Drugs / Esketamine
Esketamine
also known as
S-ketamine · esketamine hydrochloride · ESK · AM-101 · Spravato · ketamine · (R,S)-ketamine · Esketamin · +7 more
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed treatment-refractory schizophrenia 2 milestones | |||||
| Filed | EU (EMA) | — | treatment-refractory schizophrenia | 2018-10-10 | “Additionally, a Marketing Authorization Application was submitted to the EMA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults.” jnj.com ↗ “Janssen filed esketamine nasal spray as a treatment for TRD for regulatory approval by the European Commission in Europe in October 2018.” jnj.com ↗ “Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray for Treatment-Resistant Depression” jnj.com ↗ |
| Filed | US (FDA) | — | treatment-refractory schizophrenia | 2018-09-04 | “A New Drug Application was submitted to the FDA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults” jnj.com ↗ “Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment -Resistant Depression” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | SPRAVATO | — | 2020-07-31 – 2025-01-17 | fda.gov ↗ |
| Approved | EU (EMA) | Spravato | — | 2019-12-18 | europa.eu ↗ |
| Approved | US (FDA) | SPRAVATO | — | 2019-03-05 | fda.gov ↗ |
Trials 259 · started per year
today
US approved 2019
EU approved 2019
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 011 trials | ||||||
| Phase 0 | NCT07247968 | Nov 2025 → Nov 2026 expected | depressive disorder | Min Su | Recruiting | No outcome recorded |
| Phase 0 | NCT06784388 | Jan 2025 → Dec 2027 expected | major depressive disorder | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 0 | NCT06559280 | Aug 2024 → Aug 2025 | ectopic pregnancy | Fujian Provincial Hospital | Completed | No outcome recorded |
| Phase 0 | NCT06199700 | Nov 2023 → Dec 2025 | Rett syndrome | Children's Hospital of Fudan University | Completed | No outcome recorded |
| Phase 0 | NCT06073015 | Oct 2023 → Dec 2024 | mixed anxiety and depressive disorder | Henan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT05943028 | Jul 2023 → Oct 2024 | — | bo xu | Unknown | No outcome recorded |
| Phase 0 | NCT05242692 | Jun 2022 → Aug 2025 | delirium | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Completed | No outcome recorded |
| Phase 0 | NCT06370130 | May → Dec 2022 | — | Aerospace Center Hospital | Completed | No outcome recorded |
| Phase 0 | NCT04777110 | Aug 2021 → Aug 2022 | depressive disorder | First Affiliated Hospital of Chongqing Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT04757675 | Mar → Sep 2021 | separation anxiety disorder | Eye & ENT Hospital of Fudan University | Completed | No outcome recorded |
| Phase 0 | NCT04745286 | Mar → Oct 2021 | lung disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 129 trials · 1 missed | ||||||
| Phase 1 | NCT07603596 | May 2026 → Apr 2028 expected | delirium, digestive system neoplasm | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05571176 | Jan → Jun 2023 | — | Elina Brinck | Unknown | No outcome recorded |
| Phase 1 | NCT05268497 | Sep 2022 → Jun 2023 | depressive disorder | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT05320120 | Jun 2022 → Jun 2023 | — | Rupert Lanzenberger | Completed | No outcome recorded |
| Phase 1 | NCT04587778 | Oct 2020 → Mar 2025 | major depressive disorder | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 1 | NCT04300621 | Jun → Aug 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04282746 | Feb → Aug 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03808259 | Dec 2018 → Sep 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03407872 | Dec 2017 → May 2018 | — | Celon Pharma SA | Completed | No outcome recorded |
| Phase 1 | NCT03298906 | Sep → Nov 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02919579 | Oct 2016 → Jun 2018 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 1 | NCT02857777 | Aug 2016 → Jan 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02737605 | Jul 2016 → Feb 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02682225 | Mar 2016 → Jan 2017 | substance abuse | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02674295 | Mar → Aug 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02846519 | Feb → May 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02606084 | Dec 2015 → Feb 2018 | impaired renal function disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02611505 | Nov 2015 → Feb 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02568176 | Oct 2015 → Feb 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02343289 | Jan → Apr 2015 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02345148 | Dec 2014 → Jan 2015 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02228239 | Sep → Dec 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02094378 | Jun → Aug 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02154334 | Jun → Oct 2014 | allergic rhinitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02129088 | Mar → May 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01980303 | Nov 2013 → Jan 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02060929 | Oct 2013 → Jan 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01780259 | Dec 2012 → May 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00847418 | Feb → Oct 2009 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07034950 | Jun 2025 → Jun 2028 expected | liver cancer | The First Affiliated Hospital of Xiamen University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT07034963 | Jun 2025 → Jun 2028 expected | adhesions of uterus, uterine polyp | The First Affiliated Hospital of Xiamen University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06795659 | Jun 2025 → Jan 2026 | post-traumatic stress disorder | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 1/2 | NCT06920576 | Mar → Jul 2025 overdue | chronic rhinosinusitis | The Second People's Hospital of Huai'an | Active not recruiting | No outcome recorded |
| Phase 216 trials · 4 met primary · 2 missed | ||||||
| Phase 2 | NCT06744361 | Dec 2024 → Sep 2027 expected | cardiac arrest | Christian Hassager | Recruiting | No outcome recorded |
| Phase 2 | NCT05438758 | Jan 2023 → Feb 2024 | major depressive disorder | Zylorion Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT07212946 | Oct 2022 → Oct 2024 | major depressive disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 2 | NCT05323019 | Oct 2022 → Feb 2023 | major depressive disorder | Zylorion Health | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05092152 | Oct 2021 → Oct 2023 | acute respiratory failure | Federal University of São Paulo | Completed | Missed primary |
| Phase 2 | NCT04867343 | Jun 2021 → Aug 2023 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03965871 | Mar 2019 → Jan 2021 | bipolar depression | Celon Pharma SA | Completed | No outcome recorded |
| Phase 2 | NCT03965858 | Feb 2019 → Mar 2020 | major depressive disorder | Celon Pharma SA | Completed | No outcome recorded |
| Phase 2 | NCT03185819 | Oct 2017 → Mar 2023 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT02918318 | Dec 2016 → Aug 2019 | major depressive disorder | Janssen Pharmaceutical K.K. | Completed | Missed primary |
| Phase 2 | NCT02717052 | May 2016 → Dec 2019 | depressive disorder | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT02133001 | May 2014 → Feb 2016 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01998958 | Jan 2014 → Jul 2015 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01640080 | Jun 2012 → Jun 2013 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01270282 | Feb 2011 → May 2013 | tinnitus | Auris Medical AG | Completed | No outcome recorded |
| Phase 2 | NCT00860808 | Mar 2009 → May 2011 | tinnitus | Auris Medical AG | Completed | No outcome recorded |
| Phase 2/35 trials · 2 met primary | ||||||
| Phase 2/3 | NCT06117917 | Nov 2023 → May 2024 | chronic pain syndrome | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT05160493 | Dec 2021 → Dec 2023 | chronic pain syndrome | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT05096468 | Dec 2021 → Jun 2022 | spinal cord neoplasm | Beijing Tiantan Hospital | Completed | Met primary |
| Phase 2/3 | NCT04425473 | Feb 2021 → Jun 2024 | depressive disorder | Beijing Tiantan Hospital | Completed | Met primary |
| Phase 2/3 | NCT01275547 | Jan → Jun 2011 | spinal stenosis | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 326 trials · 5 met primary · 4 missed | ||||||
| Phase 3 | NCT07716098 | Jul 2026 → Dec 2028 expected | major depressive disorder | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07227454 | Jan 2026 → Apr 2031 expected | major depressive disorder | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07153406 | Sep 2025 → Sep 2026 overdue | depressive disorder | Andalusian Public Foundation for Health Research in Seville | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05603104 | Apr 2025 → Jun 2028 expected | bipolar depression, major depressive disorder, schizophrenia | Dr. Inge Winter | Recruiting | No outcome recorded |
| Phase 3 | NCT06713616 | Jan 2025 → Dec 2030 expected | depressive disorder | Yale University | Recruiting | No outcome recorded |
| Phase 3 | NCT05973851 | Aug 2024 → Jun 2028 expected | major depressive disorder | Dr. Inge Winter | Recruiting | No outcome recorded |
| Phase 3 | NCT06161805 | Mar 2024 → Jan 2026 overdue | chronic pain syndrome, endometriosis | Reinier de Graaf Groep | Recruiting | No outcome recorded |
| Phase 3 | NCT06051227 | Jan 2024 → Aug 2026 | — | Academic Medical Center - University of Amsterdam | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04924257 | Jul 2021 → Aug 2023 | major depressive disorder | Medical University Innsbruck | Withdrawn | No outcome recorded |
| Phase 3 | NCT04476446 | Sep 2020 → Jun 2023 | depressive disorder | Janssen-Cilag, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT04338321 | Aug 2020 → Jan 2022 | major depressive disorder | Janssen-Cilag International NV | Completed | Met primary |
| Phase 3 | NCT03852160 | Dec 2019 → Jul 2021 | major depressive disorder | Janssen-Cilag International NV | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03434041 | May 2018 → Apr 2021 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03097133 | Jun 2017 → Apr 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03039192 | Jun 2017 → Dec 2018 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02782104 | Jun 2016 → Dec 2022 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02493868 | Oct 2015 → Feb 2018 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02497287 | Sep 2015 → Oct 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02422186 | Aug 2015 → Aug 2017 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 3 | NCT02417064 | Aug 2015 → Feb 2018 | — | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 3 | NCT02418585 | Aug 2015 → Jun 2017 | — | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02040207 | Jun 2014 → Dec 2016 | tinnitus | Auris Medical AG | Completed | No outcome recorded |
| Phase 3 | NCT01934010 | Jun 2014 → Jan 2017 | tinnitus | Auris Medical AG | Completed | Missed primary |
| Phase 3 | NCT01803646 | Feb 2014 → Jun 2016 | tinnitus | Auris Medical AG | Completed | Missed primary |
| Phase 3 | NCT02040194 | Jan 2014 → Dec 2017 | tinnitus | Auris Medical AG | Completed | No outcome recorded |
| Phase 3 | NCT01022840 | Feb 2009 → Mar 2012 | — | Medical University of Graz | Completed | No outcome recorded |
| Phase 480 trials · 6 met primary · 1 missed | ||||||
| Phase 4 | NCT07847255 | Oct 2026 → Apr 2028 expected | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07377981 | Sep 2026 → Jan 2029 expected | — | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07836205 | Sep 2026 → Sep 2028 expected | — | Beijing Chao Yang Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07644663 | Jun → Aug 2026 overdue | — | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07570160 | Jun 2026 → Nov 2027 expected | — | Nanjing Children's Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07120477 | Jun 2026 → Dec 2028 expected | — | University of Sao Paulo | Recruiting | No outcome recorded |
