REMIFENTANIL HYDROCHLORIDE
Remifentanil hydrochloride is an intravenous medication used to provide pain relief during the start and continuation of general anesthesia for both inpatient and outpatient surgeries. It also helps adult patients manage pain immediately after surgery while they are under supervision in a recovery unit or intensive care setting. Additionally, it is used as a pain-relieving component for adults undergoing monitored anesthesia care.
How REMIFENTANIL HYDROCHLORIDE Works
This drug works by binding to μ-opioid receptors to provide rapid pain relief with a short duration of action. It is unique because it is quickly broken down by enzymes in the blood and tissues rather than plasma cholinesterase, which ensures a normal duration of action even in patients with atypical enzyme levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-01-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
REMIFENTANIL HYDROCHLORIDE Approval History
What REMIFENTANIL HYDROCHLORIDE Treats
1 indicationsREMIFENTANIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
REMIFENTANIL HYDROCHLORIDE Boxed Warning
ADDICTION, ABUSE, AND MISUSE Addiction, Abuse, and Misuse Remifentanil hydrochloride for 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 Remifentanil hydrochloride for injection [see Warnings and Precautions ( 5.1 )] . WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning . Remifentanil hydrochloride for injection expose...
WARNING: ADDICTION, ABUSE, AND MISUSE Addiction, Abuse, and Misuse Remifentanil hydrochloride for 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 Remifentanil hydrochloride for injection [see Warnings and Precautions ( 5.1 )] . WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning . Remifentanil hydrochloride for injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. ( 5.1 )
REMIFENTANIL HYDROCHLORIDE 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 REMIFENTANIL HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
115 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07556172 | IIT-I-2025-061 | Ph 4 | active not recruiting | Clinical Study of Esketamine in Patients With Sepsis Undergoing Invasive Mechanical Ventilation |
| NCT02029898 REAGI | 2012/175/HP 2013-001850-83 | Ph 1, Ph 2 | completed | Remifentanil for General Anesthesia in the Context of Immaturity |
| NCT04940689 OFACS | 2019/0399/HP 2020-002126-90 | Ph 3 | completed | Opioid-Free Anesthesia in Cardiac Surgery |
| NCT03812003 | 2-107-05-162 | Ph 4 | completed | Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia |
| NCT02527083 results posted | PRO00000878 | Ph 4 | completed | Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain |
| NCT06564857 ROCVIDEO | ROCVIDEO 2025-521405-40-01 | Ph 4 | recruiting | Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation |
| NCT03089905 TREX | TREX TRIAL 2024-512385-34-00 | Ph 3 | active not recruiting | A Study to Compare the Long-term Outcomes After Two Different Anaesthetics |
| NCT03066739 | 20141345 | Ph 2 | terminated | Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia |
| NCT06958393 | opioid-free anaesthesia | Ph 4 | not yet recruiting | Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery |
| NCT05391555 results posted | 21-34917 | Ph 2, Ph 3 | completed | Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age |
| NCT06793150 | AIBU-AR-GÇÖ-01 | Ph 4 | completed | Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries |
| NCT03864094 VH | 2019/374 2019-000965-19 | Ph 4 | completed | Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine. |
| NCT03283150 results posted | 2016-1420 A530900, SMPH\ANESTHESIOLOGY\ANESTHESIO | Ph 4 | terminated | Deep Brain Stimulation (DBS) Sedation |
| NCT06454292 | 2024-10 | Ph 4 | not yet recruiting | Efficacy and Safety Studies of Oliceridine Fumarate |
| NCT06444997 | B2024-161R | Ph 4 | not yet recruiting | Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients |
| NCT04204967 TOES | 2687 2019-002509-22 | Ph 2 | completed | Totally Transdermal Sedation in the Weaning From Remifentanil Infusion |
| NCT02631135 results posted | 2007-21/18 | Ph 4 | completed | Cognitive Functions After TIVA With Dexmedetomidine |
| NCT06403670 | NORADEX | Ph 4 | completed | Dexmedetomidine and Remifentanil in NORA |
| NCT03143972 PIRAD | PIRAD-001 | Ph 4 | completed | Pharmacodynamic Interaction of REMI and DMED |
| NCT05125328 | KMUHIRB-F(I)-20210156 | Ph 4 | completed | ANI and Remifentanil in Skull Pin Fixation. |
| NCT05782894 | WHUICU202208 | Ph 3 | completed | Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients |
| NCT02484859 results posted | 2015/14 | Ph 4 | completed | Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery |
| NCT02164734 results posted | 3768 | Ph 4 | terminated | Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome |
| NCT03643796 results posted | 207374 | Ph 4 | completed | Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery |
| NCT04670471 | CNS7056-025 2020-003806-30 | Ph 1 | completed | Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil |
| NCT03994146 | 2019-001677-81 | Ph 4 | terminated | Remifentanil Tapering and Post-adenotonsillectomy Pain in Children |
| NCT03613792 | 2018P000023 | Ph 4 | withdrawn | Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy |
| NCT01809041 | ZZuo-POCD-1 | Ph 4 | completed | Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction |
| NCT02822144 GASS | 35RC15_8957 2016-000795-25 | Ph 3 | completed | General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke |
| NCT02989597 MAPS results posted | 2016-6985 | Ph 4 | terminated | Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients |
| NCT05468671 | IRB-2020-406 | Ph 4 | completed | Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy |
| NCT03928366 | UNLOCK | Ph 1, Ph 2 | completed | Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses |
| NCT05215834 | WonkwangUH9 | Ph 4 | completed | The Comparison of Remimazolam With Propofol in Core Body Temperature |
| NCT02967029 | IstanbulUn | Ph 4 | completed | Effect of Controlled Hypotension on Cerebral Oxygen Saturation |
| NCT03905837 | IGMFGG-2016 | Ph 4 | completed | Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery |
| NCT02799589 Remi-dex | Pro00006472 | Ph 4 | withdrawn | Remifentanil-dexmedetomidine Anesthesia With a Caudal for Elective Surgery. (Remi-dex) |
| NCT03925779 | 2019/3/15/9 | Ph 2 | completed | Conscious Sedation for Outpatient Colonoscopy |
| NCT02664922 results posted | Anes Tech 11-003514 | Ph 4 | terminated | Anesthetic Techniques in EP Patients |
| NCT02486328 results posted | UfukU | Ph 4 | completed | The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy |
| NCT02379715 | AJIRB-MED-CT4-14-327 | Ph 4 | completed | Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane |
| NCT02206022 REMIDOLCATH | 13 6932 03 | Ph 4 | completed | Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters |
| NCT02349152 results posted | PRO14110258 | Ph 4 | completed | Remifentanil and Glycemic Response in Cardiac Surgery |
| NCT01152515 results posted | IRB 4-2010-0022 | Ph 4 | completed | A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients |
| NCT02473354 (OIRD) | Pro00060429 | Ph 1 | completed | Predictors of Opioid-Induced Respiratory Depression (OIRD) |
| NCT01937767 | CNS7056-010 2013-001113-32 | Ph 2 | completed | Remimazolam Phase II Cardiac Anesthesia Study |
| NCT04026074 | 2 | Ph 4 | completed | Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations. |
| NCT03316339 POFA | 35RC16_9842_POFA | Ph 3 | terminated | Postoperative and Opioid Free Anesthesia |
| NCT03330782 | AJIRB-MED-OBS-17-197 | Ph 4 | completed | Remifentanil for Preventing Propofol Injection Pain in Elderly Patients |
| NCT03901716 | Opioid2019 | Ph 4 | completed | Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation |
| NCT02655380 | MED-DRU-15-354 | Ph 4 | completed | Remifentanil Requirement for Acceptable Intubating Condition |
Showing 50 of 115 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.
REMIFENTANIL HYDROCHLORIDE FDA Label Details
Indications & Usage
REMIFENTANIL HYDROCHLORIDE is indicated for the treatment of Pain.
WARNING: ADDICTION, ABUSE, AND MISUSE Addiction, Abuse, and Misuse Remifentanil hydrochloride for 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 Remifentanil hydroch...
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ULTIVA
Full clinical data, patents, trials, and competitive landscape for remifentanil hydrochloride.
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