Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities

1. Background Suicide is a major public health challenge with over 800,000 deaths annually worldwide. Brazil experienced a concerning 57% increase in suicide rates between 2000-2019, highlighting urgent need for effective prevention strategies. This study evaluates two promising interventions: esketamine (rapid-acting pharmacological treatment) and Crisis Response Planning (CRP, evidence-based psychological safety planning approach) in a real-world Brazilian public health setting.
2. Study Design
Pragmatic randomized controlled trial with hybrid implementation-effectiveness design comparing three approaches in emergency departments across two Brazilian cities with combined population of 310,000:
* Group A: Single esketamine infusion (0.5 mg/kg over 40 minutes) + optimized usual treatment (OUT)
* Group B: Crisis Response Planning + OUT
* Group C: OUT alone (enhanced control)
3. Participants
Adults and adolescents (≥14 years) presenting with high suicide risk defined as:
* Recent suicide attempts within 30 days (actual, interrupted, or aborted)
* Severe suicidal ideation (Columbia-Suicide Severity Rating Scale questions 4-5 positive)
* Non-suicidal self-harm requiring emergency medical attention
4. Target enrollment:
272 participants per group (816 total). Key exclusions: esketamine contraindications (cardiovascular disease, aneurysms), psychotic disorders, severe substance use disorders, pregnancy/lactation, inability to consent.
5. Interventions
1. Esketamine Group: IV infusion administered in medical setting with continuous 4-hour monitoring (pulse, blood pressure, ECG, oxygen saturation). Trained medical staff and emergency protocols available.
2. Crisis Response Planning: Collaborative intervention delivered by trained clinical psychologists. 20-45 minute sessions creating personalized, written safety plans identifying warning signs, internal coping strategies, social support contacts, professional resources, and means restriction.
3. Optimized Usual Treatment: Enhanced standard care including guaranteed psychiatric follow-up appointment within one week through municipal mental health services (CAPS - Psychosocial Care Centers).
6. Primary Outcome Repeated suicide-related events over one year including suicide attempts, interrupted attempts, suicide-prevention hospitalizations, deaths by suicide, and non-suicidal self-harm requiring medical attention.
7. Comprehensive Data Collection
1. Biomarkers: 10mL venous blood samples (2 EDTA tubes) collected at baseline by senior clinical nurses. Comprehensive laboratory analysis including complete blood count, metabolic panel, vitamins (B1, B2, B6, B12, B9, D, K), hormones (TSH, T3, T4, testosterone, DHEA, prolactin), inflammatory markers (CRP), brain-derived neurotrophic factor (BDNF), platelet monoamine oxidase (MAO), minerals (iron, ferritin, magnesium, zinc, selenium), and lipid profiles. Samples processed within 24 hours and stored at -80°C for analysis.
2. Clinical Assessments: Comprehensive evaluations at 11 time points (baseline, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, 1 year) using validated instruments: Columbia-Suicide Severity Rating Scale (C-SSRS), depression scales (PHQ-9, MADRS), anxiety (GAD-7), quality of life (SF-36v2), impulsivity (BIS-11), trauma history (MACE), substance use (ASSIST), sleep quality (PSQI), and additional psychosocial measures.
3. Ecological Momentary Assessment: Real-time data collection via smartphone application for consenting participants. Six daily prompts assessing mood, suicidal thoughts, and emotional states using validated scales. Previous research demonstrates safety and high compliance rates in suicide research populations.
8. Secondary Outcomes
* Time to new suicidal crisis or psychiatric emergency
* Changes in depression and anxiety severity scores
* Quality of life and functional outcome improvements
* Treatment response variability by demographic factors (age, gender, socioeconomic status)
* Comprehensive cost-effectiveness analysis including direct medical costs and indirect productivity losses
* Patient and clinician satisfaction with treatment modalities
* Implementation barriers and facilitators using Consolidated Framework for Implementation Research (CFIR)
* Biomarker predictors of treatment response
9. Clinical Significance This represents the first large-scale, real-world direct comparison of rapid-acting pharmacological (esketamine) versus evidence-based psychological (CRP) interventions for suicide prevention within a public health system. Results will provide crucial evidence for clinical practice guidelines and inform implementation of these interventions in Brazil and similar global contexts. The pragmatic design ensures findings are directly applicable to routine emergency department practice, while comprehensive biomarker analysis may identify biological predictors of treatment response to personalize suicide prevention approaches.

