloride?

Projection framework that fits an approved drug substance

Revenue projection for an established molecule depends on:

• Product lifecycle (patent expiry landscape at product level, not drug substance).
• Formulation competition (generic entry for specific routes and strengths; brand differentiation for delivery systems).
• Regulatory and payer pressure (prior authorization, opioid stewardship programs, risk mitigation REMS where applicable).
• Utilization controls tied to opioid-safety campaigns.

But fentanyl hydrochloride is not traded as a single “brand.” Revenue is realized at formulation/product level (for example, transdermal patches versus oral transmucosal systems versus injectable fentanyl products). Converting to a single projection for “fentanyl hydrochloride” requires mapping from product-level revenues back to the salt basis, which is not possible to do accurately without product-specific sales data and a salt-to-product conversion policy.

Result: A complete and accurate numeric revenue projection cannot be issued.

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Where do opportunities and risks concentrate in fentanyl hydrochloride development?

Even without trial-by-trial updates or numeric revenue, business-relevant development implications are consistent:

Development opportunity lanes

• Route and delivery improvement: faster titration, steadier pharmacokinetics, and patient usability enhancements.
• Abuse-deterrent / misuse-resistance strategies: design changes that reduce tampering or rapid-release extraction.
• Population focus: perioperative analgesia protocols, pediatric dosing regimens where approved, and cancer-related breakthrough pain workflows.

Risk vectors

• Classwide opioid safety scrutiny: overdose risk, diversion, and prescribing restrictions.
• Formulation-level patent and exclusivity cliffs: competitors may launch generics for specific delivery systems rather than the salt itself.
• Manufacturing and supply controls: controlled-substance logistics and regulatory compliance cost.

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Key business implications for R&D and investment

1) Competitive edge is formulation, not the molecule

Fentanyl hydrochloride’s chemical entity is established. Commercial differentiation comes from:

• delivery system performance (onset, duration, reliability),
• usability and patient adherence,
• risk mitigation characteristics.

2) Claims must tie to clinical endpoints

Regulators and payers increasingly demand evidence tied to:

• safety outcomes,
• meaningful reductions in inappropriate use,
• consistent analgesic outcomes under real-world use conditions.

3) Timeline planning should follow formulation patent reality

A “fentanyl hydrochloride” strategy must be mapped to:

• each product’s patent estate,
• exclusivities and regulatory exclusivity (where applicable),
• generic launch risk for the route and strength portfolio.

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Key Takeaways

• A complete, accurate clinical-trial update with trial status, endpoints, and timelines cannot be produced here without a current molecule-specific registry extract.
• A defensible market size and segmentation for fentanyl hydrochloride cannot be stated without a cited sales dataset and explicit methodology.
• A numeric revenue projection cannot be issued without product-level revenue data and a salt-mapping policy.
• The investable and R&D-relevant variables are formulation delivery, misuse-resistance, and patient workflow alignment, with commercial risk driven by product-level patent and generic entry rather than the fentanyl hydrochloride salt alone.

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FAQs

1) Is fentanyl hydrochloride itself still being researched in new clinical programs?

Yes, but progress is typically centered on formulation delivery improvements and population-specific safety and efficacy rather than new opioid mechanisms.

2) What most determines future market share for fentanyl products?

Formulation performance, payer restrictions, prescribing practices, and the product-level patent/generic landscape by route and strength.

3) Does the clinical evidence focus on analgesic efficacy only?

No. Evidence increasingly emphasizes safety, misuse/diversion risk controls, and consistent performance in real clinical workflows.

4) Why is market sizing difficult for “fentanyl hydrochloride” as a single line item?

Because commercial sales accrue to specific approved products (delivery systems and dosage forms). Converting product sales into a unified “salt” view requires a dataset with a defined mapping.

5) What is the dominant commercial risk for fentanyl-related investments?

Route- and strength-specific generic substitution and regulatory/payer opioid controls that constrain utilization.

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References

[1] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances. https://www.dea.gov/controlled-substances
[2] World Health Organization. (n.d.). WHO guidelines for the management of breakthrough pain in cancer. https://www.who.int/
[3] U.S. Food and Drug Administration. (n.d.). Opioid drugs and REMS resources. https://www.fda.gov/