How many clinical trials are studying Esketamine hydrochloride?

3 recruiting trials in our tracked data involve Esketamine hydrochloride.

What conditions is Esketamine hydrochloride being studied for?

In our tracked recruiting trials, Esketamine hydrochloride is being studied in trials for Depression, Major Depressive Disorder, Bipolar Depression.

Esketamine hydrochloride: clinical trials recruiting now

Q: Is Esketamine hydrochloride FDA-approved?

Yes. According to the FDA drug label available through openFDA, Esketamine hydrochloride is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Esketamine hydrochloride appears in the FDA drug-label database. Marketed as Spravato.
Boxed warning: The FDA label for Esketamine hydrochloride carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant SPRAVATO is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated for the treatment of: Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant. ( 1 ) Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. ( 1 ) Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. ( 1 ) SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. ( 1 ) Limitations of Use The effectiveness of SPRAVATO in…

FDA label via openFDA

Phase breakdown

Phase 3 3

Conditions being studied

Condition	Trials
Depression	2
Major Depressive Disorder	2
Bipolar Depression	1
Bipolar disorder	1
Chronic Pelvic Pain Syndrome	1
Endometriosis	1
Schizophrenia	1
Schizophrenia and Related Disorders	1
Treatment Resistant Depression	1

Recruiting trials involving Esketamine hydrochloride

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
NCT06161805 · Phase: Phase 3 · Ages: 18 Years to 50 Years · Sex: Female · 1 location
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT05603104 · Phase: Phase 3 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
NCT05973851 · Phase: Phase 3 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 12 locations

Common questions

Is Esketamine hydrochloride FDA-approved?

Yes, marketed as Spravato. Its FDA label carries a boxed warning.

How many recruiting trials involve Esketamine hydrochloride?

3 recruiting trials across 9 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.