Start Date01 Jan 2026

Sponsor / Collaborator

University of Sao Paulo

NCT07063108

/ Not yet recruitingPhase 4IIT

Efficacy and Safety of S-ketamine Hydrochloride Injection in Elderly Patients Undergoing Elective Non-cardiac Surgery: a Multicenter, Randomized, Placebo Controlled Clinical Trials?ESSENCE?

This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of postoperative depression and delirium.

Start Date01 Dec 2025

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT06468436

/ Not yet recruitingNot ApplicableIIT

Effect of Dexmedetomidine-Esketamine Combination for Sedation and Analgesia on Delirium in ICU Patients With Mechanical Ventilation: A Multicenter Randomized Trial

Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.

Start Date01 Nov 2025

Sponsor / Collaborator

Peking University First Hospital

[+2]

100 Clinical Results associated with Esketamine Hydrochloride

100 Translational Medicine associated with Esketamine Hydrochloride

100 Patents (Medical) associated with Esketamine Hydrochloride

2,294

Literatures (Medical) associated with Esketamine Hydrochloride

31 Dec 2025·ANNALS OF MEDICINE

Respiratory depression in women receiving propofol/esketamine versus propofol/fentanyl for abortion surgery or curettage: a randomized clinical trial

Article

Author: Chen, Huihe ; Guan, Xuehai ; Luo, Jiaxin ; Wu, Xiaoshan ; Cao, Huiyu ; Lan, Hongmeng ; Lin, Yuliu ; Zhang, Cuiwen ; Liao, Yeqing ; Huang, Xiaofang

BACKGROUND:

A combination of opioids with propofol is a popular approach to non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression. We compared the incidence of esketamine- and fentanyl-induced respiratory depression in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

METHODS:

This study included 176 women (aged 18-60 years) scheduled for abortion surgery or curettage. Patients were randomized into the fentanyl or esketamine groups. Patients in the fentanyl group received fentanyl (1 µg/kg) combined with propofol intravenously. Patients in the esketamine group received subanaesthetic doses of esketamine (0.15 mg/kg) combined with propofol intravenously. The primary outcome was the incidence of respiratory depression during anaesthesia. Secondary outcomes included respiratory rate, pulse oximetry, blood pressure, heart rate, propofol dose, duration of surgery, duration of anaesthesia, and adverse events.

RESULTS:

The incidence of respiratory depression in the esketamine group was significantly lower than that in the fentanyl group (11% vs. 45%; p < .0001). Propofol administration was lower with esketamine than fentanyl. Respiratory rate, SpO₂ and blood pressure were more stable in the esketamine group than in the fentanyl group. The incidences of hypotension, propofol-induced injection pain and chin lifting in the esketamine group were lower than those in the fentanyl group. The incidence of nightmares was higher in the esketamine than in the fentanyl group.

CONCLUSIONS:

The incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.KEY MESSAGESOpioids combined with propofol is a popular method for non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression.At subanaesthetic doses, esketamine provides an analgesic effect by antagonizing the N-methyl-d-aspartate receptor.In this trial, the incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

31 Dec 2025·ANNALS OF MEDICINE

Opioid-free anaesthesia to reduce postoperative nausea and vomiting after lower extremity wound surgery: a randomised double-blind crossover trial

Article

Author: Liu, Hua-yue ; Ying, Yao-yu ; Qian, Long ; Zhu, Ya-juan ; Ji, Fu-hai ; Liu, Hong ; Peng, Ke

BACKGROUND:

Postoperative nausea and vomiting (PONV) are common complications after surgery. Opioid use is a significant risk factor. We utilised a crossover design to test this hypothesis in the same individuals that opioid-free anaesthesia (OFA) compared with opioid-inclusive anaesthesia reduces PONV.

METHODS:

This randomised double-blind crossover trial included adult patients undergoing two surgical procedures for lower extremity wounds under general anaesthesia. Each patient received both OFA (i.v. lidocaine, esketamine, dexmedetomidine and propofol) and opioid-inclusive anaesthesia (sufentanil and propofol); which came first was determined by randomisation. The primary outcome was the incidence of PONV during the first 48 h postoperatively. Secondary outcomes were the severity of PONV, use of rescue antiemetics, postoperative pain, need for rescue analgesia, adverse events, time to extubation, and length of recovery room stay.

RESULTS:

Sixty-six patients completed this study (mean age 53 years, 36% female). The median washout period was 9 days. Compared with opioid-inclusive anaesthesia, OFA reduced the incidence of PONV 0-48 h postoperatively (5% vs. 23%, odds ratio [OR] = 0.13, 95% CI: 0.03-0.55, p = 0.006), which remained significant in the prespecified adjusted analysis (OR = 0.06, 95% CI: 0.01-0.32, p = 0.001). OFA also led to a reduced severity of PONV, a lower rate of hypotension, and a longer time to extubation. Postoperative pain and other outcomes were similar between the two anaesthetic techniques.

CONCLUSION:

This crossover trial demonstrates that OFA reduced PONV following lower extremity wound surgery, providing compelling evidence for the administration of OFA to enhance perioperative care.

REGISTRATION:

ChiCTR2200061511 (https://www.chictr.org.cn).

31 Dec 2025·ANNALS OF MEDICINE

Effects of esketamine infusion on tourniquet-induced hypertension in patients undergoing below-knee orthopedic surgery: protocol for a randomized controlled trial

Article

Author: Ying, Yao-yu ; Shi, Hai-jing ; Ji, Fu-hai ; Jiang, Kai ; Peng, Ke ; Zhao, Wen-qian ; Zhuang, Min-yuan

INTRODUCTION:

Application of a tourniquet reduces surgical bleeding while causing pain and tourniquet-induced hypertension (TIH). Deeper anesthesia and additional opioids are often insufficient to mitigate TIH but are associated with prolonged recovery and complications. Herein, we describe the protocol for a clinical trial investigating whether intraoperative esketamine infusion would reduce the rate of TIH during below-knee orthopedic surgery.

PATIENTS AND METHODS:

This prospective, randomized, double-blind, controlled trial will include a total of 80 adults scheduled for below-knee orthopedic surgery under general anesthesia. Patients will be randomly assigned in a 1:1 ratio to receive either esketamine infusion at 0.25 mg/kg/h or normal saline infusion after anesthesia induction and during tourniquet inflation. Both groups will receive ultrasound-guided unilateral popliteal sciatic nerve block and adductor canal block with 0.25% ropivacaine. The primary outcome is the occurrence of TIH, defined as an increase in systolic blood pressure >30% of baseline during tourniquet inflation. Secondary outcomes include the incidence of hypotension during surgery; intraoperative hemodynamic changes; intraoperative opioid dose and total amount of esmolol; postoperative nausea and vomiting, dizziness, and mental side effects; postoperative pain at 1, 6, 12, and 48 h after surgery; postoperative analgesic consumption within 48 h after surgery; and length of postoperative hospital stay. Additionally, we will assess patients' quality of recovery at 24 h after surgery.

DISCUSSION:

This trial will determine the effects of esketamine infusion on TIH in patients who undergo below-knee orthopedic surgery under general anesthesia. Our results will offer a new insight into optimizing anesthetic care for surgical patients receiving tourniquet.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (ChiCTR2400081237).

