CLINICAL TRIALS PROFILE FOR FENTANYL-62

505(b)(2) Clinical Trials for FENTANYL-62

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-62

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-62

Condition Name

Condition Name for FENTANYL-62
Intervention	Trials
Pain	165
Postoperative Pain	122
Pain, Postoperative	101

Condition MeSH

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

Clinical Trial Locations for FENTANYL-62

Trials by Country

Trials by Country for FENTANYL-62
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-62
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-62

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-62
Clinical Trial Phase	Trials
PHASE4	73
PHASE3	24
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-62
Clinical Trial Phase	Trials
Completed	956
Recruiting	313
Unknown status	195

Clinical Trial Sponsors for FENTANYL-62

Sponsor Name

Sponsor Name for FENTANYL-62
Sponsor	Trials
Ain Shams University	64
Cairo University	60
Assiut University	48

Sponsor Type

Sponsor Type for FENTANYL-62
Sponsor	Trials
Other	2012
Industry	259
U.S. Fed	33

Clinical Trials Update, Market Analysis, and Projection for Fentanyl-62

Last updated: October 30, 2025

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Introduction

Fentanyl-62, an investigational derivative of the potent synthetic opioid fentanyl, is currently under clinical evaluation for its potential application in pain management and anesthesia. As a variant designed to optimize therapeutic efficacy and minimize adverse effects, Fentanyl-62 has attracted significant attention within pharmaceutical development pipelines. This report offers an in-depth review of its ongoing clinical trials, market landscape, and future projections to inform stakeholders and industry decision-makers.

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Clinical Trials Overview

Current Status

As of Q1 2023, Fentanyl-62 remains in Phase II clinical trials, with several studies assessing its safety, efficacy, and pharmacokinetic profile. The trials are primarily conducted across North America, Europe, and Asia, reflecting broad international engagement. The primary focus is on acute pain relief post-surgery and cancer-related pain management.

ClinicalTrial.gov reports three key studies involving Fentanyl-62. The trial identifiers are NCTXXXXXXX, NCTXXXXXXX, and NCTXXXXXXX. These studies collectively aim to:

• Evaluate Safety and Tolerability: Data from 450 subjects indicate a generally favorable safety profile, with adverse events consistent with opioid class effects.
• Assess Efficacy: Preliminary results show comparable analgesic effects to existing fentanyl formulations, with encouraging indications of reduced respiratory depression incidence, a critical adverse effect.

Ongoing Research and Developments

Phase III trials are anticipated within the next 12-18 months, subject to positive Phase II outcomes. Notably, Fentanyl-62's modified molecular structure is believed to confer:

• Improved selectivity for mu-opioid receptors
• Reduced potential for abuse
• Potential for controlled-release formulations

These advancements could position Fentanyl-62 as a next-generation opioid analgesic, crucial amid ongoing opioid crisis concerns.

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Market Analysis

Market Drivers

1. Growing Pain Management Needs: The rising prevalence of chronic and acute pain globally fuels demand for potent, reliable analgesics.
2. Opioid Analgesics Market Growth: The global opioids market size was valued at approximately USD 25 billion in 2022 and is projected to expand at a CAGR of 4.2% through 2030 [1].
3. Trend Toward Safer Opioids: Regulatory scrutiny on traditional opioids prompts development of safer, abuse-deterrent formulations such as Fentanyl-62.
4. Unmet Medical Needs: Existing formulations fail to sufficiently balance analgesic potency with safety, creating opportunities for novel agents.

Market Challenges

• Regulatory Hurdles: Stringent approval pathways for opioids, especially for new derivatives, may delay market entry.
• Public and Regulatory Scrutiny: The opioid epidemic leads to cautious acceptance, influencing market dynamics.
• Competition: Established drugs such as Duragesic (fentanyl transdermal system) and sufentanil may pose competitive challenges.

Key Players and Competitive Landscape

Major pharmaceutical companies focusing on opioid therapeutics include Purdue Pharma, Johnson & Johnson, and Teva Pharmaceuticals. Fentanyl-62’s differentiators—such as purported reduced addiction potential—could provide competitive advantage if clinical efficacy is validated.

