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 95 indications[4].[1]

Duragesic is one of 1185 small molecule programs targeting Post Operative Pain. It is currently in Approved.

Indications

524

Total Trials

Active Trials

1,184

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Post Operative PainCompleted

Respiratory FailureActive, not recruiting

CognitionActive, not recruiting

Adolescent Idiopathic ScoliosisActive, not recruiting

HysterectomyActive, not recruiting

Septic ShockActive, not recruiting

MigraineActive, not recruiting

Major Depressive DisorderActive, not recruiting

Platelet AggregationActive, not recruiting

Migraine DisorderApproved

Post Operative PainApproved

Completed

Respiratory FailureApproved

Active, not recruiting

CognitionApproved

Active, not recruiting

Adolescent Idiopathic ScoliosisApproved

Active, not recruiting

HysterectomyApproved

Active, not recruiting

Septic ShockApproved

Active, not recruiting

MigraineApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

Platelet AggregationApproved

Active, not recruiting

Migraine DisorderApproved

Approved

Showing 10 of 86 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Duragesic

CCephalon

Approved

1 2

Adenocard

Astellas

Preclinical

2 3

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Acupan

YYonsei University

Preclinical

1 7

Chantix

PPrism Pharmaceuticals

Preclinical

1 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Paracetamol

GSK

Preclinical

1 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ANot yet recruiting

Cataract

NCT07347886

Post-ApprovalNot yet recruiting

Abdominal Cancer Surgeries

NCT07214714

N/ANot yet recruiting

Laparoscopic Sleeve Gastrectomy

NCT07246447

Recruiting

Extracorporeal Membrane Oxygenation

NCT03593408

Q1 2027

Post-ApprovalNot yet recruiting

Lidocaine

NCT06696586

Post-ApprovalRecruiting

Adolescent Idiopathic Scoliosis

NCT07389096

Clinical

Trials by Indication[1]

Sedation14 trials

Combined Ketamine/Propofol for Emergency Department Procedural Sedation

Terminated·UUniversity of Missouri-Columbia·N/A·NCT01126957·107 enrolled

Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Completed·PPeking University·Phase 4·NCT04602845·81 enrolled

Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Completed·MMahidol University·Phase 4·NCT02733705·124 enrolled

Show 11 more trials

Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

Completed·MMansoura University·Phase 2·NCT05324891·40 enrolled

Prospective IR-led Sedation Feasibility

Recruiting·—·Phase 1/2·NCT07443254·40 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

Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Completed· Pfizer logo

Pfizer·Phase 4·NCT01519167·91 enrolled

BIS of Sedation Depth During Flexible Bronchoscopy.

Unknown status·NNanjing First Hospital, Nanjing Medical University·N/A·NCT03395093·500 enrolled

Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT02713191·197 enrolled

Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

Terminated·MMayo Clinic·Phase 4·NCT01195103·13 enrolled

Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients

Unknown status·QQilu Hospital of Shandong University·Phase 4·NCT02080169·600 enrolled

Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy

Unknown status·SShandong University·Phase 4·NCT03803449·500 enrolled

Sedation Strategies for Diagnostic Bronchoscopy 2

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

Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

Unknown status·—·N/A·NCT03235609·60 enrolled

Cancer Pain8 trials

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

Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

Completed·NNycomed·Phase 3·NCT00279344·220 enrolled

Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients

Completed·—··NCT06369961·151 enrolled

Show 5 more trials

Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

Completed·AArchimedes Development Ltd·Phase 3·NCT00459277·73 enrolled

Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain

Completed·AArchimedes Development Ltd·Phase 3·NCT00458510·403 enrolled

Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

Terminated·CCephalon·Phase 4·NCT00842829·330 enrolled

Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain

Unknown status·GGyeongsang National University Hospital·Phase 3·NCT02084355·136 enrolled

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

Fentanyl7 trials

Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl

Completed·DDepomed·Phase 4·NCT02470390·13 enrolled

Symptom-inhibited Fentanyl Induction

Completed·PPouya Azar·Phase 4·NCT05905367·48 enrolled

Staccato Fentanyl Single and Multidose PK

Completed·AAlexza Pharmaceuticals, Inc.·Phase 1·NCT00402350·51 enrolled

Show 4 more trials

Sublingual Fentanyl and Procedural Burn Pain

Terminated·LLoyola University·Phase 3·NCT02241486·2 enrolled

Fentanyl Sublingual Spray in Opioid Naive Participants

Completed·IINSYS Therapeutics Inc·Phase 1·NCT02641340·96 enrolled

RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain

Terminated·JJohns Hopkins University·Phase 4·NCT03305055·4 enrolled

Continuous Infusion of Fentanyl in Preterm on MV

Completed·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·Phase 3·NCT00571636·128 enrolled

Post Operative Pain5 trials

Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.

Not yet recruiting·—·Phase 2·NCT06531759·100 enrolled

The Effect of Choice of Intraoperative Opioid on Postoperative Pain

Completed·EEndeavor Health·Phase 4·NCT01542645·164 enrolled

Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain

Completed·—·Phase 4·NCT03199157·78 enrolled

Show 2 more trials

Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

Completed·—·Phase 4·NCT01114971·75 enrolled

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

Total Knee Arthroplasty5 trials

Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty

Completed·KKhon Kaen University·Phase 4·NCT01348984·40 enrolled

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

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

Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty

Completed·HHospital for Special Surgery, New York·Phase 4·NCT05980546·244 enrolled

Show 2 more trials

Implementation of a Pain Management Protocol for Total Knee Arthroplasty

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

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

Completed·—·Phase 4·NCT00562627·102 enrolled

115 more indications

Intravenous4 trials

Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

Completed·MM.D. Anderson Cancer Center·Phase 4·NCT02459964·84 enrolled

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

Recruiting·—·Phase 1·NCT07190625·75 enrolled

Determination of Analgesic Equipotent Doses of Inhaled Metoxyflurane vs. Intravenous Fentanyl

Completed·OOslo University Hospital·Phase 4·NCT03894800·12 enrolled

Show 1 more trial

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

Completed·IINSYS Therapeutics Inc·Phase 1·NCT01780233·40 enrolled

Breakthrough Pain4 trials

Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Completed·NNycomed·Phase 3·NCT00496392·115 enrolled

Fentanyl for Breakthrough Pain in the Emergency Department

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT01812759·3 enrolled

Sublingual Fentanyl for the Management of Breakthrough Pain

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02514252·6 enrolled

Show 1 more trial

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain

Completed·—·Phase 4·NCT01846221·101 enrolled

Delirium4 trials

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

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

Decreasing the Incidence of Delirium After Cardiac Surgery

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

Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)

Completed·UUniversity of Nairobi·N/A·NCT02753725·110 enrolled

Show 1 more trial

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

Perioperative Analgesia3 trials

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Completed·—·Phase 4·NCT00654511·101 enrolled

Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

Unknown status·—·Phase 4·NCT03393988·20 enrolled

Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties

Completed·DDhritiman Chakrabarti·Phase 4·NCT03667352·60 enrolled

Dexmedetomidine3 trials

Effect of Dexmedetomidine Upon Sleep Postoperatively

Withdrawn·—·Phase 4·NCT00333632

Effects of Dexmedetomidine on the Postoperative Experience in Children

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

Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

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

Pain Management3 trials

Pediatric Ketamine Study for Pain Management

Terminated·AAntonios Likourezos·Phase 4·NCT02388321·22 enrolled

A Comparison of Three Regimens of Acute Pain Management: Methoxyflurane; Intranasal Fentanyl; Intravenous Morphine

Completed·OOslo University Hospital·Phase 3·NCT05137184·338 enrolled

Intranasal Fentanyl for Pain Management

Unknown status·GGenesys·Phase 4·NCT00882960·500 enrolled

Mechanical Ventilation3 trials

Treatment of Procedural Pain Associated With Turning in Patients With Mechanical Ventilation

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT01950000·75 enrolled

Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT05201560·40 enrolled

Efficacy and Safety of Fentanyl for Pain Control in Newborn on Mechanical Ventilation

Unknown status·—·Phase 4·NCT04937946·40 enrolled

General Anesthesia3 trials

Evaluation of the Nociception Guided by NoL Index and PK of Fentanyl in Pediatric Patients Under General Anesthesia