376

News (Medical) associated with Esketamine Hydrochloride

20 Aug 2025

·www.globenewswire.com

BrainsWay Acquires Minority-Stake in Axis Integrated Mental Health

The Investment is part of BrainsWay’s ongoing strategy to acquire minority positions in leading U.S. mental health providers to help them raise awareness for and expand access to transformative careBURLINGTON, Mass. and JERUSALEM, Aug. 20, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has entered into a strategic equity financing agreement with Axis Management Company, Inc. (“Axis Integrated Mental Health” or “Axis”), a management services organization servicing several mental health clinics in Colorado. Under the terms of the agreement, BrainsWay will invest $2.3 million initially, and an additional potential $1 million milestone-based investment, for a minority position in Axis in the form of a preferred, annually compounding security. The agreement also provides for a redemption mechanism relating to the shares. “Our minority-stake investment in Axis follows our previous investment in Stella, and is part of BrainsWay’s broader initiative to accelerate access to and awareness of innovative mental health treatments, including Deep TMS Therapy, while continuing to maintain our core focus on advancing our scientific and technological capabilities to ensure best-in-class support for all our customers. Within this strategy, our investments provide capital injections into high performing healthcare providers, which then allows these businesses to invest in growth drivers and launch new locations,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We see tremendous opportunities for these healthcare providers to offer expanded services and grow their businesses once they secure the necessary capital.” “Axis offers a robust clinical services platform and is committed to achieving rapid growth and excellent patient outcomes. We are thrilled to support and collaborate with them as their business continues to scale from a well-respected regional platform to one with a larger footprint, enhancing their delivery of life-changing care to additional patients,” concluded Mr. Levy. “Our partnership with BrainsWay was born out of a mutual desire to deliver the best cutting-edge mental health treatments to the communities we serve,” stated Chris Perez, Chief Executive Officer of Axis. “Given the peerless reputation of BrainsWay and its proprietary Deep TMS technology, we realize the value this strategic partnership will provide as we further advance in our mission of putting patients first through our best-in-class support.” About BrainsWay BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com. About Axis Axis Integrated Mental Health services its leading mental health practices, which are dedicated to transforming lives through a truly comprehensive, integrative model of care. With a team of board-certified specialists combining modern psychiatry and psychotherapy with advanced treatments including Deep TMS™ and Spravato®, Axis utilizes an evidence-based, holistic therapeutic approach to treat patients, all through a single, coordinated care experience under one roof. For more information, please visit axismh.com. Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission. Contacts: BrainsWay:Ido MaromChief Financial OfficerIdo.Marom@BrainsWay.com Investors:Brian RitchieLifeSci Advisors LLCbritchie@lifesciadvisors.com

License out/in

15 Aug 2025

·www.prnewswire.com

Relief Mental Health Adds Trauma-Informed Psychiatric Provider Michael Henderson to West Allis Clinic, Expanding SPRAVATO® and Psychiatry Services

WEST ALLIS, Wis., Aug. 15, 2025 /PRNewswire/ -- Relief Mental Health is pleased to announce the addition of Michael Henderson, MSN, APNP, PMHNP-BC, to its West Allis clinic. As a board-certified psychiatric mental health nurse practitioner, Henderson expands access to high-quality, trauma-informed psychiatric care for individuals across the Milwaukee area. Henderson specializes in medication management and SPRAVATO® (esketamine) administration for those experiencing depression, anxiety, and obsessive-compulsive disorder (OCD). He brings particular expertise in trauma-related disorders, including PTSD and complex trauma, developed through years of clinical experience serving veterans at the VA Medical Center in Milwaukee. His trauma-informed, patient-centered approach emphasizes safety, stabilization, and trust-building as foundational elements of care. He integrates evidence-based psychopharmacologic interventions with comprehensive diagnostic assessment and ongoing monitoring to support long-term recovery and improved functioning. He prioritizes expedited access to care, understanding the importance of early intervention and timely treatment adjustments in improving outcomes for patients with complex psychiatric needs. Relief Mental Health operates two Wisconsin clinics—West Allis and Middleton (just outside of Madison)—offering patients across the state access to advanced psychiatric services and timely care. At Relief, medication management is tailored to each patient's unique needs, with a focus on both symptom relief and overall well-being. Henderson also works closely with a multidisciplinary team to coordinate care and refer patients to complementary services offered by Relief, such as transcranial magnetic stimulation (TMS), when clinically appropriate. For adults facing treatment-resistant depression, Henderson provides SPRAVATO® (esketamine)—an FDA-approved nasal spray that works differently than traditional antidepressants by targeting glutamate pathways in the brain. This innovative treatment can offer rapid symptom relief for patients who have not responded to other interventions, offering a renewed sense of hope and progress. Prior to joining Relief, Henderson cared for veterans at the VA Medical Center in Milwaukee, where he developed individualized treatment plans, managed complex medication regimens, and supported patients through education and trauma-informed care. His work with the veteran community strengthened his commitment to delivering evidence-based care to those most in need. Henderson is currently accepting new patients and has immediate availability for appointments. To schedule a visit, call 855.205.4764 or go to reliefmh.com. About Relief Mental Health Relief Mental Health is a leading outpatient provider of transcranial magnetic stimulation (TMS), SPRAVATO® (esketamine), IV ketamine, psychiatry, and therapy for the treatment of depression, OCD, anxiety, and other mental health conditions. Founded in 2020, Relief is committed to expedited access to care and delivering innovative, evidence-based treatments across a full continuum of services. Relief operates 12 clinics across four states—Colorado, Illinois, New Jersey, and Wisconsin—and is dedicated to setting a new standard for mental health care through empathy, clinical excellence, and ongoing responsiveness to evolving patient needs. For more information, visit reliefmh.com. CONTACT: Melanie Eilers Chief Marketing Officer [email protected] SOURCE Relief Mental Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive Change

