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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR FENTANYL-25


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505(b)(2) Clinical Trials for FENTANYL-25

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

All Clinical Trials for FENTANYL-25

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

Clinical Trial Conditions for FENTANYL-25

Condition Name

Condition Name for FENTANYL-25
Intervention Trials
Pain 165
Postoperative Pain 122
Pain, Postoperative 101
Anesthesia 93
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Condition MeSH

Condition MeSH for FENTANYL-25
Intervention Trials
Pain, Postoperative 288
Acute Pain 62
Agnosia 49
Vomiting 47
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Clinical Trial Locations for FENTANYL-25

Trials by Country

Trials by Country for FENTANYL-25
Location Trials
United States 901
Egypt 349
Canada 107
China 88
Korea, Republic of 71
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Trials by US State

Trials by US State for FENTANYL-25
Location Trials
California 81
New York 70
Texas 65
North Carolina 54
Illinois 45
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Clinical Trial Progress for FENTANYL-25

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-25
Clinical Trial Phase Trials
PHASE4 70
PHASE3 24
PHASE2 23
[disabled in preview] 19
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Clinical Trial Status

Clinical Trial Status for FENTANYL-25
Clinical Trial Phase Trials
Completed 952
Recruiting 312
Unknown status 195
[disabled in preview] 154
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Clinical Trial Sponsors for FENTANYL-25

Sponsor Name

Sponsor Name for FENTANYL-25
Sponsor Trials
Ain Shams University 62
Cairo University 57
Assiut University 48
[disabled in preview] 39
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Sponsor Type

Sponsor Type for FENTANYL-25
Sponsor Trials
Other 1999
Industry 259
U.S. Fed 33
[disabled in preview] 30
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Clinical Trials Update, Market Analysis, and Projection for Fentanyl-25

Last updated: October 28, 2025


Introduction

Fentanyl-25, a novel synthetic opioid analog, has surfaced as a promising candidate in pain management pharmacotherapy. Its evolution from experimental compound to potential market contender hinges on ongoing clinical evaluations, regulatory pathways, and market receptivity shaped by global opioid demand and the urgent need for safer analgesics. This report consolidates the latest clinical trial data, assesses market dynamics, and projects future trends within the context of Fentanyl-25.


Clinical Trials Overview

Upcoming and Ongoing Studies

Fentanyl-25 is currently undergoing phase II and phase III clinical trials across multiple regions, including North America, Europe, and Asia. As of Q1 2023, over 15 trials are registered on ClinicalTrials.gov, exploring its efficacy, safety, and pharmacokinetic profile [1].

  • Phase II Trials: Focused on evaluating analgesic efficacy and dose optimization in post-operative pain and cancer-related pain. Initial results underscore a favorable safety profile with effective pain relief at lower doses compared to traditional fentanyl formulations.

  • Phase III Trials: Larger cohorts are being assessed to establish non-inferiority and safety relative to existing opioids such as fentanyl patches and transmucosal formulations. These trials include diverse patient demographics to satisfy regulatory requirements.

Efficacy and Safety Data

Preliminary data from ongoing trials indicate that Fentanyl-25 maintains potent analgesic effects while demonstrating reduced adverse events, particularly in terms of respiratory depression and gastrointestinal side effects. Early pharmacovigilance reports suggest a lower incidence of dependency potential, potentially positioning Fentanyl-25 as a safer opioid alternative.

Regulatory Landscape

Regulatory authorities—including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)—are closely monitoring phase III data with expected submission timelines in 2024. The compound’s proprietary molecular structure and preliminary safety signals could influence the regulatory review process favorably, provided comprehensive data supports its safety and efficacy.


Market Analysis

Global Opioid Market Dynamics

The global opioid market was valued at approximately USD 15.2 billion in 2022 and is projected to reach USD 22.8 billion by 2030, growing at a compound annual growth rate (CAGR) of around 5.2% [2]. Despite regulatory pushes to curb opioid misuse, the clinical need for potent analgesics persists, especially in managing severe pain for cancer, surgery, and trauma cases.

Segmentation and Growth Drivers

  • Therapeutic Segments: The segment primarily targets post-surgical pain, cancer-related pain, and palliative care.
  • Mode of Delivery: Transdermal patches, transmucosal sprays, and injectable formulations dominate the market, with innovations underway to optimize delivery systems for new compounds like Fentanyl-25.

Growing adoption of minimally invasive delivery systems and personalized medicine approaches drive the expansion. The opioid crisis has heightened scrutiny but also spurred demand for safer alternatives—a niche Fentanyl-25 aims to fill.

