TheraRadar
Data updated: May 26, 2026

KETALAR (ketamine hydrochloride)

Trial Activity: Stable 21 active trials
Other Approved 1970-02-19

Ketalar is a general anesthetic used for patients undergoing diagnostic or surgical procedures that do not require skeletal muscle relaxation. It can be used as the only anesthetic agent or as a way to start anesthesia before giving other medications. Additionally, it serves as a supplement to other anesthetic agents during medical procedures.

Source: FDA Label • PH HEALTH
Jump to: Indications Approvals Trials Competitors Safety Patents

How KETALAR Works

This drug works by acting as a non-selective, non-competitive antagonist of the NMDA receptor, which is a type of ionotropic glutamate receptor. Its primary metabolite, norketamine, also demonstrates activity at this same receptor, though with less affinity than the parent drug.

Source: FDA Label

Development Insights

University of Texas Southwestern Medical Center conducting 4 trials (8%)
67 indications explored (Broad Platform)
→ depression (7 trials)
→ major depressive disorder (7 trials)
→ suicide (4 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
56
Years on Market

Details

Status
Prescription
First Approved
1970-02-19
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

PH HEALTH
Active Ingredient: KETAMINE HYDROCHLORIDE

KETALAR Approval History

1971
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Original
New Indication
New Form
Label Update
81 FDA actions from 1970 to 2026 · 1 indication expansions
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Mar 2026 SUPPL
Label · Labeling
Oct 2025 SUPPL
Label · Labeling
FDA Letter Label

What KETALAR Treats

3 indications

KETALAR is approved for 3 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diagnostic and surgical procedures not requiring skeletal muscle relaxation
  • Induction of anesthesia prior to other general anesthetics
  • Supplementation of other anesthetic agents
Source: FDA Label

KETALAR Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

SPRAVATO
Johnson &
2019 2 indic.
METHADONE HYDROCHLORIDE INTENSOL
Hikma
1988 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

TETRACAINE HYDROCHLORIDE
BAUSCH LOMB
2016 1 indic.
TIVICAY
VIIV HLTHCARE
2013 2 indic.
Unlock 9 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

54 trials
Trial Sponsor ID Phase Status Title
NCT07088380 Ketamina PRIN - 20227EA9AN Ph 3 recruiting Ketamine Augmentation of ECT in Treatment-Resistant Depression
NCT07569198 KET-DBT 25-5431 Ph 2 not yet recruiting Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
NCT05962424 70198 Ph 1 recruiting HNC: Human Neural Circuits Electrophysiology During Cognition
NCT05639322 PSYKED-NP P-003 Ph 4 completed Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
NCT06496750 KMD STU-2023-1086 Ph 2 recruiting Ketamine for Methamphetamine Use Disorder
NCT02543983 150188 15-M-0188 Ph 2 recruiting Neurobiology of Suicide
NCT04763343 21-154 1R01MH125214-01 Ph 3 recruiting Ketamine Treatment of Youth Suicide Attempters
NCT06402955 2000037090 R01NS125482-01A1 Ph 2 recruiting Imaging Depression in Parkinson's Disease
NCT05437575 PAIN STUDY22010164 HT9425-25-F-0041 Ph 3 recruiting Prehospital Analgesia INtervention Trial (PAIN)
NCT05339074 KET-BD-Sustain 21-5963 Ph 2 completed Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression
NCT05004896 KET-BD 21-5560 Ph 2 completed Ketamine for Treatment-Resistant Bipolar Disorder
NCT04589208 8063 R01MH123142-01A1 Ph 1, Ph 2 suspended Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)
NCT06835504 MoKA AAAV7115 U01HD116253, IRB00181652 Ph 3 not yet recruiting Morphine or Ketamine for Analgesia
NCT05603104 INTENSIFY 2022-502185-24-00 (EU CT #) Ph 3 recruiting Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT06419439 NURP-001-23F IK2CX002646-01A2 Ph 2 recruiting Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
NCT06480500 Ket-CBT 21-6000 Ph 2 recruiting i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
NCT04592809 TASK STU-2020-0973 R01MH125181 Ph 3 completed Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
NCT05378555 IRB-P00038432 Ph 3 recruiting Oral Ketamine for Treatment of Vaso-Occlusive Pain
NCT05973851 INTENSIFY MDD 2023-506617-21-00 (EU CT#) Ph 3 recruiting 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.
NCT06767358 KANINE 202405KTMN Ph 3 not yet recruiting Ketamine Sedation in the ICU (KANINE) RCT
NCT02967640 2012/1199 2012-002782-35 Ph 2, Ph 3 completed Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
NCT05019885 STUDY-20-01911 Ph 2 recruiting The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
NCT05803551 22-004767 Ph 2 recruiting A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients
NCT07034911 FMASU MS130/2024 Ph 1 completed Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery
NCT04260607 results posted NMCCL.2018.0011 Ph 3 terminated Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
NCT05046184 UNIKET STU-2021-0667 Ph 2 completed Elucidating the Neurocircuitry of Irritability With High-Field Neuroimaging to Identify Novel Therapeutic Targets
NCT06891300 REB 0216 ECR-1-119-23 Ph 2, Ph 3 recruiting Understanding and Treating Suicidal Ideation With Ketamine
NCT05696691 HSC20220426H UL1TR002645 Ph 2, Ph 3 recruiting Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
NCT06090422 KeDA 2022/484848(REK) 2023-506052-24, U1111-1293-2654 Ph 1, Ph 2 not yet recruiting Ketamine for Combined Depression and Alcohol Use Disorder
NCT05855798 esp01 Ph 4 completed Ketamine and Magnesium in Erector Spinae Plane Block
NCT04177706 results posted 00091292 K12DA031794 Ph 2 completed Ketamine for the Treatment of Opioid Use Disorder and Depression
NCT05552391 N-88-2022 Ph 4 completed Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control
NCT05026203 109/2564(IRB1) Ph 4 completed Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
NCT06036511 CONCHKAP 23-116 Ph 1, Ph 2 withdrawn Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
NCT05051449 HP-00096377 Ph 1 terminated Ketamine for OUD and Comorbid Depression (OUDCD)
NCT05565664 MD-60-2022 Ph 4 completed Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy
NCT05032118 PENDULUM 00022844 Ph 2, Ph 3 withdrawn Pilot Study of Ketamine Sedation for Aneurysmal Subarachnoid Hemorrhage
NCT05313659 postoperative agitation Ph 2 completed Intramuscular Ketamine Effect on Postnasal Surgery Agitation
NCT02866071 McMullan Ketamine Ph 3 active not recruiting Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
NCT05451095 1411-0003 Ph 1 withdrawn A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine
NCT03410446 INKeD-PC 16-5754 Ph 2 completed Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
NCT03156504 Bio-K results posted 16-009737 Ph 4 completed The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
NCT03621085 results posted STU 092017-068 Ph 4 completed Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
NCT04216888 KetBiomarkers Ph 2, Ph 3 completed Biomarkers of Response to Ketamine in Depression: MRI and Blood Assays Before and After Open Label Intranasal Ketamine
NCT03375671 RACKED H17-00571 Ph 2 completed Rapid Agitation Control With Ketamine in the Emergency Department
NCT03525821 KETAPED 17-HPNCL-01 Ph 3 completed Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED)
NCT04490031 Hukm Ph 4 recruiting Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
NCT03290625 PV0939-2017 Ph 4 completed Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
NCT03051945 00087544 Ph 3 withdrawn Endogenous Opioid Modulation by Ketamine
NCT02925858 results posted 16-289 Ph 4 completed Effect of Ketamine on Analgesia Post-Cardiac Surgery

Showing 50 of 54 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KETALAR FDA Label Details

Indications & Usage

FDA Label (PDF)

KETALAR is indicated for the treatment of Diagnostic and surgical procedures not requiring skeletal muscle relaxation; Induction of anesthesia prior to other general anesthetics; Supplementation of other anesthetic agents.

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Data Sources

FDA Approval: NDA016812 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment