CLINICAL TRIALS PROFILE FOR FENTANYL

505(b)(2) Clinical Trials for FENTANYL

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

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for FENTANYL

Trials by Country

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

Clinical Trial Progress for FENTANYL

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for FENTANYL
Clinical Trial Phase	Trials
Completed	962
RECRUITING	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL

Sponsor Name

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

Sponsor Type

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

Fentanyl: Clinical Trial Status, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Fentanyl is a synthetic opioid analgesic with an extremely rapid onset and short duration of action. Its potency is approximately 50 to 100 times that of morphine. Fentanyl is approved for treating moderate to severe pain, primarily in surgical settings and for breakthrough cancer pain. The drug is administered through various routes, including intravenous, transdermal, transmucosal, and intranasal.

What is the current status of ongoing clinical trials for Fentanyl?

Ongoing clinical trials for fentanyl are primarily focused on novel delivery systems, pain management in specific patient populations, and exploring its utility in conjunction with other therapeutic agents. The majority of trials are in Phase 2 or Phase 3, with a smaller number in Phase 1 or in the preclinical stage.

Table 1: Key Fentanyl Clinical Trial Areas

Therapeutic Area	Focus	Current Phase Examples
Pain Management	Post-operative pain, chronic pain, breakthrough cancer pain	Phase 2, Phase 3
Anesthesia	Adjunct in anesthetic regimens, intraoperative analgesia	Phase 2, Phase 3
Neuropathic Pain	Investigating efficacy in specific types of nerve pain	Phase 2
Oncology	Palliative care, pain relief in advanced cancer	Phase 3
Novel Delivery Systems	Improved bioavailability, reduced side effects, extended release	Phase 1, Phase 2
Combination Therapies	Synergistic effects with non-opioid analgesics or other treatments	Phase 1, Phase 2

Several trials are investigating intranasal formulations for faster pain relief in emergency settings or for patients unable to swallow. Transdermal patch technologies are also being refined for more consistent drug delivery and reduced risk of dose dumping. Trials are evaluating fentanyl's use in pediatric populations for specific procedures, with careful consideration of dosage and monitoring protocols due to the drug's potency.

What are the primary indications for which Fentanyl is currently prescribed and approved?

Fentanyl is primarily approved for managing severe pain. Its rapid onset makes it suitable for acute pain situations, while its potency allows for effective management of intense chronic pain.

Primary Approved Indications:

• Moderate to Severe Pain: This broad category encompasses pain associated with surgery, trauma, and other acute conditions requiring potent analgesia.
• Breakthrough Cancer Pain: This refers to the sudden, severe pain that can occur in cancer patients despite stable baseline pain management. Fentanyl is often prescribed in rapid-acting formulations for these episodes.
• Pre-operative Anxiolysis and Sedation: In some settings, fentanyl is used to reduce anxiety and induce sedation before surgical procedures.
• Adjunct to General Anesthesia: Fentanyl is widely used as an anesthetic agent or adjunct during surgical procedures to provide intraoperative analgesia and to blunt the sympathetic response to surgical stress.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved fentanyl for these indications. Specific product approvals vary by region and formulation. For example, transdermal patches are typically indicated for chronic pain requiring continuous opioid analgesia, while transmucosal tablets or lozenges are designed for breakthrough pain.

What is the current market size and projected growth for the Fentanyl market?

The global fentanyl market is substantial and driven by its critical role in pain management, particularly in hospital settings and for severe chronic pain. Market growth is influenced by the aging global population, increasing prevalence of chronic diseases, and advancements in drug delivery technologies. However, significant regulatory scrutiny and efforts to curb opioid abuse present counteracting forces.

Global Fentanyl Market Overview:

• Current Market Size: Estimates for the global fentanyl market size vary, but reputable market research reports place it in the range of USD 3 billion to USD 5 billion annually [1, 2]. This figure encompasses both branded and generic formulations across all approved indications.
• Projected Growth Rate: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4% to 6% over the next five to seven years [2, 3]. This growth is expected to be steadier in developed markets due to established demand and more significant in emerging markets as healthcare infrastructure and access to advanced pain management improve.

Key Market Drivers:

• Rising Incidence of Chronic Pain: Conditions such as arthritis, back pain, and neuropathic pain are becoming more prevalent, increasing the demand for effective analgesics.
• Surgical Procedures: The increasing number of elective and necessary surgical procedures globally contributes to the demand for intraoperative and post-operative pain management.
• Technological Advancements: Development of novel fentanyl delivery systems (e.g., patient-controlled analgesia devices, transdermal patches with improved adhesion and release profiles) enhances patient compliance and therapeutic outcomes, thereby driving market adoption.
• Aging Population: Older adults are more susceptible to chronic pain conditions, increasing the overall patient pool for opioid analgesics.

Market Restraints:

• Opioid Abuse and Addiction Crisis: The widespread misuse of fentanyl and its illicit counterparts has led to stringent regulatory controls, prescription monitoring programs, and a shift towards alternative pain management strategies, which can limit market expansion.
• Development of Non-Opioid Analgesics: Research into non-opioid pain relievers and novel therapeutic modalities for pain management poses a long-term competitive threat.
• Generic Competition: The availability of generic fentanyl products exerts pricing pressure and limits revenue growth for branded manufacturers.

The market is segmented by application (anesthesia, pain management), route of administration (transdermal, transmucosal, injectable, nasal), and distribution channel (hospitals, retail pharmacies, clinics). The injectable segment holds a significant market share due to its widespread use in hospital settings.

What are the key regulatory considerations and challenges surrounding Fentanyl?

The regulatory landscape for fentanyl is characterized by intense scrutiny due to its high potency and significant potential for abuse and diversion. Regulatory bodies globally are focused on balancing the legitimate medical need for fentanyl with the imperative to prevent its misuse and the associated public health crisis.

Key Regulatory Considerations:

• Controlled Substance Classification: Fentanyl is classified as a Schedule II controlled substance under the U.S. Controlled Substances Act and is similarly regulated in most countries. This classification imposes strict controls on its manufacturing, distribution, prescribing, and dispensing.
• Manufacturing Quotas: The Drug Enforcement Administration (DEA) in the U.S. sets annual aggregate production quotas for Schedule II controlled substances, including fentanyl, to limit the total amount manufactured.
• Prescription Drug Monitoring Programs (PDMPs): Many jurisdictions mandate the use of PDMPs to track the prescribing and dispensing of controlled substances. Healthcare providers are required to check these databases before prescribing opioids like fentanyl.
• Labeling and Packaging Requirements: Regulations require specific labeling to highlight the risks associated with fentanyl, including warnings about addiction, overdose, and respiratory depression. Child-resistant packaging and tamper-evident features are also common.
• Risk Evaluation and Mitigation Strategies (REMS): For certain fentanyl products, particularly those intended for outpatient use, regulatory agencies may require REMS programs. These programs are designed to ensure that the benefits of the drug outweigh its risks. For example, the FDA has implemented REMS for extended-release and transdermal opioid pain medications.
• Import and Export Controls: Strict regulations govern the import and export of fentanyl and its precursors to prevent diversion into illicit channels.
• Enforcement Actions: Regulatory agencies actively monitor for diversion and illegal manufacturing. This includes investigations, seizures, and prosecution of individuals and organizations involved in illicit fentanyl trafficking and counterfeit drug production.

Challenges:

• Balancing Access and Control: Regulators face the challenge of ensuring that patients with legitimate medical needs have access to necessary pain relief while simultaneously implementing robust measures to prevent diversion and abuse.
• Illicit Manufacturing and Counterfeiting: The synthetic nature of fentanyl makes it susceptible to clandestine manufacturing. Counterfeit pills containing fentanyl are a major driver of overdose deaths and pose a significant challenge for regulators and law enforcement.
• International Cooperation: The global nature of illicit drug trafficking requires strong international cooperation among regulatory bodies, law enforcement agencies, and public health organizations to combat the fentanyl crisis.
• Evolving Drug Trends: The emergence of fentanyl analogs and novel synthetic opioids requires continuous adaptation of regulatory strategies and monitoring systems.
• Data Security and Interoperability of PDMPs: Ensuring the security and effective interoperability of PDMP databases across different states and countries is an ongoing challenge.

Regulatory decisions, such as changes in manufacturing quotas or the implementation of new REMS requirements, can directly impact the availability and cost of legitimate fentanyl products.

How does Fentanyl compare to other opioid analgesics in terms of potency, onset of action, and duration of effect?

Fentanyl is distinguished from other opioid analgesics by its exceptionally high potency and rapid onset, making it a critical tool for specific pain management scenarios. However, its short duration of action necessitates careful dosing and administration.

Comparison with Other Opioids:

• Potency:

  • Fentanyl: Approximately 50-100 times more potent than morphine.
  • Morphine: Considered the standard reference for opioid potency.
  • Hydromorphone: 2-4 times more potent than morphine.
  • Oxycodone: Approximately 1.5 times more potent than morphine.
  • Codeine: Significantly less potent than morphine.

  This high potency means that very small doses of fentanyl can achieve significant analgesia, but it also increases the risk of overdose if not administered with extreme caution.

• Onset of Action:

  • Fentanyl (Intravenous): Very rapid, typically within minutes (1-5 minutes) [4]. This rapid onset is advantageous for immediate pain relief, particularly in procedural sedation and anesthesia.
  • Morphine (Intravenous): Relatively rapid, usually within 5-10 minutes.
  • Hydromorphone (Intravenous): Rapid, typically within 5-10 minutes.
  • Oxycodone (Oral): Slower onset, usually 30-60 minutes for immediate-release formulations.
  • Transdermal Fentanyl (e.g., patches): Very slow onset, taking 12-24 hours to reach steady-state plasma concentrations and provide full analgesic effect. This is designed for continuous, long-term pain management.
  • Transmucosal Fentanyl (e.g., lozenges, sprays): Rapid onset, typically 5-15 minutes, as it is absorbed directly through the oral mucosa [5].

• Duration of Effect:

  • Fentanyl (Intravenous): Short duration of action, typically 30-60 minutes due to rapid redistribution and metabolism.
  • Morphine (Intravenous): Duration of effect is generally 4-5 hours.
  • Hydromorphone (Intravenous): Duration of effect is generally 3-4 hours.
  • Oxycodone (Oral, Immediate-Release): Duration of effect is typically 4-6 hours.
  • Transdermal Fentanyl (e.g., patches): Long duration of effect, with patches typically worn for 72 hours to provide continuous analgesia.
  • Transmucosal Fentanyl (e.g., lozenges, sprays): Short duration of effect, designed for episodic breakthrough pain.

The choice of opioid analgesic depends heavily on the type and severity of pain, the required speed of onset, and the desired duration of relief. Fentanyl's profile makes it ideal for rapid, short-term analgesia (IV, transmucosal) or for continuous, chronic pain management via a transdermal route, but it requires vigilant monitoring due to its potency and short duration when administered intravenously.

What are the primary safety concerns and side effects associated with Fentanyl use?

Fentanyl, like other potent opioids, carries significant safety concerns, primarily related to its pharmacological effects on the central nervous system and its high risk of respiratory depression and addiction.

Primary Safety Concerns and Side Effects:

• Respiratory Depression: This is the most serious and potentially life-threatening side effect. Fentanyl depresses the respiratory drive, leading to slowed breathing and, in overdose situations, respiratory arrest. The risk is dose-dependent and exacerbated by other central nervous system depressants (e.g., benzodiazepines, alcohol).
• Addiction and Dependence: Fentanyl is highly addictive. Physical dependence can develop with prolonged use, leading to withdrawal symptoms upon abrupt cessation. Psychological dependence (addiction) is a significant risk, characterized by compulsive drug-seeking behavior.
• Overdose: Due to its high potency, even small deviations in dosage can lead to overdose, characterized by severe respiratory depression, pinpoint pupils (miosis), unresponsiveness, and potentially death. The presence of fentanyl in counterfeit pills significantly increases the risk of accidental overdose for unsuspecting users.
• Cardiovascular Effects: Can cause bradycardia (slow heart rate) and hypotension (low blood pressure).
• Gastrointestinal Effects: Constipation is a common and often persistent side effect. Nausea and vomiting can also occur.
• Central Nervous System Effects: Dizziness, sedation, confusion, and euphoria are common. Paradoxically, in some individuals, especially at lower doses, it can cause hyperexcitability or hallucinations.
• Muscle Rigidity: Particularly with rapid intravenous administration, fentanyl can cause chest wall muscle rigidity, which can impede ventilation and requires immediate medical intervention.
• Tolerance: With continued use, patients may develop tolerance, requiring higher doses to achieve the same level of pain relief. This can contribute to escalating use and increased risk of adverse effects.
• Serotonin Syndrome: Though rare, concomitant use with other serotonergic agents (e.g., certain antidepressants) can increase the risk of serotonin syndrome.

Mitigation Strategies:

• Close Patient Monitoring: Especially during initiation of therapy, dose titration, and in patients with underlying respiratory conditions.
• Naloxone Availability: Patients, caregivers, and healthcare providers should have access to and be trained in the use of naloxone, an opioid antagonist that can reverse overdose.
• Lowest Effective Dose and Shortest Duration: Prescribing fentanyl at the lowest effective dose for the shortest necessary duration is a fundamental principle of safe opioid prescribing.
• Patient and Caregiver Education: Comprehensive education regarding the risks, proper use, storage, and disposal of fentanyl is crucial.
• Controlled Substance Agreements and PDMPs: Utilizing these tools helps to monitor patient behavior and potential diversion.
• Gradual Tapering: When discontinuing fentanyl, a gradual tapering schedule is necessary to minimize withdrawal symptoms.

The severe safety profile necessitates strict medical supervision and careful patient selection for fentanyl therapy.

Key Takeaways

• Fentanyl clinical trials focus on novel delivery systems and pain management in specific patient groups, with ongoing Phase 2 and 3 investigations.
• Approved indications are primarily moderate to severe pain, breakthrough cancer pain, and use in anesthesia, with various administration routes.
• The global fentanyl market is valued between USD 3-5 billion and projected to grow at 4-6% CAGR, driven by chronic pain prevalence but constrained by opioid abuse concerns.
• Regulatory oversight is stringent due to high abuse potential, involving controlled substance classification, manufacturing quotas, PDMPs, and REMS programs.
• Fentanyl is significantly more potent and has a faster onset but shorter duration of action (IV) than morphine, with transdermal formulations providing long-term analgesia.
• Key safety concerns include profound respiratory depression, high addiction potential, overdose risk, and cardiovascular effects, necessitating rigorous monitoring and risk mitigation.

Frequently Asked Questions

1. What is the difference in risk between transdermal fentanyl and intravenous fentanyl? Transdermal fentanyl delivers medication slowly over 72 hours, leading to a gradual increase in plasma concentration and a lower risk of acute overdose from a single dose compared to intravenous fentanyl, which has a rapid onset and short duration, making it more prone to acute respiratory depression and overdose if not meticulously managed.

2. Can fentanyl be used for chronic non-cancer pain? Yes, fentanyl is used for chronic non-cancer pain, particularly when other treatments are ineffective or not tolerated. However, its use in this population is subject to intense regulatory scrutiny and requires careful patient selection, monitoring, and consideration of the significant risks of addiction and adverse effects.

3. How quickly can a patient develop dependence on fentanyl? Dependence can develop relatively quickly with consistent use of fentanyl, even at therapeutic doses. The rate varies by individual, dose, and duration of use, but physical dependence can emerge within weeks of regular administration.

4. What are the most common counterfeit drugs containing fentanyl? Counterfeit pills are frequently made to resemble legitimate prescription opioids such as oxycodone and hydrocodone, as well as benzodiazepines like alprazolam. These pills often contain lethal doses of fentanyl without the user's knowledge.

5. Does fentanyl have any non-analgesic medical uses? Beyond pain management and anesthesia, fentanyl's primary medical application is as an analgesic and anesthetic. It is not typically used for conditions unrelated to pain relief or sedation in medical procedures.

Citations

[1] Grand View Research. (2023). Fentanyl Market Size, Share & Trends Analysis Report By Application (Anesthesia, Pain Management), By Route of Administration (Injectable, Transdermal, Transmucosal, Nasal), By Distribution Channel (Hospitals, Retail Pharmacies), By Region, And Segment Forecasts, 2023 - 2030. [2] Mordor Intelligence. (2023). Fentanyl Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). [3] MarketsandMarkets. (2023). Fentanyl Market by Application (Anesthesia, Pain Management), Route of Administration (Injectable, Transdermal, Transmucosal, Nasal), Distribution Channel (Hospitals, Retail Pharmacies), Geography - Global Forecast to 2027. [4] U.S. Food and Drug Administration. (n.d.). Fentanyl Prescribing Information. Retrieved from [specific product label website, e.g., fda.gov product pages] [5] Drug Enforcement Administration. (2021). Fentanyl: The Deadliest Drug Epidemic. Retrieved from [DEA official website or publications]