KETAMINE HYDROCHLORIDE
Ketamine hydrochloride is used as a general anesthetic for patients undergoing various diagnostic and surgical procedures. It serves as a primary anesthetic agent when skeletal muscle relaxation is not required for the operation. Additionally, clinicians use it to help patients transition into anesthesia before administering other medications or as a supplemental agent during a procedure.
How KETAMINE HYDROCHLORIDE Works
This medication works by acting as a non-selective and non-competitive antagonist at the NMDA receptor, which is a type of glutamate receptor. By binding to these receptors, it blocks the normal activity of glutamate in the central nervous system. Its primary metabolite, norketamine, also contributes to this effect by targeting the same receptors, though with less potency than the original drug.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-03-22
- Routes
- INJECTION, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
KETAMINE HYDROCHLORIDE Approval History
What KETAMINE HYDROCHLORIDE Treats
4 indicationsKETAMINE HYDROCHLORIDE is approved for 4 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diagnostic procedures (not requiring muscle relaxation)
- Surgical procedures (not requiring muscle relaxation)
- Induction of anesthesia
- Supplement to other anesthetic agents
KETAMINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
434 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07088380 Ketamina | PRIN - 20227EA9AN | Ph 3 | recruiting | Ketamine Augmentation of ECT in Treatment-Resistant Depression |
| NCT07182032 | STUDY20250700 | Ph 4 | withdrawn | Ketamine in Central Sensitization |
| NCT01892189 results posted | TAK-063_102 U1111-1141-2177 | Ph 1 | completed | Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults |
| NCT06853041 ESKAPE | 24-PP-09 | Ph 4 | completed | ESKetamine Low-dose vs Ketamine Low-dose for Severe Acute Pain in Emergency Units, Comparison of PsychodyslEptic Effects |
| NCT06490731 | New valley anesthesia 4 | Ph 1, Ph 2 | recruiting | Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients |
| 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) |
| NCT05915013 | 2000021345_a 1R01MH129371-01A1 | Ph 1 | recruiting | Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response |
| NCT05786066 | 2000033608 | Ph 2 | recruiting | The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects |
| NCT02122562 | 201906726 14-M-0085, 4R00AA024142-02 | Ph 2 | recruiting | Ketamine Alcohol (in Treatment-Resistant Depression) |
| NCT07536633 | 2022/926 | Ph 4 | completed | Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery |
| NCT03065335 | 170060 17-M-0060 | Ph 1 | recruiting | Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder |
| NCT05940324 MKET2 | 70954 1R01MH133553-01 | Ph 2 | recruiting | Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2) |
| NCT05962424 | 70198 | Ph 1 | recruiting | HNC: Human Neural Circuits Electrophysiology During Cognition |
| NCT04861051 | 60085 | Ph 1 | recruiting | Understanding Ketamine's Dissociative Effects (KD Study) |
| NCT06085937 | STUDY00150830 | Ph 1 | recruiting | Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department |
| NCT06538285 KARE | H24SB7788 2KL2TR001870 | Ph 2 | active not recruiting | Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV |
| NCT05401227 | 8299 | Ph 1 | suspended | Glutamatergic Mechanisms: Aim2 |
| NCT06231563 KPD | MHBC-004-23S 23-40158, CX002606 | Ph 2 | recruiting | Ketamine for Veterans With Parkinson's Disease |
| NCT05518877 results posted | 22194 | Ph 4 | completed | Low Dose Ketamine Infusion for Analgesia in the Emergency Department to Reduce Side Effects |
| NCT05639322 PSYKED-NP | P-003 | Ph 4 | completed | Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial |
| NCT06868589 RELIEF-LT | 20243140 | Ph 4 | active not recruiting | Reducing Pain With Methadone and Ketamine in Liver Transplant |
| NCT06496750 KMD | STU-2023-1086 | Ph 2 | recruiting | Ketamine for Methamphetamine Use Disorder |
| NCT04248205 | 11475 | Ph 4 | recruiting | Ketamine for Post-operative Analgesia in Hemorrhoidectomy |
| NCT04751175 KETASONA | EudraCT number 2012-002518-38 | Ph 4 | completed | Management of Pain in Lumbar Arthrodesis |
| NCT02543983 | 150188 15-M-0188 | Ph 2 | recruiting | Neurobiology of Suicide |
| NCT06867068 | 2014-3556 | Ph 1 | completed | Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery |
| NCT05277896 RSI results posted | 210500 K23HL153584, BPS-2022C3-30021 | Ph 4 | completed | Randomized Trial of Sedative Choice for Intubation |
| NCT06903819 | IRB-FY2025-75 | Ph 4 | recruiting | Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients |
| NCT06480201 | H-54099 | Ph 1 | suspended | Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression |
| NCT05378100 INKLING-MS | IRB00322473 | Ph 2 | active not recruiting | Ketamine for Multiple Sclerosis Fatigue |
| NCT04763343 | 21-154 1R01MH125214-01 | Ph 3 | recruiting | Ketamine Treatment of Youth Suicide Attempters |
| NCT06781697 TREASURE | 6159 | Ph 3 | not yet recruiting | InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression |
| 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) |
| NCT07443254 | 26-1377 | Ph 1, Ph 2 | recruiting | Prospective IR-led Sedation Feasibility |
| NCT05597878 | IRB00091354 WFBCCC 01122 | Ph 2, Ph 3 | suspended | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy |
| 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 |
| NCT06772753 | IRB00376501 | Ph 1 | recruiting | Investigation of Psychedelic Effects in Psychoactive Substances |
| NCT05233566 K-PASS results posted | 202201107 | Ph 3 | completed | Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial |
| NCT05306899 KetHead | 21-5523 | Ph 3 | recruiting | Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches |
| NCT04275661 | ESPB in breast cancer surgery | Ph 2 | completed | Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery |
| NCT07369089 | 177164 | Ph 2 | not yet recruiting | Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement |
| NCT04589208 | 8063 R01MH123142-01A1 | Ph 1, Ph 2 | suspended | Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1) |
| NCT07370181 Ketamine | 04-2025-300750 | Ph 3 | not yet recruiting | Ketamine Irrigation Analgesia in Laparoscopic Cholecystectomy |
| NCT06835504 MoKA | AAAV7115 U01HD116253, IRB00181652 | Ph 3 | not yet recruiting | Morphine or Ketamine for Analgesia |
| NCT04781673 | 2019-508 | Ph 4 | active not recruiting | Ketamine vs Lidocaine in Traumatic Rib Fractures |
| 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 |
| NCT07330375 | 1088 | Ph 3 | not yet recruiting | Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia |
| NCT06060210 | RC 12-9-2023 | Ph 4 | completed | Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion |
Showing 50 of 434 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
KETAMINE HYDROCHLORIDE FDA Label Details
Indications & Usage
KETAMINE HYDROCHLORIDE is indicated for the treatment of Diagnostic procedures (not requiring muscle relaxation); Surgical procedures (not requiring muscle relaxation); Induction of anesthesia; Supplement to other anesthetic agents.
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KETALAR
Full clinical data, patents, trials, and competitive landscape for ketamine hydrochloride.
Data Sources
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