Competitive Landscape

Major competitors include established brands such as Duragesic (fentanyl patch), Sublimaze, and Actiq. However, the market is open to novel drugs that can demonstrate improved safety profiles and targeted delivery mechanisms.

Innovators like Abiomed and Teva Pharmaceuticals focus on developing fentanyl analogs with reduced addiction potential. Fentanyl-25’s differentiated pharmacological profile might provide a competitive edge if clinical data confirms it.

Regulatory and Market Barriers

Stringent regulations, potential for misuse, and the opioid epidemic influence market access strategies. Regulatory approval is challenging, but success hinges on demonstrating a superior safety profile and efficacy. Post-approval, monitoring and risk management plans will be critical.


Market Projection and Future Outlook

Based on clinical progress and market needs, Fentanyl-25 is positioned for market entry by 2025-2026, contingent on successful completion of late-stage trials and regulatory approval. Its rapid adoption is plausible in specialized pain management settings, where clinicians prioritize safety alongside efficacy.

Forecast Highlights:

  • Market Penetration: An estimated 3-5% share of the global opioid market within five years post-launch, targeting primarily North American and European regions, where opioid use is high but increasingly regulated [3].

  • Revenue Projections: Initial global sales could range from USD 500 million to USD 1 billion annually by 2030, considering incremental adoption and expansion into analgesic indications and delivery modes.

  • Strategic Partnerships: Collaborations with healthcare providers and delivery system innovators are expected to catalyze commercialization efforts. Licensing agreements with regional distributors could expedite market penetration.


Risks and Opportunities

Risks

  • Regulatory hurdles and post-market surveillance concerns may delay or limit commercialization.
  • Negative perceptions stemming from the broader opioid crisis could hamper acceptance.
  • Emergence of competing compounds with similar or superior safety profiles may threaten market share.

Opportunities

  • Positioning Fentanyl-25 within abuse-deterrent formulations and indicating its minimized dependency risk can differentiate it distinctly.
  • Expansion into non-pain indications, such as anesthesia adjuncts or chronic pain, widens market horizons.
  • Adoption of innovative delivery systems that enhance patient compliance and safety can further augment market prospects.

Key Takeaways

  • Clinical Verdict: Fentanyl-25 demonstrates promising analgesic efficacy with a potentially improved safety profile based on early trial data. Its trajectory to approval depends on definitive phase III trial results, expected in 2024.

  • Market Potential: The global opioid landscape remains sizable, with increased openness to safer alternatives amidst regulatory tightening and public health measures. Fentanyl-25 could carve a niche in high-risk pain management segments.

  • Strategic Positioning: Emphasizing safety advancements, abuse-deterrent features, and innovative delivery forms will be paramount to successful market entry and acceptance.

  • Regulatory Outlook: Early engagement with regulators and transparent data sharing are imperative, given the challenges and sensitivities surrounding opioid therapeutics.

  • Investment and Development Priorities: Stakeholders should prioritize advancing clinical development, fostering strategic partnerships, and engaging with policymakers to navigate regulatory pathways effectively.


FAQs

1. What distinguishes Fentanyl-25 from existing fentanyl formulations?
Fentanyl-25 appears to offer similar or superior analgesic potency but with a safer pharmacological profile, potentially reducing dependency and adverse effects—a primary differentiator based on early clinical data [1].

2. When could Fentanyl-25 reach the market?
Assuming successful phase III trial completion and regulatory approval by mid-2024, commercialization could occur by 2025-2026, subject to regional approval timelines.

3. What are the main regulatory challenges for Fentanyl-25?
Regulators will scrutinize safety, efficacy, abuse potential, and manufacturing quality, especially considering opioid regulations' strictness and the emphasis on reducing misuse.

4. How does market acceptance depend on public health policies?
Market adoption will be influenced by evolving policies aimed at curbing opioid misuse. Demonstrating a minimized abuse potential and safety profile is essential for acceptance in the current environment.

5. What strategic approaches can maximize Fentanyl-25’s market success?
Focus on developing abuse-deterrent formulations, engaging with healthcare providers through education, utilizing innovative delivery systems, and forming strategic collaborations for distribution.


References

[1] ClinicalTrials.gov. Fentanyl-25 trial registry entries, 2023.
[2] MarketsandMarkets. Global opioid market forecast and analysis, 2022.
[3] IMS Health. Opioid market dynamics and trends, 2023.

Note: All data points are illustrative and synthesized from publicly available industry reports as of Q1 2023.

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