Duragesic

(Fentanyl)

ApprovedSmall molecule

Fentanyl is used to treat severe pain, particularly in cancer patients and people with chronic pain conditions. It can also be used before surgery to help patients relax and reduce anxiety.[2] Duragesic is currently approved and in use across 97 indications[4].[1]

Duragesic is one of 1487 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

519

Total Trials

Active Trials

1,486

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Bone MetastasisApproved

Cirrhosis of LiverActive, not recruiting

AbscessApproved

Neuropathic PainApproved

Low Back PainApproved

Aortic CoarctationApproved

DysphagiaActive, not recruiting

Migraine DisorderApproved

Liver TransplantActive, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Bone MetastasisApproved

Approved

Cirrhosis of LiverPreclinical

Active, not recruiting

AbscessApproved

Approved

Neuropathic PainApproved

Approved

Low Back PainApproved

Approved

Aortic CoarctationApproved

Approved

DysphagiaPreclinical

Active, not recruiting

Migraine DisorderApproved

Approved

Liver TransplantApproved

Active, not recruiting

Showing 10 of 86 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Duragesic

Spikevax

21 3

Bnt162b2

BioNTech

Preclinical

29 4

Biaxin

AbbVie

Preclinical

2 5

Singulair

AstraZeneca

Preclinical

1 6

Statin

Bristol-Myers Squibb

Preclinical

1 7

Olokizumab

UCB

Preclinical

1 8

Antithrombin-III

Octapharma

Preclinical

1 9

Conventional

PPopulation Health Research Institute

Preclinical

1 10

Blood Taken

HHospices Civils de Lyon

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Liver Transplant

NCT06868589

Q4 2026

N/ANot yet recruiting

Sedation

NCT07166666

Post-ApprovalRecruiting

Acute Pain

NCT06364540

Q2 2029

N/ARecruiting

Trial

NCT05609877

Clinical

Trials by Indication[1]

Sedation18 trials

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

Completed·GGuangzhou Institute of Respiratory Disease·Phase 4·NCT03901716·60 enrolled

Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research

Completed·TThe Affiliated Hospital of Qingdao University·N/A·NCT05485064·108 enrolled

Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

Completed·UUniversity of Cologne·Phase 3·NCT00419601·24 enrolled

Show 15 more trials

Magnesium Sulphate Versus Fentanyl Sedation During Burr-hole Surgery

Completed·KKasr El Aini Hospital·Phase 2·NCT03854812·32 enrolled

Sedation Strategies for Diagnostic Bronchoscopy

Terminated·—·N/A·NCT03406533·28 enrolled

Sedation Strategies for Diagnostic Bronchoscopy 2

Unknown status·—·N/A·NCT03983889·200 enrolled

Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)

Not yet recruiting·OOman Medical Speciality Board·N/A·NCT07166666·128 enrolled

Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

Completed·—·Phase 4·NCT01934088·130 enrolled

Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

Completed·KKasr El Aini Hospital·Phase 2·NCT03548493·34 enrolled

Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA

Completed·SScarlata, Simone, M.D.·N/A·NCT06033729·30 enrolled

Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients

Unknown status·FFederal University of São Paulo·Phase 4·NCT00906139·210 enrolled

Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy

Completed·JJiangsu Nhwa Pharmaceutical Co., Ltd.·N/A·NCT01729897·328 enrolled

Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Completed·HHelsinki University Central Hospital·Phase 4·NCT01079312·80 enrolled

The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial

Recruiting·SSiriraj Hospital·N/A·NCT06203405·214 enrolled

Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids

Completed·UUniversity of Athens·N/A·NCT01304342·180 enrolled

Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

Completed·—·Phase 2·NCT03461718·66 enrolled

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Completed·MMedical University of Graz·Phase 4·NCT04026074·50 enrolled

Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology

Active, not recruiting·—·Phase 1·NCT07040163·276 enrolled

Dexmedetomidine6 trials

Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Completed·—·N/A·NCT03463083·60 enrolled

Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Completed·IInje University·N/A·NCT02150759·46 enrolled

Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Completed·TTanta University·Phase 4·NCT04397406·90 enrolled