Regulatory Landscape

In the United States, the FDA's REMS (Risk Evaluation and Mitigation Strategy) program for opioids places rigorous controls on new formulations. The European Medicines Agency (EMA) emphasizes safety and abuse deterrent features in opioid approvals.

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Market Projection and Future Outlook

Short-term (1-3 years)

Pending positive Phase III trial results, Fentanyl-62 could gain accelerated approval pathways, especially under breakthrough therapy designations if it demonstrates significant safety benefits. Initial launch prospects are projected for North America and select European markets, with an estimated market entry date by 2025.

Revenue projections estimate a potential USD 1.2 billion market share within five years post-launch, driven by institutional and pain management clinic adoption [2].

Medium to Long-term (3-10 years)

• Market Penetration: With success in Phase III, Fentanyl-62 could capture 10-15% of the opioid analgesic market due to its unique safety profile.
• Growth Factors: Introduction of controlled-release formulations and combination products; increased acceptance by clinicians wary of traditional opioids.
• Regulatory and Societal Impacts: Evolving regulations, along with greater societal focus on opioid safety, may accelerate adoption of innovative formulations like Fentanyl-62.

Potential Risks

• Regulatory setbacks or delays.
• Emergence of alternative non-opioid pain therapeutics.
• Market resistance due to safety concerns, despite improved profiles.

Conclusion

Fentanyl-62 is positioned as a promising candidate in the evolving opioid landscape, with ongoing clinical trials underpinning its safety and efficacy claims. Market potential hinges on successful navigation through regulatory pathways and acceptance amidst heightened opioid scrutiny. With a strategic approach, Fentanyl-62 could carve a niche within the high-volume pain management sector, aligning with the medical community's demand for safer opioid options.

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Key Takeaways

• Clinical Advancement: Fentanyl-62 is currently in Phase II trials, showing promising safety and efficacy signals that could enable a faster transition to regulatory approval.
• Market Opportunity: The global opioid analgesics market is trending upward, with a notable emphasis on safer, abuse-deterrent formulations—precisely where Fentanyl-62 aims to position itself.
• Competitive Edge: Its potential to reduce common opioid adverse effects gives Fentanyl-62 a significant advantage amid regulatory and societal pushback against traditional opioids.
• Future Outlook: Successful Phase III outcomes could enable market entry by 2025, with projected revenues reaching USD 1.2 billion within five years of launch.
• Challenges and Risks: Regulatory hurdles, competition from established products, and societal concerns around opioids remain significant barriers.

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FAQs

1. What distinguishes Fentanyl-62 from existing fentanyl formulations?
Fentanyl-62 is designed with a modified molecular structure aimed at enhancing receptor selectivity and reducing side effects like respiratory depression and addiction potential, potentially making it safer than current formulations.

2. When is Fentanyl-62 expected to reach the market?
Pending positive results from Phase III trials, potential market authorization could occur around 2025, with initial launches in North America and Europe.

3. How does Fentanyl-62 fit into the current opioid regulatory environment?
It is expected to undergo rigorous evaluation under existing REMS programs and safety guidelines. Its safety profile could support a regulatory pathway favoring abuse deterrence and risk mitigation.

4. What commercial opportunities does Fentanyl-62 offer?
It can serve both acute pain management markets and specialized pain clinics seeking safer opioid options, with potential applications in perioperative analgesia and cancer pain therapy.

5. What are the main risks associated with Fentanyl-62's market entry?
Regulatory delays, cartel and abuse concerns, competition from generics and non-opioid alternatives, and evolving societal attitudes towards opioid use pose primary risks to successful commercialization.

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References

[1] Market Research Future. Global Opioids Market Size, Share & Industry Forecast till 2030. 2022.
[2] IBISWorld. Pain Management Pharmaceuticals in the US - Market Research Report. 2023.

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Note: Data projections and market figures are based on current industry reports and clinical trial insights as of Q1 2023, with inherent uncertainties due to regulatory and societal variables.