Spravato

(Esketamine)

ApprovedSmall molecule

Esketamine is used to treat severe depression, particularly in people who haven't responded well to other antidepressants, and to reduce suicidal thoughts in people in crisis.[2] Spravato is currently approved and in use across 44 indications[4].[1]

Spravato is one of 747 small molecule programs targeting Treatment Resistant Depression. It is currently in Approved.

Indications

148

Total Trials

Active Trials

746

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Treatment Resistant DepressionCompleted

DeliriumCompleted

PhimosisActive, not recruiting

Kidney DiseaseApproved

Laparoscopic CholecystectomyCompleted

Liver DiseaseApproved

Depressive DisorderApproved

Drug DependenceApproved

Cancer PainApproved

Autism Spectrum DisorderActive, not recruiting

Treatment Resistant DepressionApproved

Completed

DeliriumApproved

Completed

PhimosisPreclinical

Active, not recruiting

Kidney DiseaseApproved

Approved

Laparoscopic CholecystectomyPreclinical

Completed

Liver DiseaseApproved

Approved

Depressive DisorderApproved

Approved

Drug DependenceApproved

Approved

Cancer PainApproved

Approved

Autism Spectrum DisorderPreclinical

Active, not recruiting

Showing 10 of 41 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Spravato

WWim Janssens

Approved

2 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Acupan

YYonsei University

Preclinical

1 10

Paracetamol

GSK

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Acute Pain

NCT06853041

ApprovedNot yet recruiting

Adverse Respiratory Events

NCT07748884

N/ANot yet recruiting

Hemodynamic Stability

NCT07374458

PreclinicalRecruiting

Circadian Rhythm

NCT07315074

Q1 2027

PreclinicalNot yet recruiting

Perioperative Neurocognitive Disorders

NCT07665099

Q2 2027

PreclinicalNot yet recruiting

Pruritus

NCT07760740

Clinical

Trials by Indication[1]

Esketamine25 trials

Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02857777·37 enrolled

Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray

Unknown status·LLukas Pezawas·N/A·NCT04843462·70 enrolled

Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02345148·16 enrolled

Show 22 more trials

ECT vs. Esketamine

Withdrawn·MMedical University Innsbruck·Phase 3·NCT04924257

(GluEsk) Glutamate and Esketamine

Completed·UUniversity of Oxford·N/A·NCT06432322·16 enrolled

A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02674295·8 enrolled

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Unknown status·—·Phase 4·NCT03421275·105 enrolled

A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02343289·18 enrolled

A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03298906·16 enrolled

Effect of Esketamine on Conscious State in Patients With pDoC

Recruiting·—·N/A·NCT06389344·116 enrolled

Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Completed·TTongji Hospital·N/A·NCT05686863·106 enrolled

Esketamine and Butorphanol for Post-Lobectomy Pain

Completed·—·Phase 4·NCT06398834·223 enrolled

A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02060929·14 enrolled

Ayahuasca, Esketamine and PTSD

Recruiting·UUniversity of Sao Paulo·Phase 2·NCT07317206·10 enrolled

The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision Pediatric Circumcision

Completed·YYangzhou University·N/A·NCT04698434·90 enrolled

Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02228239·26 enrolled

Median Effective Dose of Esketamine Pretreatment to Prevent Sufentanil-induced Cough

Unknown status·YYangzhou University·N/A·NCT05809804·30 enrolled

A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01980303·29 enrolled

ED50 of Esketamine for Laser Treatment in Children

Unknown status·—·N/A·NCT06294639·40 enrolled

Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02568176·71 enrolled

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01780259·58 enrolled

Ayahuasca, Esketamine and Premenstrual Symptoms

Recruiting·UUniversity of Sao Paulo·N/A·NCT07317232·20 enrolled

Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02846519·66 enrolled

Ayahuasca, Esketamine and Body Image Perception

Recruiting·UUniversity of Sao Paulo·N/A·NCT07317219·20 enrolled

A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02129088·34 enrolled

Treatment Resistant Depression15 trials

A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03434041·252 enrolled

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02782104·1,148 enrolled

A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01998958·108 enrolled

Show 12 more trials

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02497287·802 enrolled

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT04599855·477 enrolled

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03852160

Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression

Recruiting·RRiccardo Guglielmo··NCT07146503·100 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02417064·346 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02422186·139 enrolled

An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04476446·41 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02418585·236 enrolled

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02493868·719 enrolled

A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05268497

VA Aripiprazole vs Esketamine for Treatment Resistant Depression

Withdrawn·VVA Office of Research and Development·Phase 4·NCT05554627

A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01640080·30 enrolled

Major Depressive Disorder10 trials

54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03097133·230 enrolled

The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Recruiting·—·Phase 3·NCT05973851·418 enrolled

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

Recruiting·—·Phase 3·NCT05603104·1,254 enrolled

Show 7 more trials

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03185819·147 enrolled

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04338321·676 enrolled

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT04829318·183 enrolled

54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03039192·226 enrolled

A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02919579·27 enrolled

A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02133001·68 enrolled

Positioning of Esketamine Treatment in the Real-world Management of Depression

Recruiting·RRoyal North Shore Hospital·Approved·NCT06103760·162 enrolled

Sedation5 trials

Comparison of Sedation by Esketamine and Sevoflurane

Unknown status·EEye & ENT Hospital of Fudan University·Phase 4·NCT05011214·60 enrolled

Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

Unknown status·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT05925283·126 enrolled

Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure

Completed·EEye & ENT Hospital of Fudan University·N/A·NCT05321160·116 enrolled

Show 2 more trials

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Recruiting·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT06853431·80 enrolled

Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Completed·PPeking University·Phase 4·NCT04597320·48 enrolled

Dexmedetomidine4 trials

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Recruiting·PPeking University First Hospital·Phase 4·NCT06087510·312 enrolled

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Recruiting·PPeking University First Hospital·Phase 4·NCT06399185·1,740 enrolled

Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality

Completed·PPeking University First Hospital·Phase 4·NCT05732064·180 enrolled

Show 1 more trial

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

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

68 more indications

Delirium4 trials

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

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

Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery

Withdrawn·RRenJi Hospital·N/A·NCT06900205

Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium

Completed·PPeking University First Hospital·Phase 4·NCT06566469·340 enrolled

Show 1 more trial

Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)

Recruiting·NNanfang Hospital, Southern Medical University·N/A·NCT06817239·1,670 enrolled

Depression4 trials

Brain Network Dynamics of Depression During Esketamine Treatment

Completed·UUniversity of North Carolina, Chapel Hill··NCT06012916·8 enrolled

Effect of Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth

Active, not recruiting·PPeking University First Hospital·Phase 4·NCT05698394·364 enrolled

Personalized DBS Targeting for Treating Depression

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 1·NCT06784388·5 enrolled

Show 1 more trial

Behavioural Activation Therapy and Esketamine for Resistant Depression

Terminated·TThe Royal's Institute of Mental Health Research·N/A·NCT06431386·6 enrolled

Anxiety4 trials

Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients

Unknown status·HHenan Provincial People's Hospital·Phase 1·NCT06073015·200 enrolled

Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery

Completed·ZZhejiang Cancer Hospital·N/A·NCT06530706·185 enrolled

Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients

Recruiting·TTianjin Medical University General Hospital·N/A·NCT06108830·400 enrolled

Show 1 more trial

Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

Completed·TTianjin Medical University General Hospital·N/A·NCT06284668·315 enrolled

Septic Shock2 trials

Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

Unknown status·NNanfang Hospital, Southern Medical University·Phase 3·NCT05839366·124 enrolled

Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation

Unknown status·TThe First Hospital of Jilin University·N/A·NCT05551910·120 enrolled

Major Depression2 trials

Ayahuasca and Esketamine for Major Depression

Completed·UUniversity of Sao Paulo·Phase 2·NCT07212946·22 enrolled

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol

Recruiting·YYale University··NCT06725277·450 enrolled

Post Operative Pain2 trials

The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy

Completed·FFujian Provincial Hospital·Phase 1·NCT06559280·84 enrolled

Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery

Active, not recruiting·TThe Second People's Hospital of Huai'an·Phase 1/2·NCT06920576·144 enrolled