| Phase 4 | NCT07639099 | Jun 2026 → Oct 2029 expected | postpartum depression | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07576543 | Jun 2026 → Jun 2030 expected | cognitive disorder | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07610343 | Jun 2026 → Nov 2027 expected | cognitive impairment with or without cerebellar ataxia, sleep disorder | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07576517 | Jun 2026 → Jun 2029 expected | cognitive disorder | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07179913 | May → Nov 2026 expected | depressive disorder | The First Hospital of Jilin University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07479602 | Apr 2026 → Feb 2027 expected | — | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07523334 | Apr → Dec 2026 expected | delirium | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07523321 | Apr 2026 → Apr 2027 expected | — | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07525999 | Apr 2026 → Nov 2027 expected | — | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07369102 | Feb → Dec 2026 expected | major depressive disorder | University of Puerto Rico | Recruiting | No outcome recorded |
| Phase 4 | NCT07308756 | Jan 2026 → Mar 2027 expected | — | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07063108 | Dec 2025 → Jun 2026 overdue | — | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07151716 | Oct 2025 → Mar 2026 | delirium | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07145775 | Sep 2025 → Jan 2026 | — | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06968624 | Jun 2025 → Apr 2026 overdue | depressive disorder, postherpetic neuralgia | Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07053345 | Jun 2025 → Jun 2027 expected | major depressive disorder | Janssen Korea, Ltd., Korea | Recruiting | No outcome recorded |
| Phase 4 | NCT06958393 | May 2025 → Jan 2026 overdue | subacute delirium | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06853041 | May 2025 → May 2026 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 4 | NCT06859892 | Mar 2025 → Nov 2026 expected | sleep disorder | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06853431 | Mar → Nov 2025 overdue | — | Second Affiliated Hospital of Wenzhou Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT06822088 | Mar → Dec 2025 overdue | — | Jinqiao Qian | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06729892 | Jan → Apr 2025 overdue | — | bo xu | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07556172 | Jan 2025 → Jun 2026 overdue | infectious disease with sepsis | Second Affiliated Hospital of Nanchang University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06778811 | Oct 2024 → Sep 2025 overdue | sleep-wake disorder | Nanjing First Hospital, Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT05180318 | Oct → Nov 2024 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06566482 | Sep 2024 → Jul 2025 | obstructive sleep apnea syndrome | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06579937 | Sep 2024 → Sep 2025 overdue | — | Fujian Provincial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06566469 | Sep 2024 → Mar 2025 | subacute delirium | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06399185 | Jun 2024 → Apr 2027 expected | interstitial cystitis | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06303037 | Apr → Aug 2024 | — | Second Affiliated Hospital of Wenzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT06087510 | Jan 2024 → Dec 2025 overdue | chronic pain syndrome, scoliosis | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05950646 | Jan 2024 → Jan 2026 | sleep disorder | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06467513 | Jan 2024 → May 2025 | heart valve disorder | Zhang XIao Mei | Unknown | No outcome recorded |
| Phase 4 | NCT05718024 | Nov 2023 → Apr 2025 | sleep disorder | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06103760 | Oct 2023 → Sep 2025 | major depressive disorder | Royal North Shore Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05554627 | Oct 2023 | major depressive disorder | VA Office of Research and Development | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06062550 | Oct 2023 → Oct 2025 overdue | chronic pain syndrome, scoliosis | Peking University First Hospital | Active not recruiting | Missed primary |
| Phase 4 | NCT05698394 | Sep 2023 → Oct 2025 overdue | ketamine-induced biliary dilatation, postpartum depression | Peking University First Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05925283 | Jun → Nov 2023 | anxiety | Second Affiliated Hospital of Wenzhou Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05922605 | Jun 2023 → Apr 2025 | hypospadias | Tao Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT05732064 | May 2023 → Apr 2025 | breast cancer, sleep disorder | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05826327 | May 2023 → Jun 2025 | postpartum depression | Women's Hospital School Of Medicine Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT05718544 | Jan → Sep 2023 | chronic pain syndrome, scoliosis | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05670561 | Jan → Jun 2023 | hepatocellular carcinoma | The Second Affiliated Hospital of Chongqing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05643066 | Dec 2022 → Dec 2023 | — | Fujian Provincial Hospital | Completed | Met primary |
| Phase 4 | NCT05450432 | Oct 2022 → Jun 2026 overdue | major depressive disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05515822 | Oct 2022 → Apr 2024 | — | Qiang Fu | Unknown | No outcome recorded |
| Phase 4 | NCT05466708 | Aug 2022 → Dec 2024 | — | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05464979 | Aug 2022 → Jun 2024 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | Mixed |
| Phase 4 | NCT05458453 | Jul 2022 → Feb 2023 | — | The Second Affiliated Hospital of Chongqing Medical University | Completed | Met primary |
| Phase 4 | NCT05416073 | Jun 2022 → Apr 2023 | hepatocellular carcinoma | The Second Affiliated Hospital of Chongqing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05414006 | Jun → Aug 2022 | — | The Second Affiliated Hospital of Chongqing Medical University | Completed | Met primary |
| Phase 4 | NCT05422001 | May 2022 → Aug 2023 | substance-related disorder | University of Aarhus | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05289050 | Apr 2022 → Sep 2024 | — | Ling Dong | Unknown | Met primary |
| Phase 4 | NCT05299866 | Apr 2022 → May 2024 | — | Ling Dong | Unknown | No outcome recorded |
| Phase 4 | NCT06398834 | Mar 2022 → Oct 2023 | — | Second People's Hospital of Hefei City | Completed | Mixed |
| Phase 4 | NCT05229913 | Feb → Sep 2022 | postpartum depression | Qinghai University | Unknown | No outcome recorded |
| Phase 4 | NCT04964219 | Feb 2022 → Apr 2025 | — | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06574945 | Jan 2022 | — | Qian Wu | Completed | No outcome recorded |
