CLINICAL TRIALS PROFILE FOR FENTANYL-12

505(b)(2) Clinical Trials for FENTANYL-12

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.

All Clinical Trials for FENTANYL-12

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.

Clinical Trial Conditions for FENTANYL-12

Condition Name

Condition Name for FENTANYL-12
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

Condition MeSH for FENTANYL-12
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51
Hypotension	47

Clinical Trial Locations for FENTANYL-12

Trials by Country

Trials by Country for FENTANYL-12
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-12
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-12

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-12
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-12
Clinical Trial Phase	Trials
Completed	962
RECRUITING	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL-12

Sponsor Name

Sponsor Name for FENTANYL-12
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for FENTANYL-12
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Last updated: May 21, 2026

Fentanyl-12 clinical trials update, market analysis, and projection

No complete, citable public record was identified for a drug product specifically named “Fentanyl-12” with sufficient specificity to support an evidence-based clinical-trials update, FDA/regulatory status, market sizing, forecast modeling, or competitor/patent-risk mapping.

What is “Fentanyl-12” and which active ingredient or product does it correspond to?

A “Fentanyl-12” label is not uniquely attributable to a single, identifiable fentanyl drug development program or marketed product in public regulatory and clinical-trials indexing without additional product-defining details (for example: salt form, delivery system, sponsor, NCT identifier, or FDA submission reference). Without that, any attempt to compile trial status, enrollment/completion dates, endpoints, or market trajectory would risk mixing distinct fentanyl formulations and programs.

Which fentanyl programs are commonly confused with investigational “fentanyl” names?

Fentanyl development and marketing activity is dominated by identifiable, indexed entities such as:

• Transdermal fentanyl products (various brand and generic equivalents)
• Oral transmucosal fentanyl products (OTFC/OTM categories, depending on geography and era)
• Intranasal fentanyl (where applicable)
• Injectable fentanyl formulations (generic and specialty variants)
• Extended-release opioid formulations
• Novel delivery systems and reformulations (again, indexed by sponsor and dosage form)

A “Fentanyl-12” placeholder cannot be reliably mapped to one of these categories using publicly citable identifiers alone.

What clinical trials exist for Fentanyl-12, and what are the latest results?

A clinical-trials update requires at minimum one of:

• NCT identifiers
• sponsor name and protocol title tied to the exact investigational product
• dosage form and strength tied to a single development program
• regulatory milestone tied to a named fentanyl product

No such uniquely identifying record could be produced for “Fentanyl-12” from the available information context, so no accurate trial-state timeline (ongoing, completed, results posted, or planned) can be compiled.

What endpoints and trial phases would be expected for a fentanyl development program?

Where fentanyl formulations are developed, typical registrational endpoints include:

• analgesic efficacy and onset metrics (pain intensity reduction; time-to-effect)
• safety in opioid-naïve and opioid-tolerant cohorts
• abuse-deterrence or PK/BD alignment where reformulation is the differentiator
• respiratory depression and somnolence safety monitoring

However, without a specific program match, mapping “Fentanyl-12” to any endpoint set would be speculative.

When does Fentanyl-12 lose market exclusivity and what are the key IP and exclusivity drivers?

Exclusivity and patent timelines require a specific product identity and the relevant reference listed drug (RLD) mapping. For fentanyl products, exclusivity is driven by:

• New Chemical Entity or New Drug Application exclusivity (where applicable)
• 505(b)(2) or 505(j) pathways and reference product
• Orange Book patent family coverage by method, formulation, and use
• data and exclusivity periods, then generic or 505(b)(2) entry risk

Because “Fentanyl-12” cannot be reliably mapped to a specific NDA/BLA reference or Orange Book listing from the provided input context, no loss-of-exclusivity date, Paragraph IV risk, or launch calendar can be produced without fabrication.

What is the Orange Book status of Fentanyl-12?

Orange Book status requires an NDA/BLA number or RLD name match. “Fentanyl-12” does not provide enough unique information to identify an Orange Book listing. No authoritative Orange Book table (patent numbers, expiration dates, and exclusivity codes) can be assembled.

What is the market size, pricing, and revenue potential for Fentanyl-12?

Market sizing for fentanyl depends on:

• exact dosage form (transdermal vs transmucosal vs intranasal vs injectable vs extended-release oral)
• geography (US, EU5, UK, Japan, LATAM)
• channel mix (hospital vs retail vs specialty)
• whether the product is new-to-market or a reformulation relative to an established reference
• patient population definition (cancer breakthrough pain vs chronic pain vs acute pain)

No credible market model can be generated for “Fentanyl-12” without a product-to-category mapping.

How would a generic or biosimilar compete with Fentanyl-12, and what entry risks exist?

Fentanyl is generally small-molecule, so biosimilar framing is not applicable unless the program is a different biologic (it is not). Generic entry risks depend on:

• Orange Book patent and exclusivity expiration
• formulation switching barriers (bioequivalence feasibility, complex-release technology)
• REMS and risk-management burdens for opioid products (where applicable)
• labeling scope protection via method-of-use patents

No specific patent or exclusivity landscape can be attributed to “Fentanyl-12” from the available input.

Which companies are developing or commercializing Fentanyl-12?

Company attribution requires sponsor/manufacturer identifiers tied to the exact development program or marketed product. With “Fentanyl-12” as the only label, no reliably citable list of sponsors, licensors, or competitors can be produced.

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Key Takeaways

• “Fentanyl-12” is not uniquely identifiable from the provided input to produce a factual clinical-trials update, regulatory status, exclusivity timeline, or market projection.
• Any attempt to compile NCT-by-NCT trial status, Orange Book listings, or revenue forecasts would require a product-defining identifier that is not present in the query.

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FAQs

1. How do I map an investigational fentanyl label to an FDA NDA for exclusivity tracking?
2. What trial endpoints matter most for fentanyl formulation reformulations (PK/PD vs clinical analgesia)?
3. How is Paragraph IV litigation typically triggered for opioid reformulations?
4. What categories of fentanyl products drive hospital versus retail uptake, and how does that affect forecasts?
5. What Orange Book fields are most predictive of generic entry timing for extended-release and transmucosal products?

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References

(No sources were cited because no uniquely identifiable “Fentanyl-12” program or listing could be confirmed from the provided input context.)