CLINICAL TRIALS PROFILE FOR FENTANYL-100

505(b)(2) Clinical Trials for FENTANYL-100

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.

All Clinical Trials for FENTANYL-100

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.

Clinical Trial Conditions for FENTANYL-100

Condition Name

Condition Name for FENTANYL-100
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101

Condition MeSH

Condition MeSH for FENTANYL-100
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51

Clinical Trial Locations for FENTANYL-100

Trials by Country

Trials by Country for FENTANYL-100
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-100
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-100

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-100
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-100
Clinical Trial Phase	Trials
Completed	962
Recruiting	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL-100

Sponsor Name

Sponsor Name for FENTANYL-100
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for FENTANYL-100
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Last updated: April 28, 2026

Fentanyl-100: Clinical Trials Update, Market Analysis, and Projection

What is “Fentanyl-100”?

No regulated, branded, or clearly defined drug entity named “Fentanyl-100” is identifiable from standard public drug and trial registries as a standalone active ingredient product designation. “Fentanyl” is the controlled active ingredient; “-100” is not a universally recognized strength, formulation, or INN suffix that maps consistently to a single marketed or trial-listed product in major databases.

Because a precise product identity is not determinable from the provided label alone, a complete, accurate clinical trials update and market projection for “Fentanyl-100” cannot be produced.

Which clinical trials are tied to Fentanyl-100?

No complete, product-specific set of interventional studies can be reliably attributed to a distinct entity called Fentanyl-100 without an unambiguous mapping to a known formulation/strength (for example: specific brands, dosage forms, or coded investigational products). A trials update requires an exact product identifier to avoid mixing:

• trials for fentanyl in general,
• trials for specific fentanyl formulations (patch, buccal, intranasal, sublingual, injectable),
• trials for different delivery systems (transdermal vs rapid-onset),
• trials in different indications and dosing regimes.

No authoritative trial dataset can be built for “Fentanyl-100” as stated.

How does the market analysis work when the product identity is unclear?

A market analysis must anchor to:

• jurisdictional approvals (EMA/FDA/other),
• labeled indications and dose forms,
• distribution channels,
• pricing and reimbursement,
• safety regulation impact,
• competitive landscape by formulation type.

Without a determinable product identity behind “Fentanyl-100,” any market size, share, or projection would risk attributing fentanyl market activity to the wrong product segment.

What projections can be made?

No defensible market projection can be generated for “Fentanyl-100” without knowing whether it is:

• a specific fentanyl dosage form (transdermal patch, intranasal, buccal film, sublingual tablet, etc.),
• a specific release profile (immediate-release vs extended-release),
• a specific brand or investigational code that drives pricing and adoption.

A projection depends on product-level uptake drivers (formulary inclusion, payer coverage, indication expansion, and competitive substitution), which cannot be mapped from the label alone.

---

Key Takeaways

• “Fentanyl-100” is not uniquely identifiable as a distinct regulated product in standard public frameworks from the provided name alone.
• A complete, accurate clinical trials update cannot be produced without a determinable product mapping to a specific fentanyl formulation/strength or investigational identifier.
• Market analysis and projections require product-level identity (dosage form, release type, labeled indication, and geography). The provided label does not support that mapping.

FAQs

1. Is “Fentanyl-100” a known fentanyl strength or formulation category?
   No widely consistent public mapping exists for a standalone “-100” designation that uniquely defines a fentanyl product entity.

2. Can I use general fentanyl trial data to represent “Fentanyl-100”?
   No, product-specific trials differ by formulation, indication, pharmacokinetics, and dosing. Aggregating “fentanyl” trials would not be accurate for a specific entity named “Fentanyl-100.”

3. What market segment would “Fentanyl-100” likely belong to?
   Without knowing dosage form and release profile, it cannot be assigned to a specific segment with credible sizing or competitive context.

4. Does fentanyl’s controlled status change how projections should be modeled?
   Yes, but regulation impacts differ by jurisdiction and product form. Product identity is required to model payer, access, and compliance effects.

5. What is required to produce an investment-grade update for this drug name?
   An unambiguous mapping to a specific branded product, investigational code, dosage form, and release profile so trials, approvals, and market data are correctly linked.

---

References

[1] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
[2] European Medicines Agency. (n.d.). Human medicines. https://www.ema.europa.eu/en/human-regulatory/overview-human-medicines
[3] ClinicalTrials.gov. (n.d.). https://clinicaltrials.gov/
[4] World Health Organization. (n.d.). Fentanyl. https://www.who.int/health-topics/controlled-substances