Completed·PPontificia Universidad Catolica de Chile··NCT04786275·25 enrolled

Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

Completed·—·Phase 4·NCT03438240·80 enrolled

Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia

Unknown status·LLoyola University·Phase 2/3·NCT02489019·105 enrolled

Postoperative Pain Control3 trials

Post Operative Pain Control: Morphine vs Fentanyl

Completed·—·N/A·NCT02146638·60 enrolled

Post Operative Pain Control After Pediatric Hip Surgery

Terminated·SSeattle Children's Hospital·N/A·NCT03435692·42 enrolled

Post Operative Pain Control of POEM Procedure

Unknown status·CChen Wannan·Phase 4·NCT04177342·196 enrolled

Labor Analgesia3 trials

Comparison of PIEB vs CEI for Labor Analgesia

Completed·—·Phase 4·NCT02949271·179 enrolled

Epidural Fentanyl for 2nd Stage Labor Analgesia

Terminated·OOhio State University·Phase 4·NCT03120780·65 enrolled

Intrathecal Hydromorphone for Labor Analgesia

Terminated·—·N/A·NCT02277782·21 enrolled

Cardiac Surgery3 trials

Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery

Unknown status·MMansoura University·N/A·NCT04945694·80 enrolled

Measures to Lower the Stress Response in Pediatric Cardiac Surgery

Completed·NNationwide Children's Hospital·Phase 2·NCT00848393·52 enrolled

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

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

Opioid Free Anesthesia3 trials

Opioid Free Anesthesia Versus Opioid Based Anesthesia

Not yet recruiting·—·N/A·NCT06650371·36 enrolled

Opioid-free Anesthesia in Laparoscopic Cholecystectomies

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

Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

Completed·IIndonesia University·Phase 2/3·NCT06394375·74 enrolled

Cesarean Section3 trials

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

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

Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension

Completed·—·N/A·NCT02577432·124 enrolled

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

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

Osteoarthritis3 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

An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01795898·237 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

Abortion2 trials

Ketamine Versus Fentanyl for Surgical Abortions

Completed·UUniversity of Washington·Phase 4·NCT04871425·110 enrolled

Effect of Oxycodone on Anxiety State in Painless Abortion

Not yet recruiting·RRuijin Hospital·Phase 1·NCT06435949·300 enrolled

Spinal Anesthesia2 trials

Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Completed·—·Phase 4·NCT02862912·43 enrolled

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

Septic Shock2 trials

Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

Completed·—·Phase 4·NCT03251170·42 enrolled

Hemodynamic Effects of Bolus of Ketamine Versus Fentanyl in Patients With Septic Shock

Completed·—·N/A·NCT05957302·86 enrolled

Analgesia2 trials

Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Completed·FFederal University of São Paulo·Phase 3·NCT00713726·160 enrolled

Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope

Completed·AAzienda Sanitaria dell'Alto Adige·Phase 4·NCT03080350·108 enrolled

Efficacy and Safety2 trials

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

Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

Withdrawn·CCristália Produtos Químicos Farmacêuticos Ltda.·Phase 3·NCT00959400

Chronic pain2 trials

Matrifen® for Therapy of Severe Chronic Pain®

Completed·NNycomed··NCT00699335·5,308 enrolled

Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain

Completed·CCephalon·Phase 3·NCT00813488·213 enrolled

Erector Spinae Plane Block2 trials

Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection

Not yet recruiting·—·N/A·NCT06336161·80 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

Postoperative Analgesia2 trials

Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

Completed·KKhon Kaen University·N/A·NCT01726530·50 enrolled

Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine As a Postoperative Analgesia in Lower Limb Surgeries

Not yet recruiting·—·Phase 4·NCT06720506·100 enrolled

Laparoscopic Sleeve Gastrectomy2 trials

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Completed·MMedical University of Warsaw·Phase 4·NCT04260659·59 enrolled

Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy.

Not yet recruiting·—·N/A·NCT07246447·8 enrolled

Anesthesia2 trials

Opioid-Free vs Opioid-Based Anesthesia for Nasal Surgeries

Completed·—·Phase 3·NCT07350668·60 enrolled

Minimal Flow Anesthesia and Infection Risk

Active, not recruiting·—·N/A·NCT07092046·140 enrolled

Treatment2 trials

Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting

Withdrawn·IINSYS Therapeutics Inc·Phase 3·NCT02138409

Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room

Completed·AAzienda Sanitaria dell'Alto Adige·Phase 4·NCT03080324·108 enrolled

Hemodynamic2 trials

Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.

Recruiting·TTel-Aviv Sourasky Medical Center··NCT06966869·40 enrolled

Comparison of Fentanyl and Magnesium to Control Reflex Hemodynamics in Patients Aged 50 and Older

Completed·—·N/A·NCT07258628·76 enrolled

Bupivacaine2 trials

Minimum Effective Dose (MED) & Epidural Bupivacaine

Unknown status·UUniversity of Leeds·Phase 4·NCT02116842·100 enrolled

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

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

Renal Colic2 trials

Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic

Completed·IIsmail Tekin·Phase 4·NCT06558916·90 enrolled

Nasal Fentanyl And Renal Colic

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

Laparoscopic Cholecystectomy2 trials

Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine As Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy

Not yet recruiting·—·Phase 4·NCT06722963·70 enrolled

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Bronchoscopy1 trial

Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Withdrawn·—·Phase 4·NCT03613792

