Product Description
Esketamine (SPRAVATO CIII nasal spray) is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It has a novel mechanism of action, meaning it works differently than currently available therapies for major depressive disorder (MDD). Esketamine is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. (Sourced from: https://www.jnj.com/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)
Mechanisms of Action: NMDA Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous,Nasal
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: Depressive Disorder | Depressive Disorder, Major | Depressive Disorder, Treatment-Resistant | Suicidality
Known Adverse Events: Suicidality | Dizziness | Lethargy | Vertigo
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 15
Highest Development Phases
Phase 3: Anesthesia Related|Asthma|Depressive Disorder|Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant|Schizophrenia
Phase 2: Suicidality
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CESAR | P3 |
Unknown Status |
Depressive Disorder, Major |
2029-01-15 |
|
| Ketamine in negative symptoms | P3 |
Active, not recruiting |
Schizophrenia |
2024-11-03 |
|
| BT-KTM-I-III-01 | P3 |
Completed |
Anesthesia Related |
2024-03-19 |
|
| 2020-000784-23 | P3 |
Active, not recruiting |
Depressive Disorder, Major |
2023-08-05 |