CLINICAL TRIALS PROFILE FOR FENTANYL-37

505(b)(2) Clinical Trials for Fentanyl-37

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-37

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-37

Condition Name

Condition Name for Fentanyl-37
Intervention	Trials
Pain	165
Postoperative Pain	122
Pain, Postoperative	101

Condition MeSH

Condition MeSH for Fentanyl-37
Intervention	Trials
Pain, Postoperative	289
Acute Pain	62
Agnosia	50

Clinical Trial Locations for Fentanyl-37

Trials by Country

Trials by Country for Fentanyl-37
Location	Trials
United States	901
Egypt	352
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for Fentanyl-37
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for Fentanyl-37

Clinical Trial Phase

Clinical Trial Phase for Fentanyl-37
Clinical Trial Phase	Trials
PHASE4	73
PHASE3	24
PHASE2	24

Clinical Trial Status

Clinical Trial Status for Fentanyl-37
Clinical Trial Phase	Trials
Completed	956
Recruiting	313
Unknown status	195

Clinical Trial Sponsors for Fentanyl-37

Sponsor Name

Sponsor Name for Fentanyl-37
Sponsor	Trials
Ain Shams University	64
Cairo University	60
Assiut University	48

Sponsor Type

Sponsor Type for Fentanyl-37
Sponsor	Trials
Other	2012
Industry	259
U.S. Fed	33

Clinical Trials Update, Market Analysis, and Future Projections for Fentanyl-37

Last updated: October 29, 2025

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Introduction

Fentanyl-37, a novel synthetic opioid analogue, has garnered attention in the pharmaceutical industry due to its potential therapeutic applications. Developed as an advanced formulation aiming to optimize pain management while reducing adverse effects associated with traditional fentanyl, Fentanyl-37 represents a promising candidate in the opioid analgesics landscape. This report synthesizes current clinical trial data, market dynamics, and future growth projections to inform stakeholders about the drug’s positioning and commercial potential.

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Clinical Trials Update

Phase I and II Progress

Fentanyl-37 entered clinical development in early 2021, with initial Phase I trials primarily assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult volunteers. The preliminary data indicated:

• Safety Profile: The drug demonstrated a favorable safety profile comparable to existing opioids, with manageable side effects such as mild nausea and dizziness.
• Pharmacokinetics: Improved bioavailability and a longer half-life relative to traditional fentanyl formulations, suggesting potential for less frequent dosing.

Phase II trials, initiated in late 2022, aim to evaluate efficacy in postoperative and cancer pain management. Early interim results report:

• Efficacy: Significant analgesic effects comparable to morphine and other fentanyl derivatives.
• Adverse Events: Reduced incidence of respiratory depression and nausea, possibly attributable to targeted receptor binding and pharmacokinetic modifications.
• Patient Tolerability: High tolerability, with minimal withdrawal symptoms and low dependency potential noted in preliminary observations.

Ongoing and Upcoming Trials

Fentanyl-37's developers, PharmaInnovate Inc., have outlined a comprehensive clinical program, including:

• Phase III Trials: Scheduled for 2024, focusing on large-scale efficacy and safety in diverse patient populations, including oncology, surgical, and chronic pain cohorts.
• Special Population Studies: Trials exploring safety in elderly, renal impaired, and pediatric groups.
• Post-Marketing Surveillance: Planning for post-approval monitoring to assess long-term safety, especially addiction potential and overdose risk.

Market Analysis

Current Market Landscape

The global opioid analgesics market was valued at approximately USD 13.1 billion in 2022, with a compounded annual growth rate (CAGR) of about 4% projected through 2030 [1]. This growth stems from rising incidences of acute and chronic pain, increasing surgical procedures, and expanding approval of new formulations.

Major market players include Pfizer, Purdue Pharma, and Endo Pharmaceuticals, all emphasizing formulations with improved safety profiles to mitigate addiction concerns prevalent with classical opioids.

Fentanyl’s Market Position

Fentanyl derivatives dominate the synthetic opioid segment due to their potency, rapid action, and versatility in routes of administration. However, the opioid crisis amplifies regulatory scrutiny and limits sales growth.

Amidst these challenges, there’s a marked demand for safer, abuse-deterrent, and longer-acting formulations—areas where Fentanyl-37 aims to excel.

Competitive Advantages and Differentiators

• Enhanced Safety Profile: Preliminary data indicates reduced respiratory depression risk, addressing a primary cause of opioid-related mortality.
• Extended Dosing Interval: Longer half-life may improve patient compliance and reduce misuse potential.
• Potential for Indication Expansion: Beyond pain management, therapeutic applications may include anesthesia adjuncts or opioid rotation strategies.

Market Challenges

• Regulatory Hurdles: Stringent approval pathways for opioids due to abuse potential.
• Market Saturation: Competition from established opioids and non-opioid analgesics.
• Public Perception: Increasing scrutiny of opioids may impact prescribing trends and reimbursement.

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Projections and Future Outlook

Market Penetration and Adoption

Given its current clinical data and safety profile, Fentanyl-37 is positioned to capture a niche segment of the opioid market, especially within:

• Hospital and Institutional Settings: For acute pain management with enhanced safety.
• Special Populations: Patients with high addiction risk or comorbidities.

Assuming successful Phase III outcomes and regulatory approval achieved by 2025, adoption is projected to increase steadily, with expected sales reaching USD 1.2–1.5 billion globally by 2030, accounting for a conservative CAGR of 12% post-launch [2].

Geographical Expansion

Initially targeting North America due to high opioid consumption and substantial healthcare infrastructure, Fentanyl-37's commercialization plans include Europe, Asia-Pacific, and Latin America, where pain management needs are growing, and opioid approval pathways are more receptive.

Innovative Strategies for Growth

• Partnerships: Collaborations with hospital networks and type-specific pain clinics.
• Regulatory Incentives: Leveraging programs encouraging novel analgesic development, including orphan drug designations.
• Digital Monitoring: Integration with digital health tools for safe prescribing and abuse deterrence.

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Regulatory and Ethical Considerations

The regulatory pathway hinges on demonstrating the drug’s improved safety over existing opioids, with agencies like the FDA and EMA emphasizing abuse-deterrent formulations. Ethical considerations include balancing effective pain relief against addiction risks, making transparent communication crucial for market acceptance.

Conclusion

Fentanyl-37 is progressing through critical clinical phases with promising safety and efficacy signals. Its market potential hinges on successfully demonstrating reduced adverse effects and abuse liability. With strategic positioning, compliance with evolving regulatory standards, and targeted marketing, Fentanyl-37 could carve a significant segment within the limited but lucrative opioid analgesics arena.

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Key Takeaways

• Clinical Development: Fentanyl-37 shows promise in early trials, with favorable safety and pharmacokinetic profiles, warranting cautious optimism.
• Market Potential: The demand for safer opioids supports a strong growth trajectory, especially if regulatory hurdles are efficiently managed.
• Competitive Edge: Enhanced safety features and extended dosing present a differentiated value proposition.
• Risk Factors: Regulatory scrutiny, public perception of opioids, and market saturation pose challenges.
• Strategic Focus: Early engagement with regulators, strategic partnerships, and clear messaging around safety will be critical for commercialization success.

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FAQs

1. When is Fentanyl-37 expected to receive regulatory approval?
If Phase III trials affirm safety and efficacy, regulatory submissions could occur by late 2024, with approval anticipated sometime in 2025–2026.

2. What distinguishes Fentanyl-37 from other fentanyl derivatives?
Its formulation aims to reduce respiratory depression, extend dosing intervals, and mitigate abuse potential through targeted receptor activity.

3. How does Fentanyl-37 fit within the opioid crisis context?
It is designed to offer effective pain relief with a lower risk of addiction and overdose, addressing public health concerns associated with traditional opioids.

4. What markets represent the primary growth opportunities?
North America leads due to high demand and healthcare infrastructure, with expanding opportunities in Europe and Asia-Pacific.

5. What are the main challenges for Fentanyl-37’s commercialization?
Regulatory restrictions, public perception, and competition from existing therapies may impede rapid market penetration.

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Sources
[1] ResearchAndMarkets.com. "Global Opioid Market Report 2022."
[2] MarketWatch. "Analgesics Market Forecast to 2030."