Show 3 more trials

Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT01508455·6 enrolled

Effects of Dexmedetomidine on the Postoperative Experience in Children

Completed·IInonu University·Phase 4·NCT01748630·42 enrolled

Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block

Recruiting·FFayoum University·Phase 4·NCT06636578·90 enrolled

Fentanyl5 trials

Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

Completed·MMount Sinai Hospital, Canada·Phase 3·NCT06590870·8 enrolled

Effect of Fentanyl on Pain Severity and Duration of Labor

Terminated·MMashhad University of Medical Sciences·Phase 2/3·NCT01648595·70 enrolled

IN Sub-Dissociative Ketamine vs IN Fentanyl

Completed·WWake Forest University Health Sciences·Phase 2·NCT02521415·87 enrolled

Show 2 more trials

Fentanyl as an Adjuvant to Peribulbar Block in Buckle or Squint Surgeries

Unknown status·RResearch Institute of Ophthalmology, Egypt·Phase 1·NCT05539911·50 enrolled

Intranasal Ketamine Versus Intranasal Fentanyl

Completed·IIsfahan University of Medical Sciences·Phase 3·NCT04414800·125 enrolled

Delirium4 trials

Decreasing the Incidence of Delirium After Cardiac Surgery

Withdrawn·UUniversity of California, Los Angeles·Phase 4·NCT02119806

Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients

Unknown status·FFuling Central Hospital of Chongqing City·Phase 4·NCT02225210·80 enrolled

Delirium in Elderly Patients With Trauma of the Hip

Terminated·—·Phase 4·NCT02689024·239 enrolled

Show 1 more trial

Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)

Completed·MMedipol University·Phase 4·NCT06630364·59 enrolled

Erector Spinae Plane Block4 trials

Dexmedetomidine Versus Fentanyl As Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: a Randomized Clinical Trial

Not yet recruiting·—·Phase 2/3·NCT06799442·46 enrolled

Erector Spinae Plane Block in Scoliotic Adolescents

Completed·KKasr El Aini Hospital·Phase 2·NCT03968146·30 enrolled

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy

Unknown status·MMedical University of Warsaw·N/A·NCT03887260·42 enrolled

Show 1 more trial

Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy

Completed·—·Phase 3·NCT04128540·28 enrolled

130 more indications

Bupivacaine4 trials

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

Completed·—·Phase 2/3·NCT03592537·90 enrolled

The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine

Completed·TTanta University·Phase 4·NCT02128451·90 enrolled

Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section

Completed·—·Phase 2·NCT02430090·45 enrolled

Show 1 more trial

Analgesic Additives to Epidural Bupivacaine in Normal Labor

Unknown status·—·N/A·NCT05746351·69 enrolled

Cesarean Section4 trials

Pain Control and Side Effects in Cesarean Section Anesthesia: Comparison of Intrathecal Morphine and Fentanyl

Active, not recruiting·—··NCT07144410·180 enrolled

Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

Completed·QQazvin University Of Medical Sciences·Phase 1/2·NCT01425658·90 enrolled

Intrathecal Midazolam, Fentanyl and Nalbuphine as Adjuvants to Bupivacaine in Spinal Anesthesia for Cesarean Section

Completed·—·N/A·NCT04932083·100 enrolled

Show 1 more trial

Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Terminated·—·N/A·NCT01362998·2 enrolled

Surgery3 trials

Partial Scalp Block in Posterior Fossa Surgery

Completed·KKasr El Aini Hospital·Phase 1·NCT04955236·40 enrolled

Intrathecal Magnesium for Same-day-surgery

Terminated·HHospital General de Ciudad Real·Phase 3·NCT01794247·21 enrolled

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·N/A·NCT03120234·60 enrolled

Agitation3 trials

The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

Completed·PPrince of Songkla University·N/A·NCT01440114·144 enrolled

Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment

Completed·MMedipol University··NCT06097169·80 enrolled

Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy

Completed·BBurak Omur··NCT05986942·80 enrolled

Total Knee Arthroplasty3 trials

Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Completed·—·Phase 4·NCT00562627·102 enrolled

Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Completed·—·N/A·NCT05861791·98 enrolled

Implementation of a Pain Management Protocol for Total Knee Arthroplasty

Completed·HHealth Sciences North Research Institute·Phase 4·NCT02474654·220 enrolled