12 Aug 2025

·www.pharmaceutical-technology.com

Third time lucky as PharmaTher gets FDA approval for ketamine

PharmaTher’s Ketarx has received FDA approval for use as a post-operative pain (PoP) reliever, making it the first ketamine product to be approved for this purpose. Image credit: Fat Camera, E+ via Getty Images. Canada-based PharmaTher has received US Food and Drug Administration (FDA) approval for its ketamine therapy for surgical pain management, KETARx (racemic ketamine), on its third attempt. This comes after two previous rejections in April 2024 and October 2024, each citing minor deficiencies in the abbreviated new drug applications (NDAs) for the therapy in anaesthesia, mental health, neurological indications, pain and sedation. Ketarx’s approval marks the first time the FDA has approved a ketamine product in an analgesic setting. Following this decision, PharmaTher announced plans to explore Ketarx’s potential in other indications through clinical trials focusing on “mental health, as well as neurological and pain disorders”, said the company’s CEO and chair Fabio Chianelli, in a statement on 11 August. Ketamine, the only psychedelic therapy to be named on the World Health Organization’s (WHO) model list of essential medicines, has been prescribed off-label for a range of mental health, pain and neurological conditions by physicians in the US. Ketamine has been included on the FDA drug shortage list since 2018, with the agency sharing concerns about the compounded version of the drug being used in the treatment of psychiatric disorders. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Jannsen Pharmaceuticals’ Spravato (esketamine) is also a ketamine based product that first gained approval as a combination therapy with oral antidepressants in patients with treatment-resistant depression in 2019. Spravato has since received a label expansion for its use as a monotherapy in treatment-resistant depression in January 2025. However, clinical research into ketamine outside of the anaesthetic setting has faced significant hurdles, primarily due to the lack of standardisation in treatment length, dosage and administration between trials. Issues related to trial standardisation have resulted in the termination of nine Phase III and IV clinical trials within the last five years, including a study run by Qinghai University on the effects of esketamine on postpartum depression, according to GlobalData’s Intelligence Centre. GlobalData is the parent company of Pharmaceutical Technology . Ketamine’s future potential in pharma Following Ketarx’s approval, PharmaTher will join Spravato on the market, with these being the only two ketamine-based drugs approved for use outside of anaesthesiology. Forecasts suggest that Spravato reached blockbuster status in 2024. GlobalData analysts estimate the drug will make $1.4bn in 2025, with sales rising to $3.4bn in 2031. With the value of ketamine-based therapies poised to grow significantly in the coming years, Ketarx could be set to thrive in this market, potentially replacing the use of opioids, which have high abuse potential. There are other non-opioid-based pain therapies both in trials and on the market, including Vertex Pharmaceuticals’ Journavx (suzetrigine) , which gained approval in moderate-to-severe acute pain in January 2025. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Drug ApprovalPhase 3

100 Deals associated with Esketamine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10627	Esketamine Hydrochloride	N01AX14 N06AX27	DB11823