| Phase 4 | NCT04597320 | Jan → Feb 2022 | — | Peking University | Completed | No outcome recorded |
| Phase 4 | NCT05011214 | Sep → Dec 2021 | — | Eye & ENT Hospital of Fudan University | Unknown | No outcome recorded |
| Phase 4 | NCT04548973 | Sep 2021 → Sep 2022 | — | Women's Hospital School Of Medicine Zhejiang University | Completed | No outcome recorded |
| Phase 4 | NCT04843982 | Jul 2021 → Jan 2026 | immunodeficiency disease, infectious disease with sepsis, inflammatory disease | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Terminated | No outcome recorded |
| Phase 4 | NCT04829318 | Apr 2021 → Jul 2024 | major depressive disorder | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04791059 | Apr 2021 → Sep 2022 | scoliosis | Peking University First Hospital | Completed | Met primary |
| Phase 4 | NCT04664530 | Nov 2020 → Jun 2022 | postherpetic neuralgia | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04599855 | Nov 2020 → Jan 2024 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 4 | NCT05506787 | Sep 2020 → Feb 2022 | Crohn disease, depressive disorder | Jinling Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT04682782 | Jul → Dec 2020 | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT03421275 | Dec 2017 → Dec 2022 | — | Anna Meuronen, MD | Unknown | No outcome recorded |
| Phase 4 | NCT02624401 | Jan 2016 → Mar 2017 | — | University of Turku | Completed | No outcome recorded |
| Phase 4 | NCT00209885 | Oct 2005 → ? | cholecystolithiasis | Hvidovre University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00209872 | Oct 2005 → ? | — | Hvidovre University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00115102 | Mar 2004 → Oct 2005 | tooth hard tissue disease | University of Aarhus | Completed | No outcome recorded |
| Phase not applicable87 trials · 5 met primary · 1 missed | ||||||
| — | NCT07702240 | Jul 2026 → Mar 2028 expected | biliary tract disorder | Ren Da | Not yet recruiting | No outcome recorded |
| — | NCT07665099 | Jul 2026 → Jan 2027 expected | cognitive disorder | Xijing Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07699523 | Jun 2026 → Jun 2027 expected | electroencephalographic peculiarity: fronto-precentral beta wave groups | China-Japan Friendship Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07641673 | Jun 2026 → May 2027 expected | — | The Second Hospital of Anhui Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07625826 | Jun 2026 → May 2027 expected | — | The Second Hospital of Anhui Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07324057 | Apr 2026 → Feb 2027 expected | autism spectrum disorder | Sun Fei | Recruiting | No outcome recorded |
| — | NCT07315074 | Mar → Dec 2026 expected | circadian rhythm sleep disorder | Zhuan Zhang | Recruiting | No outcome recorded |
| — | NCT07374458 | Feb → Dec 2026 expected | — | Nanjing First Hospital, Nanjing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07374198 | Jan 2026 overdue | anxiety, breast cancer, depressive disorder | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07374211 | Jan 2026 overdue | anxiety, breast cancer, depressive disorder | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07367542 | Jan 2026 → Feb 2027 expected | anxiety, breast cancer, depressive disorder | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06468436 | Nov 2025 → Dec 2029 expected | delirium | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07422519 | Sep 2025 → Dec 2026 expected | dysthymic disorder, major depressive disorder | Hospital Universitari Vall d'Hebron Research Institute | Recruiting | No outcome recorded |
| — | NCT06788444 | Sep 2025 → Dec 2026 expected | irritable bowel syndrome | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT07230171 | Sep 2025 → Jun 2027 expected | fibromyalgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT07131033 | Sep 2025 → Jun 2026 | — | The Second People's Hospital of Huai'an | Completed | No outcome recorded |
| — | NCT07062601 | Jul → Nov 2025 overdue | tonsillitis | Anqing Municipal Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07002723 | Jun 2025 → Jun 2026 overdue | — | Peking University Shenzhen Hospital | Recruiting | No outcome recorded |
| — | NCT07125573 | May 2025 → Mar 2026 overdue | lung neoplasm | First Affiliated Hospital of Kunming Medical University | Enrolling by invitation | No outcome recorded |
| — | NCT06914180 | Apr 2025 → Apr 2026 overdue | postherpetic neuralgia | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06914193 | Apr 2025 → Jul 2026 overdue | postherpetic neuralgia | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06890897 | Apr 2025 → Jun 2026 overdue | trigeminal neuralgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06896994 | Apr 2025 → Apr 2026 overdue | postherpetic neuralgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06914206 | Apr 2025 → Apr 2026 overdue | herpes zoster | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06900205 | Apr 2025 → Mar 2026 | delirium, sleep disorder | RenJi Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT06976996 | Mar → Dec 2025 overdue | — | Northern Jiangsu People's Hospital | Active not recruiting | No outcome recorded |
| — | NCT07002801 | Mar 2025 → Jun 2026 overdue | digestive system disorder | Harbin Medical University | Recruiting | No outcome recorded |
| — | NCT06817239 | Feb 2025 → Jun 2027 expected | delirium | Nanfang Hospital, Southern Medical University | Recruiting | No outcome recorded |
| — | NCT06789185 | Feb → May 2025 | — | Qiu jinpeng | Completed | No outcome recorded |
| — | NCT06773143 | Dec 2024 → Dec 2026 expected | female breast carcinoma, insomnia | Nanjing First Hospital, Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT06658132 | Oct 2024 → Feb 2025 | Parkinson disease | RenJi Hospital | Completed | No outcome recorded |
| — | NCT06607029 | Oct 2024 → Dec 2025 overdue | supratentorial cancer | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06617039 | Oct 2024 → Jul 2025 overdue | — | Northern Jiangsu People's Hospital | Active not recruiting | No outcome recorded |
| — | NCT06624878 | Oct 2024 → Jan 2026 | depressive disorder, ovarian cancer | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| — | NCT06608030 | Sep 2024 → Apr 2025 | cardiac valvular defect, mixed anxiety and depressive disorder | Chinese PLA General Hospital | Completed | Met primary |
| — | NCT06531837 | Aug 2024 → Jan 2026 overdue | chronic pain syndrome | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06543563 | Aug 2024 → Dec 2025 overdue | Parkinson disease | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06530706 | Aug 2024 → May 2025 | anxiety | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| — | NCT06493396 | Aug 2024 → Aug 2025 overdue | sleep disorder | Beijing Friendship Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06432322 | Jun 2024 → Mar 2025 | depressive disorder | University of Oxford | Completed | No outcome recorded |
| — | NCT06431386 | Jun 2024 → Sep 2025 | bipolar disorder, major depressive disorder | The Royal's Institute of Mental Health Research | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT06451627 | Jun 2024 → Dec 2025 | sleep disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| — | NCT06473285 | Jun 2024 → May 2025 | — | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| — | NCT06389344 | May 2024 → Dec 2025 overdue | cognitive disorder | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06414941 | May → Oct 2024 | — | Anqing Municipal Hospital | Unknown | No outcome recorded |
| — | NCT06430645 | May → Oct 2024 overdue | — | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06355180 | Apr 2024 → Jun 2025 | depressive disorder | Capital Medical University | Completed | No outcome recorded |
| — | NCT06294639 | Mar 2024 → Mar 2025 | — | Air Force Military Medical University, China | Unknown | No outcome recorded |
| — | NCT06305221 | Mar 2024 → Mar 2025 | postgastrectomy syndrome | Beijing Friendship Hospital | Unknown | No outcome recorded |
| — | NCT06310785 | Feb → Oct 2024 | — | Hui Xu | Completed | No outcome recorded |
| — | NCT06199011 | Jan 2024 → Oct 2025 | depressive disorder | The Second Hospital of Anhui Medical University | Unknown | No outcome recorded |
| — | NCT06300944 | Dec 2023 → Oct 2024 | — | General Hospital of Ningxia Medical University | Completed | No outcome recorded |
| — | NCT06003218 | Oct 2023 → Sep 2024 | liver cancer | Peking University First Hospital | Completed | No outcome recorded |
| — | NCT05960942 | Aug → Oct 2023 | autism spectrum disorder | The Second Hospital of Nanjing Medical University | Completed | No outcome recorded |
| — | NCT05951465 | Jul → Sep 2023 | autism spectrum disorder | The Second Hospital of Nanjing Medical University | Completed | No outcome recorded |
| — | NCT07064408 | Jun 2023 → Nov 2024 | — | Hebei Medical University Fourth Hospital | Completed | No outcome recorded |
| — | NCT06778460 | May 2023 → Mar 2027 expected | chronic pain syndrome | West China Hospital | Recruiting | No outcome recorded |
| — | NCT05809804 | Apr → Jul 2023 | — | Yangzhou University | Unknown | No outcome recorded |
| — | NCT05715671 | Mar → Nov 2023 | — | Zhuan Zhang | Completed | Met primary |
| — | NCT05551910 | Jan 2023 → Jan 2025 | — | The First Hospital of Jilin University | Unknown | Met primary |
| — | NCT05497492 | Nov 2022 → Dec 2023 | — | Beijing Friendship Hospital | Unknown | No outcome recorded |
| — | NCT05242081 | Jul → Dec 2022 | substance-related disorder | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| — | NCT05283408 | Apr 2022 → Mar 2023 | — | Anqing Municipal Hospital | Completed | No outcome recorded |
| — | NCT05321160 | Mar 2022 → May 2023 | — | Eye & ENT Hospital of Fudan University | Completed | No outcome recorded |
| — | NCT05304559 | Mar → Apr 2022 | — | Yangzhou University | Unknown | No outcome recorded |
| — | NCT05289440 | Mar → Sep 2022 | — | Anqing Municipal Hospital | Completed | No outcome recorded |
| — | NCT05155969 | Dec 2021 | — | Anshi Wu | Unknown | No outcome recorded |
| — | NCT05752409 | Oct 2021 → Nov 2023 | — | Eye & ENT Hospital of Fudan University | Unknown | No outcome recorded |
| — | NCT05060068 | Oct 2021 → Jul 2024 | breast cancer | The Second Hospital of Anhui Medical University | Completed | No outcome recorded |
| — | NCT05016128 | Aug → Dec 2021 | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT04938713 | Jul 2021 → May 2022 | fibromyalgia | Centre Hospitalier Universitaire de Charleroi | Unknown | No outcome recorded |
| — | NCT07528651 | Jun 2021 → Jun 2022 | — | Erasme University Hospital | Completed | No outcome recorded |
| — | NCT04873479 | May 2021 → Dec 2022 | acute lung injury, infectious disease with sepsis | Tianjin Nankai Hospital | Unknown | No outcome recorded |
| — | NCT04847245 | May 2021 → Dec 2022 | chronic pain syndrome, major depressive disorder | Peking University | Unknown | No outcome recorded |
| — | NCT04860661 | May 2021 → Mar 2024 | postpartum depression | Ailin Luo | Completed | Met primary |
| — | NCT05341375 | Apr 2021 → Jan 2022 | — | The First Hospital of Qinhuangdao | Completed | No outcome recorded |
| — | NCT04850937 | Feb → Apr 2021 | depressive disorder | Yangzhou University | Completed | No outcome recorded |
| — | NCT04691076 | Dec 2020 → Dec 2021 | — | Tianjin Union Medical Center | Unknown | No outcome recorded |
| — | NCT04657107 | Dec 2020 → Dec 2021 | depressive disorder | Beijing Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
| — | NCT04553536 | Nov 2020 → Jun 2023 | poisoning | Second Hospital of Shanxi Medical University | Unknown | No outcome recorded |
| — | NCT04436250 | Oct 2020 → Aug 2024 | fibromyalgia | Grand Hôpital de Charleroi | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04613869 | Aug 2020 → Aug 2021 | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT04399070 | Aug → Dec 2020 | bipolar depression, major depressive disorder | Yan Qiu | Unknown | No outcome recorded |
| — | NCT03927378 | Jun 2020 → Aug 2022 | postpartum depression | Peking University First Hospital | Completed | No outcome recorded |
| — | NCT04414943 | Jun 2020 → Aug 2022 | postpartum depression | Peking University First Hospital | Completed | Met primary |
| — | NCT03756961 | May 2019 → May 2028 expected | obesity disorder | Göteborg University | Recruiting | Missed primary |
| — | NCT01394757 | Aug 2011 → Aug 2012 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03829579 | — | major depressive disorder | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| Comparator or background therapy40 trials | ||||||
| Phase 1 | NCT06726382 Comparator | Dec 2024 → Apr 2025 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 2 | NCT07317206 Comparator | Dec 2025 → Jun 2026 overdue | post-traumatic stress disorder | University of Sao Paulo | Recruiting | No outcome recorded |
| Phase 2 | NCT05635955 Background | Aug → Sep 2022 | — | Maternal and Child Health Hospital of Hubei Province | Completed | No outcome recorded |
| Phase 2 | NCT04666623 Comparator | Nov 2020 → Oct 2023 | — | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |
| Phase 2 | NCT03231683 Comparator | Mar 2014 → May 2016 | — | KK Women's and Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05839366 Comparator | May 2023 → Oct 2024 | infectious disease with sepsis | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT06613243 Comparator | Oct → Dec 2024 | — | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06278779 Comparator | Jun 2024 → Apr 2027 expected | — | The George Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05095857 Comparator | Sep 2023 → Sep 2028 expected | acquired aneurysmal subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT05655754 Comparator | Nov 2022 → Mar 2026 | depressive disorder | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT04303325 Comparator | Oct 2021 → Oct 2024 overdue | depressive disorder | China Medical University, China | Recruiting | No outcome recorded |
| Phase 4 | NCT04459377 Comparator | Feb 2017 → Mar 2022 | — | Dalarna County Council, Sweden | Completed | No outcome recorded |
| Phase 4 | NCT02994173 Comparator | Feb 2017 → Nov 2019 | — | Turku University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00534586 Comparator | Dec 2005 → May 2007 | — | Technical University of Munich | Completed | No outcome recorded |
| — | NCT07597486 Comparator | May 2026 → Jun 2027 expected | — | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07560722 Comparator | May 2026 → May 2027 expected | intrahepatic cholestasis of pregnancy | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07584902 Comparator | Apr → Oct 2026 expected | hepatobiliary disorder | Gang Chen | Not yet recruiting | No outcome recorded |
| — | NCT07317232 Comparator | Dec 2025 → Jun 2026 overdue | — | University of Sao Paulo | Recruiting | No outcome recorded |
| — | NCT07317219 Comparator | Dec 2025 → Jun 2026 overdue | — | University of Sao Paulo | Recruiting | No outcome recorded |
| — | NCT07084753 Comparator | Jul → Sep 2025 overdue | obesity disorder | IVO JURISIC | Not yet recruiting | No outcome recorded |
| — | NCT07050212 Comparator | Apr 2025 → Mar 2026 overdue | — | Maternal and Child Health Hospital of Hubei Province | Recruiting | No outcome recorded |
| — | NCT06367218 Background | Oct 2024 → Jul 2026 overdue | — | Tongji Hospital | Recruiting | No outcome recorded |
| — | NCT06388824 Comparator | May → Nov 2024 | sleep disorder | Tianjin Medical University General Hospital | Completed | No outcome recorded |
| — | NCT06284668 Comparator | Mar 2024 → May 2025 | sleep disorder | Tianjin Medical University General Hospital | Completed | No outcome recorded |
| — | NCT06108830 Comparator | Dec 2023 → Nov 2024 overdue | sleep disorder | Tianjin Medical University General Hospital | Recruiting | No outcome recorded |
| — | NCT05964985 Comparator | Aug 2023 → Jan 2024 | — | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| — | NCT05811221 Comparator | Apr → May 2023 | — | Yangzhou University | Unknown | No outcome recorded |
| — | NCT05577962 Background | Feb → Sep 2023 | — | Beijing Friendship Hospital | Unknown | No outcome recorded |
| — | NCT05686863 Background | Jan → Jul 2023 | — | Tongji Hospital | Completed | Met primary |
| — | NCT05603975 Comparator | Dec 2022 → Apr 2025 | — | Shenzhen Second People's Hospital | Unknown | No outcome recorded |
| — | NCT05212571 Comparator | Apr 2022 → Oct 2026 expected | complex regional pain syndrome | Erasmus Medical Center | Enrolling by invitation | No outcome recorded |
| — | NCT05122338 Comparator | Dec 2021 → May 2022 | — | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| — | NCT05132595 Comparator | Nov 2021 → Jul 2022 | subjective cognitive decline | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| — | NCT05582135 Comparator | May → Aug 2021 | dystocia | Xuanhan County People's Hospital | Completed | No outcome recorded |
| — | NCT04843462 Background | Apr 2021 → Apr 2023 | major depressive disorder | Lukas Pezawas | Unknown | No outcome recorded |
| — | NCT04698434 Comparator | Jan → Feb 2021 | phimosis | Yangzhou University | Completed | No outcome recorded |
| — | NCT04643132 Comparator | Dec 2020 → Nov 2021 | — | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| — | NCT05602428 Background | Jan 2020 → May 2021 | — | Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine | Completed | No outcome recorded |
| — | NCT02543385 Comparator | Jun 2014 → Jun 2015 | — | KK Women's and Children's Hospital | Withdrawn | No outcome recorded |
| — | NCT01506921 Comparator | May 2011 → Feb 2012 | — | Lund University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2025-01-21 | Janssen Research & Development, LLC | Regulatory SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression jnj.com ↗ |
| 2025-01-21 | Janssen Research & Development, LLC | Regulatory SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression jnj.com ↗ |
| 2024-10-24 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress jnj.com ↗
New five-year, real-world safety data from nearly 35,000 adults treated with SPRAVATO®, building on more than a decade of research and reinforcing its well-studied, consistent safety profile (Poster 151). |
| 2024-10-24 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress jnj.com ↗ |
| 2024-07-22 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO®(esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). |
| 2024-07-22 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO(esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). |
| 2024-05-29 | Janssen Research & Development, LLC | Results Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes jnj.com ↗
Additional data presented at ASCP includes positive topline results from the placebo-controlled Phase 4 TRD4005 study of SPRAVATO®(esketamine) CIII nasal spray as a monotherapy in patients with TRD, which met both its primary and secondary endpoints. |
| 2024-05-29 | Janssen Research & Development, LLC | Results Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes jnj.com ↗ |
| 2023-11-13 | HolsboerMaschmeyer NeuroChemie GmbH | Results Head-to-head Trial of Prolonged-Release Oral Ketamine Formulation, KET01, and Intranasal SPRAVATO®, Finds Less Incidence of Dissociation or Cardiovascular Effects with Oral Treatment, at doses used for Treatment-Resistant Depression hmnc-brainhealth.com ↗
Due to its unique metabolite profile, the incidence of dissociation with KET01 was very low and statistically significantly lower relative to SPRAVATO®, pointing to a clinically meaningful difference, which could offer the potential for a safe at-home unsupervised administration. |
| 2023-10-04 | Janssen Research & Development, LLC | Results SPRAVATO® (esketamine) Demonstrates Superior Efficacy Compared to Quetiapine Extended-Release in Treatment-Resistant Major Depressive Disorder jnj.com ↗
SPRAVATO®-treated patients were also 1.55 times as likely to stay relapse-free up to 32 weeks after achieving remission at Week 8, without treatment discontinuation, in comparison to those treated with quetiapine XR (21.7% vs. 14.1%, respectively). |
| 2021-02-08 | Janssen Research & Development, LLC | Regulatory SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of SPRAVATO®(esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency. |
| 2021-02-08 | Janssen Research & Development, LLC | Regulatory SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder jnj.com ↗
SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder |
| 2021-01-08 | Celon Pharma SA | Results Pozytywne wyniki II fazy klinicznej esketaminy DPI Celon Pharma (Falkieri) w lekoopornej depresji dwubiegunowej. celonpharma.com ↗
W badaniu II fazy esketaminy w depresji dwubiegunowej osiągnięto zakładany pierwszorzędowy punkt końcowy, definiowany jako znacząca, istotna statystycznie i klinicznie redukcja objawów depresji na podstawie skali MADRS w porównaniu z placebo w 2 tygodniu, we wszystkich testowanych dawkach. |
| 2020-12-11 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for SPRAVATO®▼ (Esketamine Nasal Spray) for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder jnj.com ↗
Janssen Receives Positive CHMP Opinion for SPRAVATO®▼ (Esketamine Nasal Spray) for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder |
| 2020-08-03 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior jnj.com ↗
the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO®(esketamine) CIII nasal spray |
| 2020-08-03 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior jnj.com ↗ |
| 2020-01-15 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of SPRAVATO®▼ (Esketamine) Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO®▼(esketamine) nasal spray. |
| 2020-01-15 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of SPRAVATO®▼ (Esketamine) Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO®▼ (esketamine) nasal spray. |
| 2019-12-19 | Janssen Research & Development, LLC | Regulatory SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder jnj.com ↗
SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder |
| 2019-10-18 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for Spravato® (Esketamine) Nasal Spray for Adults with Treatment-Resistant Major Depressive Disorder jnj.com ↗ |
| 2019-10-18 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for SPRAVATO® (ESKETAMINE) Nasal Spray for Adults with Treatment Resistant Major Depressive Disorder jnj.com ↗
JANSSEN RECEIVES POSITIVE CHMP OPINION FOR SPRAVATO® (ESKETAMINE) NASAL SPRAY FOR ADULTS WITH TREATMENT-RESISTANT MAJOR DEPRESSIVE DISORDER |
| 2019-10-02 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA for SPRAVATO® (esketamine) CIII Nasal Spray for the Rapid Reduction of Depressive Symptoms in Adults with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent jnj.com ↗ |
| 2019-10-02 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA for SPRAVATO® (esketamine) CIII Nasal Spray for the Rapid Reduction of Depressive Symptoms in Adults with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent jnj.com ↗
Janssen Submits Supplemental New Drug Application to U.S. FDA for SPRAVATO® (esketamine) CIII Nasal Spray for the Rapid Reduction of Depressive Symptoms in Adults with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent |
| 2019-09-09 | Janssen Research & Development, LLC | Results New Data from Esketamine Nasal Spray Phase 3 Studies Showed Rapid Reduction of Depressive Symptoms in Adult Patients with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent jnj.com ↗
In both studies, esketamine nasal spray 84 mg plus SOC showed clinically meaningful and statistically significant superiority (p=0.006) over placebo plus SOC in rapidly reducing symptoms of major depressive disorder. |
| 2019-03-05 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of SPRAVATOTM (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). |
| 2019-02-13 | Celon Pharma SA | Regulatory Celon Pharma na dobrej drodze po światowy rynek leku na depresję lekooporną celonpharma.com ↗ |
| 2019-02-12 | Janssen Research & Development, LLC | Regulatory FDA Advisory Committee Recommends Approval of SPRAVATOTM (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression jnj.com ↗ |
| 2018-10-10 | Janssen Research & Development, LLC | Regulatory Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray for Treatment-Resistant Depression jnj.com ↗
Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray for Treatment-Resistant Depression |
| 2018-09-21 | Janssen Research & Development, LLC | Results Janssen Announces Results of Esketamine Nasal Spray Phase 3 Study in Patients with Treatment-Resistant Depression jnj.com ↗
The study did not demonstrate statistical significance for the primary endpoint, change in a depression severity rating scale score from baseline to four weeks, for esketamine 84 mg plus oral antidepressant compared to oral antidepressant plus placebo. |
| 2018-09-04 | Janssen Research & Development, LLC | Regulatory Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. |
| 2018-05-05 | Janssen Research & Development, LLC | Results New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the results from two Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. |
| 2016-08-16 | Janssen Research & Development, LLC | Regulatory Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide jnj.com ↗
Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for esketamine, an investigational antidepressant medication, for the indication of major depressive disorder with imminent risk for suicide. |
All press releases naming this drug 40 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 308 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Esketamine | “Dexmedetomidine-esketamine combination (1 μg/mL dexmedetomidine and 0.5 mg/mL esketamine) will be administered after anesthesia induction, firstly as a loading dose at a rate...” NCT07576517 ↗248“BACKGROUND: The objective of this study was to evaluate the efficacy and safety of esketamine hydrochloride injection (HR020602) in combination with propofol for the induction...” PMID 41545823 ↗ Jan 2026 “The patients received a single intravenous infusion of esketamine (0.2 mg/kg), which was added to 50 ml of normal saline and administered via a micro-infusion pump over 40 minutes.” NCT06968624 ↗ “Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.” NCT06389344 ↗ “Esketamine and propofol will be prepared shortly before injection by the nurse anesthetist as follows: 4 ml esketamine 25mg/ml, 6ml NaCl (0,9%), 10ml propofol (10mg/ml).” NCT05655754 ↗ “Esketamine combined with pregabalin on acute postoperative pain in patients undergoing resection of spinal neoplasms: study protocol for a randomized controlled trial.” PMID 36841794 ↗ Feb 2023 “1. experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn.” NCT07247968 ↗ “anaesthesia will be induced with 1.5-2.5 mg/kg propofol, 0.3-0.5 mg/kg esketamine, and 0.6-1.0 mg/kg rocuronium” NCT07603596 ↗ “lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly” NCT05577962 ↗ “The investigator will use esketamine, dexmetopidine, and local anesthesia to control perioperative pain.” NCT06607029 ↗ “Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week” NCT07153406 ↗ |
| Known as | (R,S)-ketamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02717052 ↗ |
| Known as | AM-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02040207 ↗ |
| Known as | ESK | “After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml),...” NCT07523321 ↗6“To investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).” NCT06574945 ↗ “After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml)” NCT07525999 ↗ “Esketamine nasal spray (ESK) has been studied in several long-term trials of patients with TRD” PMID 37558912 ↗ Aug 2023 “Esketamine (ESK) shows potential as a rapid-acting analgesic in FM patients” PMID 42170615 ↗ May 2026 “esketamine nasal spray (ESK) plus newly initiated oral antidepressant (OAD)” PMID 38557430 ↗ Apr 2024 “Esketamine (ESK) nasal spray” PMID 37568081 ↗ Aug 2023 |
| Known as | Esketamin | “Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml” NCT05422001 ↗ |
| Known as | esketamine hydrochloride | “BACKGROUND: The objective of this study was to evaluate the efficacy and safety of esketamine hydrochloride injection (HR020602) in combination with propofol for the induction...” PMID 41545823 ↗ Jan 20269“OBJECTIVE: To assess the efficacy, safety, and dose-response of intranasal esketamine hydrochloride in patients with treatment-resistant depression (TRD).” PMID 29282469 ↗ Feb 2018 “The new analgesic anesthetic esketamine hydrochloride was launched in China last year” NCT04613869 ↗ “Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato]” NCT05464979 ↗ “Drug: Esketamine hydrochloride” NCT06199700 ↗ “Drug: esketamine hydrochloride” NCT06744361 ↗ “Esketamine hydrochloride” NCT05973851 ↗ “Esketamine hydrochloride” NCT02345148 ↗ |
| Known as | Esketamine Kalceks 5 mg/ml | “Study drug dose (Esketamine Kalceks 5 mg/ml, 28 mg) p.o. at 9.00 a.m. on the study day.” NCT06726382 ↗ |
| Known as | HR020602 | “BACKGROUND: The objective of this study was to evaluate the efficacy and safety of esketamine hydrochloride injection (HR020602) in combination with propofol for the induction...” PMID 41545823 ↗ Jan 2026 |
| Known as | JNJ-54135419 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04282746 ↗ |
| Known as | ketamine | “intranasal esketamine (ketamine) for the treatment of posttraumatic stress disorder (PTSD)” NCT06795659 ↗1“Intranasal ketamine (Esketamine)” NCT05438758 ↗ |
| Known as | Ketanest | “In this investigator-initiated randomised, double-blinded, crossover study, adult healthy volunteers will be randomised to receive, as 60-second iv bolus injections on two...” NCT01506921 ↗ |
| Known as | low dose ketamine | “Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml” NCT05422001 ↗ |
| Known as | right ketamine | “Esketamine, also known as right ketamine, has pharmacological characteristics similar to racemic ketamine while enhancing analgesic and sedative effects, helping to reduce...” NCT06559280 ↗ |
| Known as | S-ketamine | “A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total...” NCT07084753 ↗42“Ketamine and its enantiomer S-ketamine (esketamine) are promising candidates to produce a rapid-onset antidepressant effect in treatment-resistant depression.” PMID 29736744 ↗ May 2018 “Patients were randomly assigned to receive an intravenous infusion of S(+)-ketamine (0.3 mg/kg/h) or 0.9% sodium chloride solution.” PMID 41209744 ↗ Nov 2025 “the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies.” NCT04425473 ↗ “Participants will receive (S)-ketamine administered sublingually through OTF 1.” NCT04300621 ↗ |
| Known as | Spravato | “BACKGROUND: Esketamine nasal spray (Spravato) in conjunction with oral antidepressants (ADs) is approved in the European Union, United States, and other markets for...” PMID 34696742 ↗ Oct 20215“Intranasal esketamine (Spravato®), administered under medical supervision in accordance with FDA guidelines for treatment-resistant depression.” NCT07369102 ↗ “Spravato nasal spray is the only esketamine product on the market used for the treatment of depression” NCT06726382 ↗ “Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato]” NCT05464979 ↗ “Spravato® (Esketamine) will be given intranasally.” NCT06713616 ↗ “56mg esketamine (2x Spravato® 28 mg nasal spray)” NCT05320120 ↗ |
| Known as | Spravato (for depression), Ketanest (for anesthesia) | “Spravato (for depression), Ketanest (for anesthesia)” NCT05554627 ↗ |
| Action | Inhibit | “NMDA receptor antagonist AM-101” PMID 28608739 ↗ Jun 2017 |
| Modality | Other / unclassified | “Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses.” NCT05155969 ↗ |
| Route | Intranasal | “after nasal application” NCT00847418 ↗ |