Anesthesia3 trials

Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

Completed·—·N/A·NCT03806374·120 enrolled

Opioid-based Versus Lidocaine-based Induction of Anesthesia With Propofol in Elderly

Unknown status·KKasr El Aini Hospital·Phase 4·NCT05051007·100 enrolled

Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)

Completed·—·Phase 4·NCT03726268·907 enrolled

Mastectomy2 trials

Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction

Completed·UUniversity of California, San Francisco·Phase 4·NCT01258296·60 enrolled

Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia

Completed·UUdayana University·N/A·NCT04435925·48 enrolled

Laparoscopic Cholecystectomy2 trials

Intravenous Lidocaine for Laparoscopic Cholecystectomy

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·N/A·NCT01062906·80 enrolled

Post-operative Pain Relief in Laparoscopic Cholecystectomy

Unknown status·—·N/A·NCT03355716·120 enrolled

Total Intravenous Anesthesia2 trials

Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function

Completed·MMedical University Innsbruck·Phase 4·NCT00706277·60 enrolled

Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Recruiting·ZZagazig University·N/A·NCT07105618·108 enrolled

Intensive Care Unit2 trials

Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

Terminated·UUniversity of Chicago·Phase 4·NCT01059929·41 enrolled

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00875550·175 enrolled

Spinal Anesthesia2 trials

Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients

Completed·YYonsei University·N/A·NCT01608334·56 enrolled

Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia

Withdrawn·PPravara Institute of Medical Sciences University·N/A·NCT01205204

Chronic Obstructive Pulmonary Disease2 trials

Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)

Completed·QQueen's University·N/A·NCT00974220·16 enrolled

Impact of Muscle Afferent Feedback During Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed·LLaval University·N/A·NCT01522729·8 enrolled

Osteoarthritis2 trials

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, Compared With Placebo in Patients With Osteoarthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00236366·418 enrolled

A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01008618·218 enrolled

Cancer Pain2 trials

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research··NCT01946555·150 enrolled

Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00216658·87 enrolled

Cardiac Surgery2 trials

Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery

Unknown status·WWestern University, Canada·N/A·NCT03128346·100 enrolled

Remifentanil and Glycemic Response in Cardiac Surgery

Completed·UUnknown Sponsor·Phase 4·NCT02349152·116 enrolled

Effectiveness2 trials

Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention

Completed·HHaEmek Medical Center, Israel·Phase 4·NCT02125201·21 enrolled

Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

Unknown status·—·Phase 4·NCT04872881·52 enrolled

Mechanically Ventilated Patients2 trials

Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care Unit

Unknown status·SSoutheast University, China·Phase 3·NCT05641909·138 enrolled

Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine in Mechanically Ventilated Patients

Unknown status·WWest China Hospital·Phase 4·NCT02528513·240 enrolled

Breakthrough Pain2 trials

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain

Completed·—·Phase 4·NCT01846221·101 enrolled

Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)

Completed·NNycomed·Phase 2·NCT00345735·150 enrolled

Epidural Analgesia2 trials

Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia

Completed·GGrace Lim, MD, MS·Phase 2·NCT05487196·88 enrolled

Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

Unknown status·—·N/A·NCT03595397·60 enrolled

Bariatric Surgery2 trials

Ketamine in Bariatric Surgery

Unknown status·UUniversity of Padova·Phase 3·NCT01724983·90 enrolled

Ketamine for Pain Relief in Bariatric Surgery

Completed·SSir Ganga Ram Hospital·Phase 4·NCT03052673·76 enrolled

Chronic pain2 trials

An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00788372·142 enrolled

Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain

Suspended·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 4·NCT00916890·320 enrolled

Postoperative Analgesia2 trials

Postoperative Analgesia Impact of Narcotic Free Anesthesia

Completed·UUniversité de Sherbrooke·N/A·NCT01544959·84 enrolled

The Effect of Dexmedetomidine on Postoperative Analgesia

Completed·SSeoul National University Hospital·Phase 4·NCT01373021·95 enrolled

Intrathecal Dexmedetomidine2 trials

Clinical Comparative Study Aiming to Evaluate Postoperative Effect of Using Intrathecal Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Lower Limb Vascular Surgeries on Pain Intensity, Analgesic Requirement and Shivering. Patients and Methods After Approval of Medical Institution

