CDEK
← All drugs Report issue

esketamine

Trade name: spravato

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Mar 5, 2019

Esketamine is an S(+)-enantiomer of ketamine. It is a nonselective, noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptor. A nasal spray, containing esketamine, was approved in 2019 for the treatment of treatment-resistant depression in adults, in conjunction with an oral antidepressant, and is marketed under tradename SPARAVATO. Esketamine is a schedule III drug product in the USA. — NCATS

Clinical trial activity

246 trials · 111 clinical orgs · 2 marketing orgs

Phase 1
45
Phase 2
46
Phase 3
26
Phase 4
69

Earliest trial started Feb 1, 2009 (NCT00847418)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

  2. Mar 5, 2019

    Janssen Pharmaceutica NV — Earliest FDA Approval

  3. Mar 5, 2019

    Johnson and Johnson — NDA Secondary Org

  4. Mar 5, 2019

    Janssen Pharmaceutica NV — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughMar 5, 2019

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@]1(c2ccccc2Cl)CCCCC1=O
Mol. weight
237.73 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • am-101
  • am-101
  • am-101
  • esketamine
  • esketamine
  • esketamine
  • esketamine
  • esketamine
  • esketamine
  • esketamine hcl
  • esketamine hcl
  • esketamine hcl
  • esketamine hcl
  • esketamine hydrochloride
  • esketamine hydrochloride
  • esketamine hydrochloride
  • programmed cell death 5 protein, rat
  • (s)-(+)-ketamine hydrochloride
  • (s)-(+)-ketamine hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07120477Phase 4Jan 31, 2026University of Sao Paulo
NCT07308756Phase 4Dec 31, 2025Peking University
NCT07063108Phase 4Dec 1, 2025People's Liberation Army of China
NCT07247968Early Phase 1 (Phase 1)Nov 30, 2025Chongqing Medical University
NCT07227454Phase 3Nov 20, 2025—
NCT07151716Phase 4Oct 21, 2025Peking University
NCT07230171N/ASep 15, 2025Capital Medical University
NCT07179913Phase 4Sep 10, 2025Jinlin University
NCT07145775Phase 4Aug 31, 2025Peking University
NCT07062601N/AJul 10, 2025Anqing Municipal Hospital
NCT06853041Phase 4Jun 30, 2025University of Nice Sophia Antipolis
NCT07034950Phase 1/Phase 2 (Phase 2)Jun 29, 2025Xiamen University
NCT07034963Phase 1/Phase 2 (Phase 2)Jun 26, 2025Xiamen University
NCT06795659Phase 1/Phase 2 (Phase 2)Jun 9, 2025University of Texas, San Antonio
NCT07053345Phase 4Jun 9, 2025Janssen Pharmaceutica NV
NCT07002723N/AJun 1, 2025Peking University
NCT06958393Phase 4May 20, 2025Shandong Province Qianfoshan Hospital
NCT07131033Phase 1/Phase 2 (Phase 2)May 6, 2025The Second People's Hospital of Huai'an
NCT07125573N/AMay 1, 2025Kunming Medical University
NCT06900205N/AApr 1, 2025Jiao Tong University
Showing 20 of 246 trials
Page 1 / 13

Organizations

Research & Development (111)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit383752012
Capital Medical UniversityAcademic/Hospital262242020
Peking UniversityAcademic/Hospital262432020
Nanjing Medical UniversityAcademic/Hospital10822020
Tianjin Medical UniversityAcademic/Hospital8712020
Zhejiang UniversityAcademic/Hospital8832020
Chongqing Medical UniversityAcademic/Hospital7722021
Fudan UniversityAcademic/Hospital7532020
Huazhong University of Science and TechnologyAcademic/Hospital7622021
Auris MedicalFor profit6622009
People's Liberation Army of ChinaGovernment6632021
Yangzhou UniversityAcademic/Hospital6612021
Beijing Fangshan District Liangxiang HospitalAcademic/Hospital5012025
Hengshui People's HospitalAcademic/Hospital5012025
Janssen Pharmaceutica NVFor profit5432016
Anhui Medical UniversityAcademic/Hospital4222021
Anqing Municipal HospitalAcademic/Hospital4412022
Jiao Tong UniversityAcademic/Hospital4222021
Maternal and Child Health Hospital of Hubei ProvinceAcademic/Hospital4322021
Southern Medical UniversityAcademic/Hospital4232021
111 organizations
Page 1 / 6

Marketing (2)

OrganizationOrg typeRelationshipDate
Janssen Pharmaceutica NVFor profitNDAMar 5, 2019
Johnson and JohnsonFor profitNDA2Mar 5, 2019