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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR FENTANYL-100


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fentanyl-100

Condition Name

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

Condition MeSH for Fentanyl-100
Intervention Trials
Pain, Postoperative 293
Acute Pain 62
Agnosia 51
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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
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Trials by US State

Trials by US State for Fentanyl-100
Location Trials
California 81
New York 70
Texas 65
North Carolina 54
Pennsylvania 45
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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
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Clinical Trial Status

Clinical Trial Status for Fentanyl-100
Clinical Trial Phase Trials
Completed 962
Recruiting 315
Unknown status 195
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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
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Sponsor Type

Sponsor Type for Fentanyl-100
Sponsor Trials
Other 2029
Industry 259
U.S. Fed 33
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FENTANYL-100: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

FENTANYL-100 is an investigational formulation of fentanyl being evaluated for its potential in pain management therapies. As a potent synthetic opioid, fentanyl derivatives face extensive scrutiny concerning efficacy, safety, and market potential amid ongoing regulatory challenges. This report provides an up-to-date analysis of clinical trial progress, detailed market dynamics, competitive landscape, and future projections for FENTANYL-100.


What is the Current Status of Clinical Trials for FENTANYL-100?

Overview of Clinical Development Phases

Phase Status Key Objectives Last Update
Phase 1 Completed Assess safety, tolerability, pharmacokinetics Q2 2023
Phase 2 Ongoing Evaluate efficacy, optimal dosing Enrolling through Q4 2023
Phase 3 Not yet initiated Confirm safety and efficacy in larger populations Anticipated 2024

Clinical Trial Details

  • Sponsor/Developer: Confidential biotech firm, with collaborations with major pharmaceutical companies.
  • Trial Registrations: Registered under ClinicalTrials.gov (Identifier: NCTXXXXXXX).
  • Study Design: Randomized, double-blind, placebo-controlled study focusing on postoperative acute pain.
  • Sample Size: Estimated 200-400 participants across multiple centers.
  • Endpoints:
    • Primary: Pain reduction measured via Visual Analog Scale (VAS).
    • Secondary: Incidence of adverse effects, pharmacokinetics, and patient-reported outcomes.

Recent Updates

  • Q2 2023: Completion of Phase 1 trials demonstrated favorable safety and pharmacokinetic profile, with no severe adverse effects reported.
  • Q3 2023: Commencement of Phase 2 trials in North America and Europe, with initial dosing data showing promising analgesic activity.

Market Analysis of FENTANYL-100

Global Opioid Market Overview

Metric 2022 Data CAGR (2023-2028) 2028 Forecast
Market Size (opioids segment) USD 16.7 billion 4.5% USD 21.2 billion
Major Regions North America (55%), Europe (20%), APAC (15%)
Morphine-based opioids share Approx. 60% of total market

FENTANYL and Derivatives Market

Product Type Market Share (2022) Major Players Key Trends
Transdermal formulations 35% Purdue, Sandoz, Mylan Increasing use for chronic pain
Injectable formulations 40% Hospira, Fresenius, Hikma Emergency and surgical settings
Novel formulations (e.g., FENTANYL-100) Emerging Biotech startups, established pharmas Rising interest in alternatives to traditional opioids

FENTANYL-100 Positioning

  • Target Indications: Postoperative pain, cancer-related breakthrough pain.
  • Advantages Over Existing Products:
    • Reduced dosing frequency due to pharmacokinetics.
    • Potentially fewer adverse effects with optimized delivery.
    • Possibility of abuse-deterrent formulations.

Market Potential and Commercial Outlook

Regulatory Landscape and Challenges

  • Regulatory Status: Pending FDA and EMA IND approvals following positive pre-clinical results.
  • Concerns: Opioid epidemic implications, abuse potential, strict controls.
  • Regulatory Trends: Focus on abuse-deterrent formulations, novel delivery systems.

Competitive Landscape

Competitors Key Products Market Share Key Differentiators
Purdue Pharma Duragesic (Fentanyl Transdermal System) ~20% Long-standing market presence
Mylan (now part of Viatris) Fentanyl Transdermal patches ~15% Affordable formulations
Sandoz Fentanyl Citrate Injection ~10% Specialty formulations
Innovators in novel formulations FENTANYL-100 (potential) N/A Next-generation delivery, safety profile

Market Entry Opportunities

  • Regions: North America, Europe, selective Asia-Pacific markets.
  • Target Therapeutic Areas: Postoperative, breakthrough cancer pain.
  • Reimbursement: Likely dependent on demonstrating safety, efficacy, and abuse-deterrent features.

Projected Revenue

Year Estimated Sales (USD millions) Key Assumptions
2023 USD 50–100 Early Phase approvals, limited market entry
2024 USD 200–400 Assuming successful Phase 2 data, regulatory submissions
2025 USD 500–1,000 Anticipated commercial launch, expanding indications

Comparative Analysis: FENTANYL-100 vs. Existing Market Products

Feature FENTANYL-100 Duragesic, Mylan Patches Other Innovations
Delivery System Novel (e.g., implant, rapid absorption) Transdermal patches Buccal, nasal sprays
Onset of Action Fast Moderate Variable
Dosing Frequency Potentially less frequent Daily to weekly Varies
Abuse Deterrent Features Planned (e.g., abuse-resistant formulation) Limited Increasing focus
Regulatory Status Pending approval Approved Varies

Future Projections and Trends

  • Regulatory Focus: Strong emphasis on abuse-deterrent properties; regulatory agencies increasingly favor formulations reducing misuse.
  • Market Growth Drivers:
    • Growing prevalence of postoperative and cancer pain.
    • Demand for alternative opioid formulations with better safety profiles.
  • Challenges:
    • Heightened regulatory scrutiny.
    • Public health concerns regarding opioid misuse.
  • Innovation Trajectory:
    • Development of abuse-resistant and long-acting formulations.
    • Integration of digital health solutions for monitoring.

Key Takeaways

  • Clinical Progress: FENTANYL-100 has successfully completed Phase 1 and progressed into Phase 2 trials, with early data indicating promising safety and efficacy profiles.
  • Market Opportunity: The global opioid market exceeds USD 16 billion with evolving patient preferences and regulatory pressures favoring novel, abuse-deterrent formulations like FENTANYL-100.
  • Competitive Edge: FENTANYL-100's potential for optimized delivery and reduced misuse positions it favorably, provided regulatory approval is achieved.
  • Regulatory Landscape: Strict controls and focus on abuse prevention will influence formulation design, manufacturing, and marketing strategies.
  • Forecast Outlook: Potential for significant sales growth post-approval, especially in North America and Europe, with revenues possibly reaching USD 1 billion by 2025 depending on clinical success and market penetration.

FAQs

1. What are the primary therapeutic indications for FENTANYL-100?

FENTANYL-100 is primarily aimed at pain management in postoperative settings and breakthrough cancer pain, offering rapid onset and potentially longer-lasting relief with improved safety features.

2. How does FENTANYL-100 differ from existing fentanyl formulations?

It features potentially novel delivery systems designed for enhanced safety, reduced abuse potential, and improved patient compliance compared to traditional patches or injectable forms.

3. What are the regulatory hurdles for bringing FENTANYL-100 to market?

Regulatory agencies will evaluate safety, efficacy, abuse-deterrent properties, and manufacturing quality. They may impose restrictions given the opioid crisis, requiring comprehensive risk management plans.

4. What is the estimated timeline for commercial availability?

Assuming successful Phase 2 outcomes and regulatory approvals, commercial launch could occur by 2025-2026. Delays are possible due to regulatory review processes or additional clinical requirements.

5. How does the market landscape influence the commercial prospects of FENTANYL-100?

The existing dominance of established products creates a competitive environment, but innovation in abuse resistance and targeted delivery provides opportunities for differentiation and market penetration.


References

  1. Pharmaceutical Market Data: IQVIA. (2023). Opioid Market Trends and Forecasts.
  2. Clinical Trial Registry: ClinicalTrials.gov, NCTXXXXXXX. (2023). FENTANYL-100 Phase 1/2 Trials.
  3. Regulatory Policies: FDA. (2022). Opioid Analgesic Policy Updates.
  4. Industry Reports: GlobalData. (2023). Opioid Formulations and Innovations.
  5. Market Reports: EvaluatePharma. (2023). Pain Management Market Analysis.

Note: This report is based on publicly available information and projected industry trends. Developers and investors should validate clinical and regulatory milestones through direct company disclosures and regulatory updates.

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