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Drug

Esketamine hydrochloride

Approved · FDA / EMA
Late-stage development

Also known as Spravato, esketamine (as hydrochloride), esketamine HCl.

RxNorm2119366
8
Active clinical trials
19
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)

Regulatory2026-06-24FDA

Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)

Regulatory2026-04-13FDA

Esketamine With or Without Psychedelic Preparation and Integration for Treatment-Resistant Depression: A Randomized Controlled Trial

Clinical trial2026-01-27Results expected Q4 2026 · ClinicalTrials.gov

Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)

Regulatory2026-01-23FDA

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Clinical trial2026-01-22Results expected Q2 2028 · ClinicalTrials.gov

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study

Clinical trial2026-01-01Primary completion · ClinicalTrials.gov

An Exploratory Trial of Esketamine for the Treatment of Rett Syndrome

Clinical trial2025-12-30Completed · ClinicalTrials.gov

Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)

Regulatory2025-10-09FDA

Effect of Intraoperative Esketamine Infusion on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Clinical trial2025-10-01Primary completion · ClinicalTrials.gov

Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial

Clinical trial2025-09-30Primary completion · ClinicalTrials.gov

A Randomised, Controlled Trial to Investigate the Effect of a Sixweek 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.

Clinical trial2025-09-26Results expected Q2 2028 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Esketamine hydrochloride
Aliases & brands
Spravatoesketamine (as hydrochloride)esketamine HCl
RxNorm CUI
2119366
Regulatory jurisdictions
fdaema

Regulatory timeline

19 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2019-03-05 → 2020-07-31)
Earliest approval
2019-03-05
Latest approval
2026-06-24
Authorities
FDA · EMA
Total events
19
fdaU.S. Food and Drug Administration· 18 events
2026-06-24Supplemental approval
Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)
Evidence ↗
2026-04-13Supplemental approval
Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)
Evidence ↗
2026-01-23Supplemental approval
Supplemental approval: ESKETAMINE HYDROCHLORIDE (NDA211243)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-12-18ApprovalMulti-authority
Approval: Spravato (EMA)
Indication: Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different… Show full indication

Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

13 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
13
registered trials across all phases
LATEST COMPLETION 2025
8
Active studies
8
Recruiting
10
Late-stage (III+)
3
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 13
Early Phase 11Phase 11Phase 21Phase 33Phase 45Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Not yet recruitingPH IVChinese PLA General Hospitaln=2762026

Esketamine With or Without Psychedelic Preparation and Integration for Treatment-Resistant Depression: A Randomized Controlled Trial

RecruitingPH IVUniversity of Puerto Ricon=202026

Effects of Esketamine Combined With Propofol for Sedation on Systemic Inflammation and Immune Function in Septic Patients in the ICU: a Single-center, Non-blind, Prospective Randomized Controlled Trial

RecruitingPH IVUnion Hospital, Tongji Medical College, Huazhong University of Science and Technologyn=1002026

Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial

RecruitingPH IVFujian Provincial Hospitaln=1722025

To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery

Unknown statusPH IVZhang XIao Mein=1022025

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Exploratory Trial of Esketamine for the Treatment of Rett Syndrome

CompletedPH IChildren's Hospital of Fudan Universityn=32025

Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging

CompletedN/AMedical University of Viennan=522012

Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

CompletedPH IUniversity Hospital, Basel, Switzerland2009
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.