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder	China	Janssen-Cilag International NV	17 Apr 2023
Major depressive disorder, moderate (MDD)	Australia	Janssen-Cilag Pty Ltd.	09 Mar 2021
Depressive Disorder, Major	European Union	Janssen-Cilag International NV	18 Dec 2019
Depressive Disorder, Major	Iceland	Janssen-Cilag International NV	18 Dec 2019
Depressive Disorder, Major	Liechtenstein	Janssen-Cilag International NV	18 Dec 2019
Depressive Disorder, Major	Norway	Janssen-Cilag International NV	18 Dec 2019
Anesthesia	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Nov 2019
Depressive Disorder, Treatment-Resistant	United States	Janssen Pharmaceuticals, Inc.	05 Mar 2019
Pain	Germany	Pfizer Inc.	01 Aug 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Suicidal Ideation	Phase 3	United States	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Bulgaria	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Estonia	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Germany	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Hungary	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Malaysia	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Slovakia	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	South Africa	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Spain	Janssen Research & Development LLC	09 Jun 2017
Suicidal Ideation	Phase 3	Taiwan Province	Janssen Research & Development LLC	09 Jun 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04599855 (Pubmed \| JAMA Psychiatry) Manual	Phase 4	Depressive Disorder, Treatment-Resistant	378	esketamine 56 mg	pvkoyngcnv(cvomipnbbs) = nausea (56 participants [24.8%]), dissociation (55 [24.3%]), dizziness (49 [21.7%]), and headache (43 [19.0%]). zyugmjwfeg (zgygmnnqxd )	Positive	02 Jul 2025
				esketamine 84 mg
NCT02782104 (SUSTAIN-3, Pubmed \| Int J Neuropsychopharmacol)	Phase 3	Depressive Disorder, Treatment-Resistant	1,148	Esketamine nasal spray + oral antidepressant	yvwexoiazq(qivbyunauv) = n = 3 rynrlahane (bgrsykwcsn ) View more	Positive	06 Jun 2025
Pubmed \| JAMA Psychiatry Manual	Not Applicable	Depressive Disorder, Treatment-Resistant	-	Esketamine + SNRI	opehtwbdxf(jhjmbkfciy) = oanhsehxdz vwegcnpotw (adomsazrhu ) View more	Positive	02 Apr 2025
				Esketamine + SSRI	opehtwbdxf(jhjmbkfciy) = drmewtzxuk vwegcnpotw (adomsazrhu ) View more
NCT03185819 (Pubmed \| J Am Acad Child Adolesc Psychiatry)	Phase 2	Depressive Disorder, Major	147	Esketamine 28 mg	yauojjlztm(bjxgikotwy) = incidence ≥20% qknosmlmxe (tzdsrymwdm ) View more	Positive	01 Mar 2025
				Esketamine 56 mg
NCT05464979 (Pubmed \| Sci Rep)	Phase 4	-	80	Esketamine	utauaraybv(whespfzhqb) = lefsofylla xmgryyqrtf (tjjrljlamy, 4.0 - 16.3)	Positive	19 Feb 2025
				Midazolam/sufentanil admixture	utauaraybv(whespfzhqb) = sjxgbwioog xmgryyqrtf (tjjrljlamy, 8.0 - 26.0)
ChiCTR2200065494 (Pubmed \| JAMA Netw Open)	Phase 4	Depression, Postpartum	308	Esketamine	enghhgrcho(mqcfatnznr) = cqduhprucl wxczwhpckv (aelkmilykj )	Positive	13 Feb 2025
				Saline	enghhgrcho(mqcfatnznr) = xavwildmuc wxczwhpckv (aelkmilykj )
ChiCTR2400087873 (Pubmed \| BMC Anesthesiol)	Not Applicable	Sedation \| Anxiety Disorders	90	Intranasal Dexmedetomidine	kkvgfqiuyh(mjzoddobqg) = bradycardia, hypotension, hypoxia, emergence delirium etc. xcgpuvpuel (khczsimkfr )	Positive	11 Feb 2025
				Intranasal Dexmedetomidine-Esketamine
ChiCTR2300069632 (Pubmed) Manual	Not Applicable	Pain	135	esketamine	cjwxfqibpx(ttunnwrjoa): P-Value = P<0.05 View more	Positive	20 Jan 2025
				sufentanil
NCT04599855 (FDA_CDER) Manual	Phase 4	Depressive Disorder, Treatment-Resistant	-	SPRAVATO (56 mg)	cqtxhbgvpz(xsaszvjyis) = xbndiibpci yteaclxdrq (xugkwdhqco, 1.2)	Positive	17 Jan 2025
				SPRAVATO (84 mg)	cqtxhbgvpz(xsaszvjyis) = rbnibyuigz yteaclxdrq (xugkwdhqco, 1.2)
NCT03097133 \| NCT03039192 (FDA_CDER) Manual	Phase 3	Depressive Disorder, Major	-	SPRAVATO 84 mg +SOC (NCT03039192)	isdaipnvof(tznwcbmgvk) = elfohztftv ocyrzmfufg (puitlmfobz, 1.04)	Positive	17 Jan 2025
				Placebo nasal spray + SOC (NCT03039192)	isdaipnvof(tznwcbmgvk) = dabmntgpwt ocyrzmfufg (puitlmfobz, 1.02)

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Core Patent

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis