FENTANYL-37 (fentanyl)
Fentanyl-37 is indicated for short-duration analgesia during the perioperative period, including premedication, induction, maintenance, and immediate postoperative recovery. It is used as a narcotic analgesic supplement in general or regional anesthesia and can be administered in combination with a neuroleptic. Additionally, it serves as a primary anesthetic agent with oxygen for selected high-risk patients undergoing complex surgical procedures, such as open-heart surgery or complicated neurological and orthopedic procedures.
How FENTANYL-37 Works
Fentanyl-37 functions as an opioid agonist. Its principal therapeutic effects are the provision of dose-related analgesia and sedation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-01-28
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
FENTANYL-37 Approval History
What FENTANYL-37 Treats
4 indicationsFENTANYL-37 is approved for 4 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Short-term pain during anesthesia periods
- Postoperative pain in the recovery room
- General or regional anesthesia supplementation
- High-risk surgical anesthesia (e.g., open heart, neurological, or orthopedic surgery)
FENTANYL-37 Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Fentanyl Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, l...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Fentanyl Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential [see Warnings and Precautions ( 5.2 )]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Fentanyl Citrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. Cytochrome P450 3A4 Interaction The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )] WARNING: SERIOUS AND LIFE-THREATENING RISKS FR
FENTANYL-37 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FENTANYL-37
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
204 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07556523 | IRB2025-0154 | Ph 4 | recruiting | Patient Quality of Recovery After TAVR With Different Sedation Regimens |
| NCT07224620 FenHydro | 2025P000456 | Ph 2 | recruiting | Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation |
| NCT06868589 RELIEF-LT | 20243140 | Ph 4 | active not recruiting | Reducing Pain With Methadone and Ketamine in Liver Transplant |
| NCT07459166 | CS-1103-03 5UG3DA059286 | Ph 2 | not yet recruiting | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| NCT06867068 | 2014-3556 | Ph 1 | completed | Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery |
| NCT05905367 SIFI | H23-00111 | Ph 4 | completed | Symptom-inhibited Fentanyl Induction |
| NCT06784180 | 23-3302 | Ph 4 | withdrawn | Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine |
| NCT06772727 | MD-265-2024 | Ph 4 | completed | Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy |
| NCT03214510 | 2016-1111 NCI-2018-01124, 2016-1111 | Ph 3 | active not recruiting | Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery |
| NCT07443085 | RC24/2/2026 | Ph 2 | recruiting | Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery |
| NCT07435337 | RIC/RERC/29/26 | Ph 4 | recruiting | Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy |
| NCT03476369 FACTPCI results posted | 1801-05 | Ph 4 | terminated | Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention |
| NCT07078201 | IRB00012098- Serial0307331 | Ph 4 | recruiting | Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl |
| NCT07276906 NOA | 2387143-1 | Ph 4 | not yet recruiting | Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy |
| NCT07238101 | 216 /KEPK/USU/2024 | Ph 4 | completed | Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery |
| NCT03726268 OSPREy results posted | Pro00089977 1R01DA042985-01 | Ph 4 | completed | Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) |
| NCT05980546 | 2023-0063 | Ph 4 | completed | Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty |
| NCT06479655 | USM/JEPeM/KK/24010062 | Ph 4 | recruiting | Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients |
| NCT06395727 hemodynamics | FMASU R57/2024 | Ph 4 | completed | Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries |
| NCT07148882 | MS683/2023 | Ph 2, Ph 3 | completed | Pain Managment in Preterm Neonates |
| NCT06823349 SSSA | Asw.Uni. / 926 / 5 / 24 | Ph 4 | recruiting | Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor |
| NCT06763705 | 607/45/15284 | Ph 4 | recruiting | Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy |
| NCT07035223 | KFSIRB200-594 | Ph 4 | completed | 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 |
| NCT06364540 KETAFEN | 2023-08-14 | Ph 4 | recruiting | Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED |
| NCT03834363 MoreFoRCOPD | MoreFoRCOPD | Ph 4 | completed | Morphine or Fentanyl for Refractory Dyspnea in COPD |
| NCT05367336 results posted | EGME#04-2021 | Ph 2 | terminated | Platelet Reactivity With Fentanyl, Morphine, or no Narcotic |
| NCT05487196 results posted | STUDY22030095 | Ph 2 | completed | Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia |
| NCT04062123 MCA results posted | STUDY19030183 R35GM146822 | Ph 1 | completed | Memory & Conditioning Under Anesthesia |
| NCT03167905 CODEPAD | 2017/2090 | Ph 2, Ph 3 | active not recruiting | CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery) |
| NCT06590870 INFENT PICC | 24-0072-A 46585 | Ph 3 | completed | Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement |
| NCT06834854 | FMASU MS149/2024 | Ph 1 | completed | Opioid Free Anesthesia in Shoulder Arthroscope |
| NCT06502262 | MS 571/2023 | Ph 1 | completed | A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture |
| NCT02617758 | CR108059 FENPAI1023 | Ph 1 | completed | Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants |
| NCT06799442 DEX/Fentanyl | DEX/Fentanyl ESPB Nephrectomy | Ph 2, Ph 3 | not yet recruiting | Dexmedetomidine Versus Fentanyl as Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: A Randomized Clinical Trial |
| NCT03084536 results posted | 201703053 | Ph 2 | completed | PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery |
| NCT04528173 results posted | 19-016618 | Ph 4 | terminated | Opioid-Free Anesthetic for Tonsillectomy |
| NCT06722963 | fentanyl vs nalbuphine cholecy | Ph 4 | not yet recruiting | Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine as Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy |
| NCT06720506 | fentanyl Vs nalbuphine LL surg | Ph 4 | not yet recruiting | Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine as a Postoperative Analgesia in Lower Limb Surgeries |
| NCT06318546 | FMASU MS59/2024 | Ph 1 | completed | Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section |
| NCT06630364 KVFPT | E-10840098-772.02-4354Karar651 Istanbul Medipol University | Ph 4 | completed | Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT) |
| NCT06636578 | R 611 | Ph 4 | recruiting | Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block |
| NCT02278601 COLEUS | CTGL13feb013 | Ph 3 | active not recruiting | Comparison of Regimens MPIB, CIPCEA, PCEA |
| NCT04011150 VVAMB | AM/CT001/2018 | Ph 3 | recruiting | Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour |
| NCT06557473 | PT (812) | Ph 4 | completed | Lidocaine Versus Fentanyl for Hemodynamic Stability |
| NCT06558916 | ErciyesUniversity-IT01 | Ph 4 | completed | Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic |
| NCT06531759 | Pain after nasal surgeries | Ph 2 | not yet recruiting | Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries. |
| NCT06498037 FERRARI | 2023-507355-30 | Ph 4 | recruiting | Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn. |
| NCT03000413 MACANUDO | 42324015.0.0000.5530 | Ph 2, Ph 3 | completed | Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial |
| NCT06417268 | MD-16-2024 | Ph 2 | recruiting | Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries |
| NCT06394375 | IndonesiaU23061029 | Ph 2, Ph 3 | completed | Opioid Free Anesthesia in Abdominal Laparoscopic Surgery |
Showing 50 of 204 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FENTANYL-37 FDA Label Details
Indications & Usage
FENTANYL-37 is indicated for the treatment of Short-term pain during anesthesia periods; Postoperative pain in the recovery room; General or regional anesthesia supplementation; High-risk surgical anesthesia (e.g., open heart, neurological, or orthopedic surgery).
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Fentanyl Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment