Sufenta

(Sufentanil)

ApprovedSmall molecule

Sufentanil is a powerful painkiller used to manage severe pain, particularly after surgery or for cancer patients, and it's also used during anesthesia to keep patients comfortable during medical procedures.[2] Sufenta is currently approved and in use across 34 indications[4].[1]

Sufenta is one of 362 small molecule programs targeting Loss of consciousness. It is currently in Approved.

Indications

150

Total Trials

Active Trials

361

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Loss of ConsciousnessActive, not recruiting

Pain AgnosiaActive, not recruiting

Aortic AneurysmActive, not recruiting

Moyamoya DiseaseActive, not recruiting

AnxietyActive, not recruiting

General AnestheticRecruiting

Chronic Post-Surgical PainEnrolling by invitation

HysteroscopyCompleted

Biliary Tract DiseaseNot yet recruiting

DeliriumActive, not recruiting

Loss of ConsciousnessPreclinical

Active, not recruiting

Pain AgnosiaApproved

Active, not recruiting

Aortic AneurysmPreclinical

Active, not recruiting

Moyamoya DiseasePreclinical

Active, not recruiting

AnxietyPreclinical

Active, not recruiting

General AnestheticPreclinical

Recruiting

Chronic Post-Surgical PainApproved

Enrolling by invitation

HysteroscopyPreclinical

Completed

Biliary Tract DiseasePreclinical

Not yet recruiting

DeliriumApproved

Active, not recruiting

Showing 10 of 27 indications

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Sufenta

LLeaf Vertical Inc.

Approved

2 2

Ibrance

Pfizer

Preclinical

1 3

Sovaldi

Gilead

Preclinical

1 4

Cysteine Hydrochloride

Novartis

Preclinical

1 5

Hepsera

Coreg

2 7

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 8

Vermox

WWim Janssens

Preclinical

1 9

Valemetostat

Bristol-Myers Squibb

Preclinical

1 10

Statin

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Postoperative Analgesia

NCT06990893

PreclinicalRecruiting

General Anesthetic

NCT07323043

N/ARecruiting

Intraoperative

NCT06091904

Post-ApprovalRecruiting

Surgery

NCT06037330

Post-ApprovalActive, not recruiting

Anesthesia

NCT00577200

N/ANot yet recruiting

Nerve Block

NCT07386626

Clinical

Trials by Indication[1]

Dexmedetomidine5 trials

Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery

Unknown status·FFirst Affiliated Hospital, Sun Yat-Sen University·Phase 4·NCT02552459·120 enrolled

Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Completed·PPeking University First Hospital·Phase 4·NCT05698407·200 enrolled

Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia

Completed·TTianjin Medical University General Hospital·N/A·NCT03096730·150 enrolled

Show 2 more trials

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Recruiting·—·N/A·NCT06082856·594 enrolled

Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes

Completed·PPeking University First Hospital·Phase 4·NCT05718544·199 enrolled

Postoperative Analgesia5 trials

Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia

Completed·PPeking University First Hospital·Phase 4·NCT04791059·200 enrolled

The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil

Unknown status·HHuazhong University of Science and Technology·Phase 4·NCT03135795·100 enrolled

Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction

Recruiting·IIndiana University·Phase 4·NCT06784999·128 enrolled

Show 2 more trials

Postoperative Analgesia in Patients With Microvascular Decompression

Unknown status·XXiangya Hospital of Central South University·Phase 4·NCT03152955·90 enrolled

Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

Recruiting·—·N/A·NCT06990893·90 enrolled

Labor Analgesia5 trials

Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome

Withdrawn·—·Phase 3·NCT02857465

Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

Completed·MMaternal and Child Health Hospital of Hubei Province·Phase 2·NCT05901441·240 enrolled

PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous

Completed·UUniversity Hospital, Montpellier·N/A·NCT01856166·304 enrolled

Show 2 more trials

PIEB vs CEI for Labor Analgesia: An MLAC Study

Terminated·SStanford University·Phase 4·NCT02573597·31 enrolled

Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

Terminated·UUniversity of Modena and Reggio Emilia·N/A·NCT02710877·671 enrolled

Sedation5 trials

Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP

Not yet recruiting·TThe First Affiliated Hospital of Xinxiang Medical College·N/A·NCT07376577·141 enrolled

A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.

Terminated· GSK logo

GSK·Phase 4·NCT00421720·164 enrolled

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

Show 2 more trials

Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

Unknown status·PPeking University·N/A·NCT04924621·42 enrolled

Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study

Completed·GGuangzhou Institute of Respiratory Disease··NCT03890094·11,158 enrolled

Epidural Analgesia4 trials

Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

Unknown status·—·Phase 4·NCT03018171·268 enrolled

Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Unknown status·OOspedale San Raffaele·N/A·NCT02647047·40 enrolled

Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Terminated·HHopital Foch·N/A·NCT01505283·42 enrolled

Show 1 more trial

Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

Unknown status·NNanjing Maternity and Child Health Care Hospital·N/A·NCT02873091·186 enrolled

99 more indications

Anesthesia4 trials

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

Completed·—·Phase 4·NCT03726268·907 enrolled

Safety of Driving After Minor Surgery With Monitored Anesthesia Care

Active, not recruiting·RRush University Medical Center·Phase 4·NCT00577200·625 enrolled

Sufentanil as Adjuvant of Balanced Anesthesia

Completed·KKangbuk Samsung Hospital·N/A·NCT03868111·66 enrolled

Show 1 more trial

Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

Completed·CChina International Neuroscience Institution·Phase 4·NCT04443946·50 enrolled

Post Operative Pain3 trials

Effect of Sufentanil on the Postoperative Pain

Not yet recruiting·SSeoul National University Hospital·N/A·NCT06260046·48 enrolled

A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

Completed·TTalphera, Inc·Phase 3·NCT02356588·161 enrolled

A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

Completed·TTalphera, Inc·Phase 3·NCT02662556·140 enrolled

Intravenous3 trials

Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Terminated·HHopital Foch·Phase 4·NCT01320475·2 enrolled

Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

Unknown status·—·Phase 4·NCT03224039·40 enrolled

Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting

Completed·UUniversity Hospital, Grenoble·Phase 4·NCT02095366·194 enrolled

Delirium3 trials

Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery

Unknown status·XXiangya Hospital of Central South University·Phase 1·NCT03763084·164 enrolled

Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery

Not yet recruiting·QQianfoshan Hospital·Phase 4·NCT06958393·406 enrolled

Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

Completed·—·N/A·NCT06382961·287 enrolled

Analgesia3 trials

The Efficacy and Optimal Dose of Sufentanil in Patient Controlled Analgesia After Moderate Surgery

Unknown status·SSecond Affiliated Hospital of Xi'an Jiaotong University·Phase 4·NCT02503826·60 enrolled

Analgesia Effects of Nalbuphine vs Sulfentanil

Unknown status·FFudan University·N/A·NCT02604797·80 enrolled

Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06181695·182 enrolled

Total Knee Arthroplasty3 trials

Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)

Unknown status·MMore Foundation·Phase 4·NCT05307341·100 enrolled

Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

Completed·—·N/A·NCT04448457·72 enrolled

Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty

Completed·UUniversity Hospital, Ghent·Phase 4·NCT04432428·90 enrolled

Enhanced Recovery After Surgery2 trials

Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population

Withdrawn·WWest Virginia University·Phase 4·NCT04464512

The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Completed·—·N/A·NCT04048070·55 enrolled

Bronchoscopy2 trials

Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy

Completed·GGuangzhou Institute of Respiratory Disease·N/A·NCT03738137·80 enrolled

Efficacy and Safety of Cyclopofol Versus Propofol Combined With Low-dose Sufentanil in Painless Bronchoscopy

Completed·WWenzhou Central Hospital·Approved·NCT07744061·100 enrolled

Hepatocellular Carcinoma2 trials

Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma

Unknown status·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05670561·60 enrolled

Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma

Unknown status·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05416073·70 enrolled

Intraoperative2 trials

Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Completed·HHopital Foch·Phase 4·NCT00772616·60 enrolled

Effects of Sufentanil on the Intraoperative Hemodynamics

Recruiting·SSeoul National University Hospital·N/A·NCT06091904·92 enrolled

Brain Injury2 trials

Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury

Completed·UUniversitas Jenderal Soedirman·N/A·NCT07244822·28 enrolled

Ketamine and Glutamate After Brain Injury : a Microdialysis Study

Unknown status·PPierre-Julien CUNGI·Phase 2·NCT02232347·20 enrolled

General Anesthesia2 trials

Neuronal Mechanisms of Sensory Processing During General Anesthesia

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

Cardiac Index and General Anesthesia Without Opioid.

Completed·—·Phase 2/3·NCT05446623·120 enrolled

Hemodynamic Stability2 trials

Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients

Completed·SSeoul National University Hospital·N/A·NCT05423951·106 enrolled

Subanesthetic Esketamine for Hemodynamic Stability and Recovery in Elderly Thoracic Surgery Patients

Completed·HHebei Medical University Fourth Hospital·N/A·NCT07064408·230 enrolled

Nausea and vomiting2 trials

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

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

Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

Recruiting·YYanYing Xiao·Phase 4·NCT07026162·96 enrolled

Anesthesia Induction2 trials

Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Completed·UUniversity of Sao Paulo·Phase 4·NCT01777100·40 enrolled

The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study

Recruiting·PPeking University Shenzhen Hospital·N/A·NCT07089173·99 enrolled

Hyperalgesia2 trials

Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients

Completed·TTianjin Medical University General Hospital·N/A·NCT02043366·180 enrolled

Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area and Plateau Area

Unknown status·TTianjin Medical University General Hospital··NCT05028049·160 enrolled

Infusion2 trials

Sufentanil Infusion vs Sufentanil Bolus

Completed·UUniversity of Nebraska·Phase 4·NCT04226495·65 enrolled

the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

Completed·JJun Wang·Phase 4·NCT04111328·600 enrolled

Ambulatory Surgery2 trials

Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center

Completed·UUniversity of Minnesota·Phase 4·NCT04177862·75 enrolled

Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Completed·UUniversity of Minnesota·Phase 4·NCT04387136·53 enrolled

Pruritus1 trial

Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

Completed·TTongji Hospital·N/A·NCT07092384·265 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

Unknown status·MMaternal and Child Health Hospital of Hubei Province·Phase 2·NCT06036797·240 enrolled

Cognitive Function1 trial

Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.

Completed·—·Phase 4·NCT02053818·60 enrolled

Tics1 trial

Sufentanil Pharmacokinetics After Intra Amniotic Injection

Completed·UUniversity Hospital, Lille·Phase 2·NCT02962830·8 enrolled

Agitation1 trial

Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery

Unknown status·SSecond Affiliated Hospital of Nanchang University·Phase 4·NCT05624424·1,317 enrolled

Hemorrhage1 trial

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

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT04959812·46 enrolled

Elderly Patients1 trial

Etomidate to Improve Outcome in Elderly Patients

Completed·ZZhihong LU·N/A·NCT02910206·1,917 enrolled

Mechanically Ventilated Patients1 trial

Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients

Completed·UUniversity Hospital, Toulouse·Phase 4·NCT01356732·25 enrolled

Cerebral Perfusion1 trial

The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion

Completed·—··NCT00494598·6 enrolled

Total Hip Arthroplasty1 trial

Opioid Free Anesthesia in Total Hip Arthroplasty

Completed·CCMC Ambroise Paré·Phase 3·NCT05072704·80 enrolled

Nausea1 trial

Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

Not yet recruiting·XXuanwu Hospital, Beijing·N/A·NCT07479446·174 enrolled

Lung Cancer1 trial

Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer

Unknown status·QQianfoshan Hospital·Phase 1·NCT05742256·159 enrolled

Motion Sickness1 trial

Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

Completed·SSecond Hospital of Jilin University·Phase 4·NCT06232785·66 enrolled

Remimazolam1 trial

Varied Remimazolam Dosages for Pediatric Endoscopy

Completed·—·N/A·NCT07083440·180 enrolled

Hemodynamic1 trial

The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Completed·UUniversity Hospital, Lille·N/A·NCT03185403·54 enrolled

Not yet recruiting·—·Phase 1·NCT06570538·140 enrolled

Surgery1 trial

Nalbuphine in ARDS Patients After Surgery

Recruiting·HHairong Chen·Phase 4·NCT06037330·60 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy

Not yet recruiting·IIVO JURISIC·N/A·NCT07084753·36 enrolled

Children1 trial

Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

Completed·UUniversity Hospital, Grenoble·Phase 3·NCT01235637·40 enrolled

Randomised Controlled Trial1 trial

Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial

Completed·—·N/A·NCT07372209·120 enrolled

Anxiety1 trial

Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval

Completed·CCMC Ambroise Paré·N/A·NCT04213781·36 enrolled

Regional Anesthesia1 trial

Regional Anesthesia Versus General Anesthesia

Completed·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·N/A·NCT03830086·28 enrolled

Chronic pain1 trial

A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer

Withdrawn·LLabtec GmbH·Phase 2·NCT00943566

Postpartum Depression1 trial

Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients

Recruiting·WWomen's Hospital School Of Medicine Zhejiang University·Phase 4·NCT05826327·364 enrolled

Bupivacaine1 trial

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

Completed·—·Phase 2·NCT02430090·45 enrolled

Inflammatory Response1 trial

The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE

Completed·TThe First Affiliated Hospital with Nanjing Medical University·Phase 4·NCT06041425·40 enrolled

Quality of Recovery1 trial

Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection

Completed·FFujian Provincial Hospital·Phase 4·NCT05750056·234 enrolled

Pregnancy1 trial

Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)

Completed·UUniversity Hospital, Limoges·Phase 3·NCT02563821·37 enrolled

Oxycodone1 trial

Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone

Completed·PPeking University People's Hospital·Phase 4·NCT04396587·80 enrolled

Pain1 trial

Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay

Completed·—·Phase 4·NCT01954368·144 enrolled

Spinal Anesthesia1 trial

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

Double-blind1 trial

A Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT00656773·108 enrolled

Elderly1 trial

Sufentanil Bispectral Index Elderly

Completed·UUniversity Hospital, Geneva·N/A·NCT02831101·71 enrolled

Opioids1 trial

Impact of Opioids on Heart Rate During Rapid Sequence Intubation

Terminated·—·N/A·NCT05384665·3 enrolled

Cesarean Delivery1 trial

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Completed·—·Phase 2·NCT03036384·40 enrolled

Spinal Fusion1 trial

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

Terminated·MMontefiore Medical Center·Phase 4·NCT02989597·10 enrolled

Cesarean Section1 trial

Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section

Unknown status·MMakassed General Hospital·N/A·NCT04446715·60 enrolled

Coronary Artery Bypass1 trial

The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting

Unknown status·HHuazhong University of Science and Technology·Phase 4·NCT02213718·60 enrolled

Injury1 trial

Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery

Completed·KKonkuk University Medical Center·N/A·NCT02499445·120 enrolled

Sevoflurane1 trial

Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

Completed·UUniversity Hospital Schleswig-Holstein·N/A·NCT01525537·82 enrolled

Lumbar Erector Spinae Plane Block1 trial

Lumbar Erector Spinae Plane Block for Back Surgery

Unknown status·DDr M. B. Breebaart·Phase 3·NCT03825198·80 enrolled

Thoracic Surgery1 trial

Esketamine Anesthesia in Thoracic Surgery

Completed·HHui Xu·N/A·NCT06310785·84 enrolled

Opioid Free Anesthesia1 trial

Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT05242081·980 enrolled

Randomized Controlled Trial1 trial

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

Completed·GGZA Ziekenhuizen Campus Sint-Augustinus·Phase 4·NCT02544282·140 enrolled

Heart Disease1 trial

Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery

Completed·SShengjing Hospital·N/A·NCT04121416·50 enrolled

Efficacy1 trial

Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001

Completed·CCessatech A/S·Phase 2/3·NCT05508594·220 enrolled

Patient-controlled Intravenous Analgesia1 trial

Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery

Completed·XXijing Hospital·Phase 3·NCT05576675·4,342 enrolled

Knee Replacement Surgery1 trial

Analgesia After Total Knee Replacement Surgery

Completed·SSt. Antonius Hospital·N/A·NCT01489631·81 enrolled

Nerve Block1 trial

Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

Not yet recruiting·TTongji Hospital·N/A·NCT07386626·118 enrolled

Severe Pain1 trial

A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain

Terminated·UUniversity of Utah·Phase 1/2·NCT01012999·16 enrolled

Laparoscopic Surgery1 trial

Laparoscopic Surgery and Abdominal Compliance

Unknown status·CCHU de Reims·Phase 4·NCT02816567·180 enrolled

Postoperative Recovery1 trial

Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

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

Major Abdominal Surgery1 trial

A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

Completed·TTalphera, Inc·Phase 2·NCT00718081·88 enrolled

Local Anesthetic1 trial

Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

Completed·NNanjing Medical University·Phase 4·NCT02036242·500 enrolled

Tracheal Intubation1 trial

Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis

Not yet recruiting·UUniversity Hospital, Limoges·Phase 4·NCT07019818·120 enrolled

