Overview
Major depressive disorder (MDD) is a significant cause of disability worldwide and the most common illness preceding suicide. On March 5, 2019, the nasal spray drug, esketamine, also known as Spravato (by Janssen Pharmaceuticals), was approved by the FDA for treatment-resistant major depression. Esketamine is the s-enantiomer of Ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first time that the FDA has approved esketamine for any use. The FDA approved ketamine (Ketalar) in 1970. Esketamine may prove to be a promising treatment for patients diagnosed with major depressive disorder who have not experienced an improvement in symptoms despite treatment with various medications and therapies. The intranasal route of administration for this drug allows for easy administration and a fast onset of action, which sets it apart from many other antidepressant agents that may take several weeks to take effect.
Background
Major depressive disorder (MDD) is a significant cause of disability worldwide and the most common illness preceding suicide. On March 5, 2019, the nasal spray drug, esketamine, also known as Spravato (by Janssen Pharmaceuticals), was approved by the FDA for treatment-resistant major depression. Esketamine is the s-enantiomer of Ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first time that the FDA has approved esketamine for any use. The FDA approved ketamine (Ketalar) in 1970. Esketamine may prove to be a promising treatment for patients diagnosed with major depressive disorder who have not experienced an improvement in symptoms despite treatment with various medications and therapies. The intranasal route of administration for this drug allows for easy administration and a fast onset of action, which sets it apart from many other antidepressant agents that may take several weeks to take effect.
Indication
Esketamine is indicated in combination with an oral antidepressant for the treatment of treatment-resistant depression in adults. It is also indicated for the treatment of depressive symptoms in adults with major depressive disorder experiencing acute suicidal ideation or behaviour.
Associated Conditions
- Major Depressive Disorder (MDD)
- Major depressive disorder, recurrent episode
- Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/03 | Not Applicable | Recruiting | Maternal and Child Health Hospital of Hubei Province | ||
2025/06/04 | Not Applicable | Recruiting | Peking University Shenzhen Hospital | ||
2025/06/03 | N/A | Recruiting | |||
2025/05/16 | Not Applicable | Active, not recruiting | Northern Jiangsu People's Hospital | ||
2025/05/06 | Phase 4 | Not yet recruiting | Qianfoshan Hospital | ||
2025/04/10 | Phase 1 | Active, not recruiting | The Second People's Hospital of Huai'an | ||
2025/04/06 | Not Applicable | Not yet recruiting | Beijing Tiantan Hospital | ||
2025/04/06 | Not Applicable | Not yet recruiting | Beijing Tiantan Hospital | ||
2025/03/28 | Not Applicable | Withdrawn | |||
2025/03/26 | Not Applicable | Recruiting | Beijing Tiantan Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Pharmaceuticals Inc. | 50458-028 | NASAL | 28 mg in 0.2 mL | 10/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/18/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SPRAVATO NASAL SPRAY 28MG/VIAL | SIN16033P | SPRAY | 28mg/vial | 10/27/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Esketamine Hydrochloride Nasal Spray | 国药准字HJ20230041 | 化学药品 | 鼻用制剂 | 5/15/2023 | |
| Esketamine Hydrochloride Injection | 国药准字H20247040 | 化学药品 | 注射剂 | 3/5/2024 | |
| Esketamine Hydrochloride Injection | 国药准字H20244192 | 化学药品 | 注射剂 | 6/28/2024 | |
| Esketamine Hydrochloride Injection | 国药准字H20193336 | 化学药品 | 注射剂 | 11/18/2019 | |
| Esketamine Hydrochloride Injection | 国药准字H20244027 | 化学药品 | 注射剂 | 6/18/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution | 311827 | Medicine | A | 3/9/2021 |