Completed·NNashwa Ahmed·Phase 4·NCT07035223·40 enrolled

A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture

Completed·—·Phase 1·NCT06502262·60 enrolled

Mechanical Ventilation2 trials

Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT04436224·530 enrolled

Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation

Recruiting·—·Phase 2·NCT07224620·300 enrolled

Intravenous2 trials

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery

Completed·—·Phase 1·NCT06867068·73 enrolled

Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

Completed·IINSYS Therapeutics Inc·Phase 1·NCT02576353·50 enrolled

Children1 trial

Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children

Completed·TThe Hospital for Sick Children·Phase 3·NCT00405444·64 enrolled

Severe Pain1 trial

Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain

Terminated·MMercy Health Ohio·Phase 4·NCT03959852·6 enrolled

Intensive Care1 trial

The Pharmacokinetics of Fentanyl in Intensive Care Patients

Unknown status·OOslo University Hospital·Phase 4·NCT02587273·150 enrolled

Inguinal hernia1 trial

Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery

Recruiting·KKasr El Aini Hospital·Phase 2·NCT06326944·50 enrolled

Portal Hypertension1 trial

Impact of Fentanyl Analgesia on the Accuracy of HVPG Measurements in Patients With Portal Hypertension

Unknown status·HHepatopancreatobiliary Surgery Institute of Gansu Province·N/A·NCT04724148·4 enrolled

Ventricular Tachycardia1 trial

Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia

Completed·—·N/A·NCT02419547·11 enrolled

Immune Response1 trial

Pain, Opioids and Pro-Inflammatory Immune Responses

Terminated·UUniversity of California, Los Angeles·Phase 1·NCT01210066·21 enrolled

Hemodynamic Stability1 trial

Lidocaine Versus Fentanyl for Hemodynamic Stability

Completed·TTheodor Bilharz Research Institute·Phase 4·NCT06557473·40 enrolled

Brachytherapy1 trial

Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy

Completed·—·Phase 4·NCT02684942·40 enrolled

Perioperative Pain Control1 trial

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Unknown status·UUniversity of Illinois College of Medicine at Peoria·Phase 4·NCT02958566·80 enrolled

Concentration1 trial

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Completed·FFederal University of São Paulo·N/A·NCT00635986·30 enrolled

Laparotomy1 trial

Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy

Completed·—·Phase 4·NCT06772727·149 enrolled

Critically Ill Patients1 trial

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

Completed·—·Phase 4·NCT03030911·30 enrolled

Hypotension1 trial

Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

Completed·KKasr El Aini Hospital·Phase 2·NCT03015857·200 enrolled

Tracheal Intubation1 trial

Opioid-based Versus Opioid-free Endotracheal Intubation

Completed·—·N/A·NCT06464393·70 enrolled

Oxidative Stress1 trial

Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

Unknown status·ZZhujiang Hospital·Phase 4·NCT02202239·60 enrolled

Opioid1 trial

DOSE Trial of Opioid Sparing Effect

Terminated·—·Phase 1·NCT03938857·30 enrolled

Spinal Fusion1 trial

Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT03115151·46 enrolled

Patient-controlled Intravenous Analgesia1 trial

Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl

Completed·EEgymedicalpedia·Phase 1·NCT05429567·70 enrolled

Drug1 trial

Modeling and Application of Triple Drug Response Surface Models

Completed·TTaipei Veterans General Hospital, Taiwan··NCT03813875·100 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Opioid Free Anesthesia1 trial

Opioid-free Anesthesia in Laparoscopic Cholecystectomies

Unknown status·—·N/A·NCT05089526·70 enrolled

Analgesic Efficacy1 trial

RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 4·NCT01809106·518 enrolled

Experimental1 trial

Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Completed·UUniversity of Aarhus·Phase 3·NCT00647127·22 enrolled

Pilot Study1 trial

Ketamine Pilot Study

Terminated·MMeghan Spyres·Phase 4·NCT05379179·3 enrolled

Erector Spinae Block1 trial

Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block

Completed·TTanta University·N/A·NCT05596227·180 enrolled

Midazolam1 trial

Analgesic Effects of Midazolam in Human Volunteers

Completed·WWilhelminenspital Vienna·Phase 4·NCT02629146·24 enrolled

Hemodynamic Response1 trial

Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application

Completed·KKhon Kaen University·Phase 4·NCT03077503·60 enrolled

Renal Colic1 trial

Nasal Fentanyl And Renal Colic

Completed·VValduce Hospital·N/A·NCT01339624·65 enrolled

Post Operative Pain1 trial

Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain

Completed·YYeungnam University College of Medicine·N/A·NCT03204045·90 enrolled

Hyperalgesia1 trial

Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean

Unknown status·PPontificia Universidad Catolica de Chile·Phase 4·NCT02387060·80 enrolled

Postoperative Pain Relief1 trial

Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine

Completed·UUniversidad de Antioquia·Phase 3·NCT02145975·60 enrolled

Tics1 trial

Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

Withdrawn·SSeoul National University Hospital·N/A·NCT03763305

Cancer-related Pain1 trial

Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

Recruiting·EErasmus Medical Center·Phase 4·NCT06498037·45 enrolled

Platelet Reactivity1 trial

Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

Terminated·CCorewell Health South·Phase 2·NCT05367336·21 enrolled

Intraoperative1 trial

The Effect of Intraoperative Labetalol on Time to Discharge

Completed·—·Phase 2·NCT02997800·172 enrolled

Kidney Transplant1 trial

Methadone Anesthesia For Kidney Transplant Receptors

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 3·NCT04908345·32 enrolled

Local Infiltration1 trial

Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery

Withdrawn·UUniversity of Pennsylvania·N/A·NCT02970097

Side Effects1 trial

Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

Completed·SSt. Luke's-Roosevelt Hospital Center·N/A·NCT02159807·170 enrolled

Strabismus1 trial

Pain Medications in Children Undergoing Strabismus Surgery

Unknown status·—·N/A·NCT02789969·128 enrolled

Coronary Artery Disease1 trial

A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease

Unknown status·KKasr El Aini Hospital·N/A·NCT05502211·100 enrolled

Hysterectomy1 trial

Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

Completed·PPreben Kjolhede·Phase 4·NCT00527332·180 enrolled

Hyperbaric Bupivacaine1 trial

Dexmedetomidine and Fentanyl As Adjuvants to Hyperbaric Bupivacaine for the Prevention of Post-spinal Shivering in Hip Arthroplasty Surgeries

Unknown status·—·N/A·NCT06834841·100 enrolled

Heart Failure1 trial

Mechanisms of Altered Ventilatory Control in Heart Failure

Completed·MMayo Clinic·N/A·NCT02421341·28 enrolled

Migraine1 trial

Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Completed·KKocaeli University·Phase 4·NCT02314351·148 enrolled

Laryngeal Mask Airway1 trial

Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management

Completed·—·Phase 4·NCT01368809·100 enrolled

Remimazolam1 trial

Remimazolam Phase II Cardiac Anesthesia Study

Completed·PPaion UK Ltd.·Phase 2·NCT01937767·90 enrolled

Liver Disease1 trial

Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03063866·100 enrolled

Abdominal Surgeries1 trial

Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries

Completed·TTanta University·N/A·NCT06994273·54 enrolled

Irritable Bowel Syndrome1 trial

Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00108446

Abscess1 trial

Pain Management in ED for Incision and Drainage of Abscess

Withdrawn·UUniversity of California, Los Angeles·Phase 4·NCT01881997

Medication1 trial

Pain Reduction With Intranasal Medications for Extremity Injuries

Completed·—·Phase 3·NCT02778880·90 enrolled

Umbilical hernia1 trial

U.S. Guided Erector Spinae Block for Postoperative Pain Management in Paraumbilical Hernia Repair Patients

Unknown status·—··NCT06120088·300 enrolled

Torticollis1 trial

Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Completed·—·Phase 4·NCT02651311·32 enrolled

Efficacy and Safety1 trial

Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia

Completed·RR-Pharm·Phase 3·NCT03669484·150 enrolled

Renal Protection1 trial

Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Completed·MMansoura University·N/A·NCT03265470·100 enrolled

Analgesia1 trial

Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

Unknown status·MMansoura University·Phase 4·NCT04223219·90 enrolled

Oral Mucositis1 trial

Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients

Unknown status·—·Phase 4·NCT04292990·300 enrolled

Liver Transplant1 trial

Reducing Pain With Methadone and Ketamine in Liver Transplant

Recruiting·LLahey Clinic·Phase 4·NCT06868589·50 enrolled

Neuromuscular Block1 trial

Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

Unknown status·TTC Erciyes University·N/A·NCT03424356·96 enrolled

Hemorrhage1 trial

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT04136548·41 enrolled

Pain Control1 trial

Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Completed·UUniversity of Hawaii·N/A·NCT03057041·107 enrolled

Acute Pain1 trial

Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED

Recruiting·AAntonios Likourezos·Phase 4·NCT06364540·150 enrolled

Safety and Efficacy1 trial

Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse

Completed·HHurd,Yasmin, Ph.D.·Phase 1·NCT01311778·18 enrolled

Total Knee Replacement1 trial

Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

Completed·UUniversity of South Florida·N/A·NCT01620047·60 enrolled

Dexamethasone1 trial

Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery

Unknown status·—·Phase 2/3·NCT05145543·80 enrolled

Low back pain1 trial

Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain

Completed·PPriCara, Unit of Ortho-McNeil, Inc.·Phase 4·NCT00237341·358 enrolled

Opioid Consumption1 trial

Influence of Dexmedetomidine and Lidocaine on Opioid Consumption in Laparoscopic Intestine Resection

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02616523·60 enrolled

Lower Limb Orthopedic Surgery1 trial

Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery

Completed·QQazvin University Of Medical Sciences·Phase 1/2·NCT01205997·90 enrolled

Femur Fracture1 trial

Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

Completed·—·N/A·NCT02983344·24 enrolled

Nausea1 trial

Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

Completed·SStony Brook University·Phase 4·NCT03435003·83 enrolled

Opioid Analgesia1 trial

μ-opioid Receptor Polymorphism and Opioid Analgesia

Completed·—··NCT02099877·250 enrolled

Staphylococcus Aureus1 trial

Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

Completed·—·N/A·NCT07285759·40 enrolled

Cesarean Delivery1 trial

TAP Block With Intrathecal Fentanyl vs. Intrathecal Morphine in Cesarean Delivery

Completed·SSeoul National University Hospital·N/A·NCT04824274·80 enrolled

Vomiting1 trial

Comparison Between IT Fentanyl and IV Granisetron in Prevention of Vomiting in CS Under Spinal Anesthesia

Unknown status·MMohamed Youssef Mohamed·N/A·NCT05474001·90 enrolled

Clinical Trial1 trial

Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00216684·139 enrolled

Patient-Controlled Analgesia1 trial

Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control

Unknown status·YYonsei University··NCT01527890·2,000 enrolled

Trial1 trial

The NONA-LISA Trial

Recruiting·RRigshospitalet, Denmark·N/A·NCT05609877·324 enrolled

Vaginal Delivery1 trial

Single Shot Intrathecal Analgesia in Vaginal Delivery

Unknown status·—·N/A·NCT05998551·75 enrolled

Pain Management1 trial

Pain Management After Forefoot Surgery

Completed·TTurku University Hospital·Phase 4·NCT01666379·60 enrolled

General Anesthesia1 trial

Neuronal Mechanisms of Sensory Processing During General Anesthesia

Unknown status·LLudwig-Maximilians - University of Munich·N/A·NCT00434382·768 enrolled

Subarachnoid Anesthesia1 trial

Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.

Completed·SSaint Savvas Anticancer Hospital·Phase 2/3·NCT03260283·104 enrolled

Exercise1 trial

Muscle Reflex Inhibition in Hypoxic Exercise

Unknown status·UUniversity of British Columbia·N/A·NCT05619887·14 enrolled

Knee Arthroscopy1 trial

Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Completed·ZZagazig University·N/A·NCT04442906·45 enrolled

Serratus Anterior Plane Block1 trial

Serratus Anterior Plane Block in Pediatric Patients

Completed·—·N/A·NCT04444635·70 enrolled

Colonoscopy1 trial

Comparison of Efficacy of Anesthesia Administered by Endoscopist or Anesthesiologist on Colonoscopy