Trial1 trial

DSUVIA Early Evaluation of Pain Trial

Completed·FFrank Guyette·Phase 3·NCT05288348·150 enrolled

Patient-Controlled Analgesia1 trial

The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy

Completed·EEye & ENT Hospital of Fudan University·N/A·NCT06000137·129 enrolled

Safety and Efficacy1 trial

Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

Completed·TTalphera, Inc·Phase 3·NCT02447848·76 enrolled

Gynecologic Laparoscopic Surgery1 trial

Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia

Completed·PPeking University First Hospital·N/A·NCT01917045·180 enrolled

Trauma1 trial

Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.

Recruiting·UUniversity Hospital, Clermont-Ferrand·Phase 3·NCT06917651·300 enrolled

Recovery Quality1 trial

Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Completed·TTongji Hospital·N/A·NCT04067648·90 enrolled

Lower Extremity Fracture1 trial

Sufentanil in Patients With Lower Extremity Fracture Surgery Myocardial Damage Function Study

Not yet recruiting·SSecond Hospital of Shanxi Medical University·N/A·NCT06808841·160 enrolled

POI1 trial

The Effect and Safety of the Four Points Transversus Abdominis Plane Block

Completed·GGia Dinh People Hospital·N/A·NCT03598192·30 enrolled

Moyamoya disease1 trial

Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease

Unknown status·SSeoul National University Hospital·N/A·NCT05672212·40 enrolled

Prospective1 trial

Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial

Completed·HHospices Civils de Lyon·Phase 3·NCT00437996·85 enrolled

Observational Study1 trial

Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump (PCA=Patient Controlled Analgesia)) After Urogenital Intervention at the Clinical Daily Routine

Unknown status·UUniversity Hospital Tuebingen··NCT03355352·100 enrolled

Remifentanil1 trial

Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil

Unknown status·UUniversity Medical Center Groningen·N/A·NCT01871935·70 enrolled

Epidural1 trial

Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Unknown status·MMedical University of Warsaw·Phase 4·NCT03344042·300 enrolled

Hypoxemia During Surgery1 trial

Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial

Completed·SShiyou Wei·Preclinical·NCT07187765·508 enrolled

Chronic Post-surgical Pain1 trial

Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol

Recruiting·TTianjin Medical University General Hospital·Approved·NCT07018375·320 enrolled

Obstructive Sleep Apnea1 trial

Effects of Oliceridine Versus Sufentanil Analgesia on Incidence of Postoperative Respiratory Depression in Patients at High-Risk of Obstructive Sleep Apnea: A Prospective Cohort Study

Not yet recruiting·PPeking University First Hospital··NCT07753785·851 enrolled

Oliceridine Fumarate1 trial

Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study

Recruiting·XXijing Hospital·Preclinical·NCT07307495·428 enrolled

Hemodynamic Instability1 trial

Efficacy and Hemodynamic Safety of Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction: A Prospective Non-randomized Interventional Study

Completed·AAoyang Hospital Affiliated to Jiangsu University·Preclinical·NCT07730918·172 enrolled

Cough1 trial

Oliceridine vs Sufentanil for Cough During General Anesthesia Induction: A Randomized Controlled Trial

Recruiting·SShiyou Wei·Approved·NCT07660380·62 enrolled

Hysteroscopy1 trial

Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures

Completed·TTangshan Maternal and Child Health Hospital·Preclinical·NCT07713134·225 enrolled

Biliary Tract Disease1 trial

Effects of Esketamine-Propofol Versus Sufentanil-Propofol Sedation on Hypoxemia and Hypotension During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Not yet recruiting·RRen Da·Preclinical·NCT07702240·530 enrolled