Postpartum Depression2 trials

Esketamine on Postpartum Depression in Cesarean Section Women

Completed·AAilin Luo·N/A·NCT04860661·336 enrolled

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

Thoracoscopic Surgery2 trials

An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery

Completed·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05458453·80 enrolled

Effects of Esketamine on Oxygenation and Quality of Recovery in Patients Undergoing Thoracoscopic Surgery

Not yet recruiting·JJinqiao Qian·Phase 4·NCT06822088·126 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

Suicide2 trials

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Recruiting·MMassachusetts General Hospital·Phase 4·NCT05450432·100 enrolled

Esketamine Versus Crisis Response Planning Versus Enhanced Treatment as Usual for Suicide Prevention: A Pragmatic Randomized Trial in a Brazilian Municipality (SAVE)

Recruiting·UUniversity of Sao Paulo·Approved·NCT07120477·478 enrolled

Breast Cancer2 trials

Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

Completed·YYangzhou University·N/A·NCT04850937·90 enrolled

Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

Recruiting·—·Phase 4·NCT04303325·72 enrolled

Acute Pain2 trials

ESKetamine Low-dose vs Ketamine Low-dose for Severe Acute Pain in Emergency Units, Comparison of PsychodyslEptic Effects

Recruiting·—·Phase 4·NCT06853041·74 enrolled

Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Terminated·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 3·NCT06051227·235 enrolled

Ketamine2 trials

Imaging Neural Correlates of Ketamine Using PET/MR

Recruiting·MMedical University of Vienna·Phase 1·NCT04587778·65 enrolled

The Use of S+Ketamine Versus Placebo During Target-Controlled Intravenous Anaesthesia to Reduce Morphine Consumption and Side Effects After Abdominal Hysterectomy: A Randomized Controlled Trial

Completed·KKK Women's and Children's Hospital·Phase 2·NCT03231683·90 enrolled

Hemodynamic Stability2 trials

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

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

Effects of Esketamine and Bilateral Lower Limb Elevation on Hemodynamic Stability During Induction of General Anesthesia in Elderly Patients Undergoing Thoracic Surgery

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·N/A·NCT07374458·292 enrolled

Depressive Disorder, Treatment-Resistant2 trials

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07716098·348 enrolled

An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Esketamine Nasal Spray in Korean Participants With Treatment-Resistant Depression(TRD)

Completed· Johnson & Johnson logo

Johnson & Johnson·Approved·NCT07053345·47 enrolled

Interaction1 trial

KF2024#1-trial: Esketamine Interaction Study

Completed·HHelsinki University Central Hospital·Phase 1·NCT06726382·12 enrolled

Efficacy and Safety1 trial

Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain

Withdrawn·UUniversity Hospital, Basel, Switzerland·Phase 2·NCT04666623

Cardiac Repolarization1 trial

A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02737605·62 enrolled

Attention1 trial

Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI

Completed·RRupert Lanzenberger·Phase 1·NCT05320120·33 enrolled

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02611505·24 enrolled

Spinal Cord Injury1 trial

Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

Not yet recruiting·—·N/A·NCT06531837·60 enrolled

Abuse Potential1 trial

Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02682225·55 enrolled

Inflammatory Bowel Disease1 trial

The Effects of Intraoperative Esketamine on Postoperative Pain and Mood in Patients With Inflammatory Bowel Disease

Completed·JJinling Hospital, China·Phase 4·NCT05506787·120 enrolled

Allergic Rhinitis1 trial

Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02154334·47 enrolled

Abortion1 trial

Remimazolam Versus Propofol for Painless Abortion

Completed·MMaternal and Child Health Hospital of Hubei Province·Phase 2·NCT05635955·100 enrolled

Intraoperative1 trial

Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04682782·26 enrolled

Postoperative Quality of Recovery1 trial

Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery

Not yet recruiting·PPeking University First Hospital·Phase 4·NCT07308756·316 enrolled

Cesarean Section1 trial

A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section

Completed·WWomen's Hospital School Of Medicine Zhejiang University·Phase 4·NCT04548973·600 enrolled

Scoliosis1 trial

Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery

Recruiting·PPeking University First Hospital·Phase 4·NCT06062550·312 enrolled

Gastrointestinal Function1 trial

Effect of Subanesthetic Dose of Esketamine on Sleep Quality and Recovery of Gastrointestinal Function in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery in the Early Postoperative Period

Completed·ZZhuan Zhang·N/A·NCT05715671·138 enrolled

Postoperative Recovery1 trial

Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery

Active, not recruiting·NNorthern Jiangsu People's Hospital·N/A·NCT06976996·190 enrolled

Sleep Disturbance1 trial

The Effect of Esketamine on Sleep Disturbance

Completed·TTianjin Medical University General Hospital·N/A·NCT06388824·204 enrolled

Obesity1 trial

Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery

Recruiting·GGöteborg University·N/A·NCT03756961·220 enrolled

Critically Ill Patients1 trial

Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients

Completed·FFederal University of São Paulo·Phase 2·NCT05092152·207 enrolled

Thoracic Paravertebral Block1 trial

Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery

Completed·TThe First Hospital of Qinhuangdao·N/A·NCT05341375·110 enrolled

Anesthesia1 trial

Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

Recruiting·—·N/A·NCT06430645·150 enrolled

Suicidality1 trial

Esketamine vs ECT for Acute Suicidality

Completed·—·N/A·NCT06355180·340 enrolled

Postoperative Pain Relief1 trial

The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT06300944·100 enrolled

Postoperative Sleep Disturbance1 trial

Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Recruiting·—·N/A·NCT06451627·156 enrolled

Treatment Resistant Depression (TRD)1 trial

Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT03829579

Parkinson's Disease1 trial

Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease

Recruiting·—·N/A·NCT06543563·102 enrolled

Bariatric Surgery1 trial

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression

Not yet recruiting·TThe First Hospital of Jilin University·Phase 4·NCT07179913·40 enrolled

Cognitive Function1 trial

A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02094378·24 enrolled

Pain After Surgery1 trial

Effect of Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Pain After Surgery

Unknown status·TTianjin Medical University General Hospital·N/A·NCT05122338·160 enrolled

Valve Surgery1 trial

Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery

Completed·—·N/A·NCT06608030·142 enrolled

GIST1 trial

University of Iowa Interventional Psychiatry Service Patient Registry

Recruiting·MMark Niciu··NCT04480918·1,000 enrolled

Autism Spectrum Disorder1 trial

Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Completed·TThe Second Hospital of Nanjing Medical University·N/A·NCT05951465·46 enrolled

Effectiveness1 trial

The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Unknown status·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1·NCT04777110·396 enrolled

Renal Impairment1 trial

A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02606084·32 enrolled

Depressive Symptoms1 trial

Esketamine and Perioperative Depressive Symptoms

Completed·—·Phase 2/3·NCT04425473·435 enrolled

Cardiac Surgery1 trial

Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery

Unknown status·AAnshi Wu·N/A·NCT05155969·80 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

Ovarian Cancer1 trial

Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

Completed·ZZhejiang Cancer Hospital·N/A·NCT06624878·568 enrolled

Depressive Disorder1 trial

Metabolic Profiling of Esketamine Treatment in Depressive Disorder

Recruiting·UUniversity of Zagreb··NCT07002684·100 enrolled

Thoracic Surgery1 trial

Esketamine Anesthesia in Thoracic Surgery

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

Quadratus Lumborum Block1 trial

Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery

Unknown status·TTianjin Medical University General Hospital·N/A·NCT05964985·160 enrolled

Laparoscopic Cholecystectomy1 trial

Effects of Perioperative Intravenous Infusion Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A 2×2 Factorial Randomized Controlled Trial

Completed·TThe Second People's Hospital of Huai'an·Preclinical·NCT07131033·128 enrolled

Circadian Rhythm1 trial

Effect of Esketamine on Postoperative Sleep in Postmenopausal Women

Recruiting·ZZhuan Zhang·Preclinical·NCT07315074·164 enrolled

Irritable Bowel Syndrome1 trial

Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial

Recruiting·BBeijing Tiantan Hospital·Preclinical·NCT06788444·552 enrolled

Depressive Disorder, Major1 trial

A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07227454·258 enrolled

Pruritus1 trial

The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study

Not yet recruiting·TTianjin Medical University General Hospital·Preclinical·NCT07760740·100 enrolled

Adverse Respiratory Events1 trial

A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy

Not yet recruiting·SSecond Affiliated Hospital of Wenzhou Medical University·Approved·NCT07748884·120 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

Depth of Anesthesia1 trial

The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia

Not yet recruiting·CChina-Japan Friendship Hospital·Preclinical·NCT07699523·120 enrolled

Old Age1 trial

Effect of Mini-dose Dexmedetomidine-Esketamine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial

Completed·PPeking University First Hospital·Approved·NCT05950646·154 enrolled

Perioperative Neurocognitive Disorders1 trial

Effect of Esketamine on Postoperative Cognitive Function in Elderly Patients Undergoing Oral and Maxillofacial Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial

Not yet recruiting·XXijing Hospital·Preclinical·NCT07665099·98 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 5, 2019

SPRAVATO

NDA NDA211243

Sources

References

[1]
ClinicalTrials.gov — 148 trial records for Esketamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Spravato drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Esketamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Esketamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211243). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Spravato. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glutamate [NMDA] Receptor Negative Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[6]

Patent Cliff

Mar 20, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9592207Mar 20, 2027

8785500Mar 5, 2033

11446260Mar 14, 2034

10869844Sep 10, 2035

11173134Sep 10, 2035

2 more patents

11311500Sep 10, 2035

11883526Feb 18, 2040

Spravato

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Esketamine25 trials

Treatment Resistant Depression15 trials

Major Depressive Disorder10 trials

Sedation5 trials

Dexmedetomidine4 trials

Delirium4 trials

Depression4 trials

Anxiety4 trials

Septic Shock2 trials

Major Depression2 trials

Post Operative Pain2 trials

Postpartum Depression2 trials

Thoracoscopic Surgery2 trials

Hepatocellular Carcinoma2 trials

Suicide2 trials

Breast Cancer2 trials

Acute Pain2 trials

Ketamine2 trials

Hemodynamic Stability2 trials

Depressive Disorder, Treatment-Resistant2 trials

Interaction1 trial

Efficacy and Safety1 trial

Cardiac Repolarization1 trial

Attention1 trial

Post-Traumatic Stress Disorder1 trial

Postherpetic Neuralgia1 trial

Hepatic Impairment1 trial

Spinal Cord Injury1 trial

Abuse Potential1 trial

Inflammatory Bowel Disease1 trial

Allergic Rhinitis1 trial

Abortion1 trial

Intraoperative1 trial

Postoperative Quality of Recovery1 trial

Cesarean Section1 trial

Scoliosis1 trial

Gastrointestinal Function1 trial

Postoperative Recovery1 trial

Sleep Disturbance1 trial

Obesity1 trial

Critically Ill Patients1 trial

Thoracic Paravertebral Block1 trial

Anesthesia1 trial

Suicidality1 trial

Postoperative Pain Relief1 trial

Postoperative Sleep Disturbance1 trial

Treatment Resistant Depression (TRD)1 trial

Parkinson's Disease1 trial

Bariatric Surgery1 trial

Cognitive Function1 trial

Pain After Surgery1 trial

Valve Surgery1 trial

GIST1 trial

Autism Spectrum Disorder1 trial

Effectiveness1 trial

Renal Impairment1 trial

Depressive Symptoms1 trial

Cardiac Surgery1 trial

Painless Gastrointestinal Endoscopy1 trial

Ovarian Cancer1 trial

Depressive Disorder1 trial

Thoracic Surgery1 trial

Quadratus Lumborum Block1 trial

Laparoscopic Cholecystectomy1 trial

Circadian Rhythm1 trial

Irritable Bowel Syndrome1 trial

Depressive Disorder, Major1 trial

Pruritus1 trial

Adverse Respiratory Events1 trial

Biliary Tract Disease1 trial

Depth of Anesthesia1 trial

Old Age1 trial