Completed·SSelda KAYAALTI··NCT03607110·120 enrolled

Percutaneous Coronary Intervention1 trial

Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

Terminated·TThe Guthrie Clinic·Phase 4·NCT03476369·45 enrolled

Amputation1 trial

Epidural Calcitonin in Lower Limb Amputation

Completed·TTanta University·N/A·NCT02115360·60 enrolled

Hernia1 trial

Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery

Completed·IIsfahan University of Medical Sciences·Phase 4·NCT01843296·105 enrolled

Major Depressive Disorder1 trial

Ketamine Co-induction for Patients With Major Depressive Disorder

Unknown status·UUniversity of Saskatchewan·Phase 4·NCT03666494·50 enrolled

Labor Analgesia1 trial

Comparison of PIEB vs CEI for Labor Analgesia

Completed·—·Phase 4·NCT02949271·179 enrolled

Bronchoscopy1 trial

Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Withdrawn·—·Phase 4·NCT03613792

After Cardiac Surgery1 trial

Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

Completed·—·N/A·NCT06907277·75 enrolled

Oocyte Retrieval1 trial

Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization

Terminated·UUniversity of South Florida·Phase 4·NCT03732469·4 enrolled

Nausea and vomiting1 trial

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Inflammatory Response1 trial

Inflammatory Response to Opioid Versus Opioid Free Anesthesia

Completed·UUniversity of Guadalajara·N/A·NCT04854252·40 enrolled

Natural Killer Cell1 trial

Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

Unknown status·HHillel Yaffe Medical Center·N/A·NCT02326727·30 enrolled

Bunion1 trial

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Completed·CConcentric Analgesics·Phase 2·NCT03885596·36 enrolled

Prostate Cancer1 trial

Prothrombotic Factors and Anaesthesia in Prostate Cancer

Completed·RRegina Elena Cancer Institute·N/A·NCT01998685·200 enrolled

Obstructive Sleep Apnea1 trial

Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea

Unknown status·UUniversity of Malaya·Phase 1·NCT02014714·40 enrolled

Hypothermia1 trial

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

Completed·RRegion Skane··NCT03177980·49 enrolled

Analgesic1 trial

Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 4·NCT01708122·71 enrolled

Congestive Heart Failure1 trial

The Use of Intranasal Fentanyl for the Treatment of Incident Dyspnea in Congestive Heart Failure: A Prospective Trial

Completed·—·Phase 2·NCT02454751·8 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

Completed·—·N/A·NCT04285255·103 enrolled

Unspecified1 trial

Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

Completed·TTanta University·N/A·NCT04518618·96 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

SUBLIMAZE PRESERVATIVE FREE

NDA NDA016619

Jan 12, 1985

FENTANYL CITRATE

NDA NDA019115

Aug 7, 1990

DURAGESIC-100

NDA NDA019813

Oct 30, 1995

FENTANYL

NDA NDA020195

Nov 4, 1998

ACTIQ

NDA NDA020747

May 22, 2006

IONSYS

NDA NDA021338

Sep 25, 2006

FENTORA

NDA NDA021947

Jul 16, 2009

ONSOLIS

NDA NDA022266

Jan 7, 2011

ABSTRAL

NDA NDA022510

Jun 30, 2011

LAZANDA

NDA NDA022569

Jan 4, 2012

SUBSYS

NDA NDA202788

Jan 20, 2023

FENTANYL CITRATE

NDA NDA019101

Feb 8, 2023

FENTANYL CITRATE

NDA NDA215870

Sources

References

[1]
ClinicalTrials.gov — 519 trial records for Fentanyl. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Duragesic drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fentanyl compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fentanyl. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215870). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Duragesic. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Cephalon company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mu Opioid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCephalon

Patent Landscape[6]

Patent Cliff

Jan 25, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9241935Jan 25, 2027

10016403Jan 25, 2027

8835460Jan 25, 2027

10610523Jan 25, 2027

9642797Jan 25, 2027

16 more patents

9289387Jan 25, 2027

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9597288Jul 23, 2027

7862832Jun 15, 2028

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8486972Apr 27, 2030

8486973Apr 27, 2030

9364656Sep 30, 2031

8301238Sep 30, 2031

9731121Oct 17, 2031

9731869Jan 26, 2032

8781571Mar 31, 2032

8428708May 21, 2032

8428709Jun 11, 2032

9095706Feb 3, 2033