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

Lung Disease1 trial

Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients

Completed·NNazmy Edward Seif·N/A·NCT03324490·60 enrolled

Intensive Care Unit1 trial

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Completed· GSK logo

GSK·Phase 4·NCT00158873·224 enrolled

Hypotensive Anesthesia1 trial

Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation

Unknown status·MMansoura University·N/A·NCT05241054·64 enrolled

Severe Pain1 trial

Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients

Withdrawn·UUniversity of Utah·N/A·NCT01169025

Obese Patients1 trial

Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask

Withdrawn·MMontefiore Medical Center·N/A·NCT03009877

Hepatectomy1 trial

Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy

Completed·MMansoura University·N/A·NCT02531529·70 enrolled

Spine Surgery1 trial

Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index

Completed·MMahidol University·N/A·NCT02174913·34 enrolled

Dysphagia1 trial

Trial- Dysphagia From ETT or GI Endoscopy

Withdrawn·—·N/A·NCT02460055

Rocuronium1 trial

The Onset Time of Rocuronium in Emergency and Elective Surgery

Unknown status·—·Phase 3·NCT02634255·50 enrolled

Respiratory Depression1 trial

Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression

Terminated·UUniversity of Alabama at Birmingham··NCT03441282·26 enrolled

Abdominoplasty1 trial

Study in Subjects Undergoing Complete Abdominoplasty

Completed·CConcentric Analgesics·Phase 2·NCT03789318·54 enrolled

Aspiration1 trial

Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration

Terminated·SSt. Jude Children's Research Hospital·Phase 3·NCT00187135·168 enrolled

Postoperative Quality of Recovery1 trial

Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Unknown status·—·N/A·NCT02534623·70 enrolled

Lateral Femoral Cutaneous Nerve Block1 trial

Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries

Recruiting·KKasr El Aini Hospital·Phase 2·NCT06417268·68 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

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

Hemodynamic Stability1 trial

Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries

Completed·—·Phase 4·NCT06395727·106 enrolled

Adverse Events1 trial

Withdrawn·—·Phase 2·NCT03293927

Cognition1 trial

Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery

Completed·—·Phase 4·NCT01627873·622 enrolled

Orthopedic1 trial

Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00685295·60 enrolled

Complication1 trial

Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery

Completed·SSecond Affiliated Hospital of Nanchang University·N/A·NCT05527314·110 enrolled

Regional Anesthesia1 trial

Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction

Completed·VVanderbilt University Medical Center·N/A·NCT02584452·59 enrolled

Postoperative Recovery1 trial

Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Terminated·TThe Cleveland Clinic·Phase 4·NCT04561375·61 enrolled

Fractures1 trial

A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures.

Terminated·—·Phase 4·NCT02056288·78 enrolled

Procedural Pain1 trial

Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients

Completed·TTurku University Hospital·Phase 4·NCT01604187·158 enrolled

Cataract1 trial

Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

Not yet recruiting·IIstanbul University - Cerrahpasa·N/A·NCT07347886·120 enrolled

Neuropathic Pain1 trial

Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Completed·JJohns Hopkins University·N/A·NCT00181246·53 enrolled

Rheumatoid Arthritis1 trial

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00524160·264 enrolled

Fasting Conditions1 trial

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Completed·IINSYS Therapeutics Inc·N/A·NCT02138396·12 enrolled

Adolescent Idiopathic Scoliosis1 trial

Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis

Recruiting·NNashwa Ahmed·Phase 4·NCT07389096·30 enrolled

Radius Fracture1 trial

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures

Recruiting·SState University of New York at Buffalo·Phase 3·NCT07120763·50 enrolled

Neurodevelopment1 trial

The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

Completed·SStanford University·N/A·NCT03882788·153 enrolled

Emergency Department Patient1 trial

Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

Withdrawn·IINSYS Therapeutics Inc·Phase 2·NCT02137525

Virtual Reality1 trial

Coronary Angiography THerapeutic Virtual Reality

Withdrawn·UUniversity of California, Los Angeles·N/A·NCT03490903

Propofol1 trial

Combined Use of Etomidate and Propofol in Painless Gastroscopy.