General Anesthetic1 trial

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Recruiting·TThe First People's Hospital of Lianyungang·Preclinical·NCT07323043·190 enrolled

Sickle Cell Crisis1 trial

Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

Terminated·UUniversity Hospital, Bordeaux·Phase 3·NCT04076748·115 enrolled

Unspecified3 trials

Study of CT001 in Healthy Volunteers

Completed·CCessatech A/S·Phase 1·NCT04807335·14 enrolled

Sufentanil Intranasal

Unknown status·—·Phase 4·NCT04137198·170 enrolled

DSUVIA in Patients With SCD VOC Present in the ED

Unknown status·JJason Wilson··NCT05388188·100 enrolled

Regulatory

FDA Approval Timeline[5]

May 4, 1984

SUFENTA PRESERVATIVE FREE

NDA NDA019050

Nov 2, 2018

DSUVIA

NDA NDA209128

Sources

References

[1]
ClinicalTrials.gov — 150 trial records for Sufentanil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sufenta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sufentanil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sufentanil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209128). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sufenta. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Leaf Vertical Inc. 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: LLeaf Vertical Inc.

Patent Landscape[6]

Patent Cliff

Jan 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8778393Jan 5, 2027

9320710Jan 5, 2027

10507180Jan 5, 2027

8535714Jan 5, 2027

8778394Jan 5, 2027

16 more patents

9744129Jan 5, 2027

8252329Jan 5, 2027

10342762Jan 5, 2027

8252328Jan 5, 2027

8231900Jan 5, 2027

8226978Jan 5, 2027

8865211Jan 5, 2027

10245228Jan 5, 2027

12033733Mar 16, 2030

8574189Mar 16, 2030

10896751Mar 16, 2030

11676691Mar 16, 2030

8202535Oct 22, 2030

8865743Oct 22, 2030

8945592Jul 29, 2031

11672738Feb 2, 2038

Sufenta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Dexmedetomidine5 trials

Postoperative Analgesia5 trials

Labor Analgesia5 trials

Sedation5 trials

Epidural Analgesia4 trials

Anesthesia4 trials

Post Operative Pain3 trials

Intravenous3 trials

Delirium3 trials

Analgesia3 trials

Total Knee Arthroplasty3 trials

Enhanced Recovery After Surgery2 trials

Bronchoscopy2 trials

Hepatocellular Carcinoma2 trials

Intraoperative2 trials

Brain Injury2 trials

General Anesthesia2 trials

Hemodynamic Stability2 trials

Nausea and vomiting2 trials

Anesthesia Induction2 trials

Hyperalgesia2 trials

Infusion2 trials

Ambulatory Surgery2 trials

Pruritus1 trial

Efficacy and Safety1 trial

Cognitive Function1 trial

Tics1 trial

Agitation1 trial

Hemorrhage1 trial

Elderly Patients1 trial

Mechanically Ventilated Patients1 trial

Cerebral Perfusion1 trial

Total Hip Arthroplasty1 trial

Nausea1 trial

Lung Cancer1 trial

Motion Sickness1 trial

Remimazolam1 trial

Hemodynamic1 trial

Target Controlled Infusion of Propofol1 trial

Caesarean Section1 trial

Postoperative Pain Management1 trial

Surgery1 trial

Laparoscopic Sleeve Gastrectomy1 trial

Children1 trial

Randomised Controlled Trial1 trial

Anxiety1 trial

Regional Anesthesia1 trial

Chronic pain1 trial

Postpartum Depression1 trial

Bupivacaine1 trial

Inflammatory Response1 trial

Quality of Recovery1 trial

Pregnancy1 trial

Oxycodone1 trial

Pain1 trial

Spinal Anesthesia1 trial

Double-blind1 trial

Elderly1 trial

Opioids1 trial

Cesarean Delivery1 trial

Spinal Fusion1 trial

Cesarean Section1 trial

Coronary Artery Bypass1 trial

Injury1 trial

Sevoflurane1 trial

Lumbar Erector Spinae Plane Block1 trial

Thoracic Surgery1 trial

Opioid Free Anesthesia1 trial

Randomized Controlled Trial1 trial

Heart Disease1 trial

Efficacy1 trial

Patient-controlled Intravenous Analgesia1 trial

Knee Replacement Surgery1 trial

Nerve Block1 trial