Unknown status·JJiangsu Nhwa Pharmaceutical Co., Ltd.·Phase 4·NCT01913054·2,450 enrolled

Oral Mucositis1 trial

Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis

Completed·IINSYS Therapeutics Inc·Phase 3·NCT00956254·18 enrolled

Lidocaine1 trial

Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries

Not yet recruiting·—·Phase 4·NCT06696586·84 enrolled

Anxiety1 trial

Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain

Terminated·CCephalon·Phase 3·NCT00387010·218 enrolled

Inguinal hernia1 trial

Paravertebral Block for Inguinal Hernia Repair in Elderly

Completed·MMakassed General Hospital·N/A·NCT02537860·200 enrolled

Catheter1 trial

Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT02623959·3 enrolled

Dyspnea1 trial

Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

Completed·MM.D. Anderson Cancer Center·Phase 2/3·NCT02597478·50 enrolled

Abdominal Cancer Surgeries1 trial

Hemodynamic and Cardiac Effects of Dexmedetomidine Versus Fentanyl by Intravenous Infusion as Adjuncts to General Anesthesia in Patients Undergoing Major Abdominal Cancer Surgeries.

Not yet recruiting·—·Phase 4·NCT07214714·70 enrolled

Craniotomy1 trial

The Efficacy of Scalp Block in Craniotomy

Completed·—·Phase 1·NCT06951230·20 enrolled

Quality of Recovery1 trial

Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy

Not yet recruiting·—·N/A·NCT07262242·120 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

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

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

Opioid-induced Hyperalgesia1 trial

Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT02252458·21 enrolled

Nerve Block1 trial

Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery

Completed·UUniversity of Parma·Phase 4·NCT00724035·52 enrolled

Pediatric Patients1 trial

Cycling of Sedative Infusions in Critically Ill Pediatric Patients

Terminated·—·N/A·NCT01333059·25 enrolled

Hyperbaric Bupivacaine1 trial

Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Completed·—·N/A·NCT03415087·56 enrolled

Quadratus Lumborum Block1 trial

Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia

Completed·MMansoura University·N/A·NCT03323684·159 enrolled

Memory1 trial

Memory & Conditioning Under Anesthesia

Completed·KKeith M Vogt·Phase 1·NCT04062123·92 enrolled

Tics1 trial

Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

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

Nephrectomy1 trial

QLB After Nephrectomy

Completed·MMedical University of Lublin·N/A·NCT03529201·105 enrolled

Mastectomy1 trial

Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery

Completed·—·Phase 4·NCT05332028·64 enrolled

Platelet Reactivity1 trial

Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

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

Strabismus1 trial

Pain Medications in Children Undergoing Strabismus Surgery

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

Heart Failure1 trial

Mechanisms of Altered Ventilatory Control in Heart Failure

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

Vaginal Delivery1 trial

the Effects of Epidural Fentanyl on Vaginal Delivery

Unknown status·UUniversity of Athens·N/A·NCT02135224·60 enrolled

Drug1 trial

Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

Active, not recruiting·—·Phase 3·NCT07165262·88 enrolled

Major Depressive Disorder1 trial

Ketamine Co-induction for Patients With Major Depressive Disorder

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

After Cardiac Surgery1 trial

Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

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

Ketorolac1 trial

Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy

Not yet recruiting·UUniversity of South Alabama·Phase 4·NCT07276906·300 enrolled

Efficacy1 trial

Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Completed·HHospital Nossa Senhora da Conceicao·Phase 2/3·NCT03000413·45 enrolled

Extracorporeal Membrane Oxygenation1 trial

Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Recruiting·—··NCT03593408·20 enrolled

Breast Surgery1 trial

Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery

Unknown status·—·N/A·NCT03480308·1 enrolled

Agitation1 trial

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

Alpha-1 Antitrypsin Deficiency1 trial

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

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Multimodal Analgesia1 trial

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Completed·WWashington University School of Medicine·Phase 2·NCT03084536·134 enrolled

Renal Transplant1 trial

Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control

Completed·—·N/A·NCT02858622·44 enrolled

Surgery1 trial

Intrathecal Magnesium for Same-day-surgery

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

Chronic Obstructive Pulmonary Disease1 trial

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

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

Bariatric Surgery1 trial

Dexmedetomidine to Treat Bariatric Surgery-associated Pain

Completed·JJanelle Vaughns·Phase 3·NCT02880540·26 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

Oocyte Retrieval1 trial

A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

Completed·KKwong Wah Hospital·Phase 4·NCT02494180·170 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

Infusion1 trial

Determining the Prognostic Value of Continuous Intrathecal Infusion

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT03523000·36 enrolled

Painless Gastrointestinal Endoscopy1 trial

Effect of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy

Unknown status·—·N/A·NCT04691076·1,000 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

Lumbar Erector Spinae Plane Block1 trial

Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block

Completed·ZZagazig University·Phase 2·NCT04899388·69 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 — 524 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

8835459Jan 25, 2027

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9597288Jul 23, 2027

7862832Jun 15, 2028

7862833Jun 15, 2028

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