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IV Ketamine
IV Ketamine is a NMDA receptor antagonist Small molecule drug developed by Icahn School of Medicine at Mount Sinai. It is currently in Phase 3 development for Treatment-resistant depression, Acute suicidal ideation and behavior, Chronic pain conditions. Also known as: ketamine hydrochloride, Ketamine Hydrochloride Injection, Ketamine hydrochloride, No other.
IV ketamine is an NMDA receptor antagonist that blocks glutamate signaling in the brain, producing rapid-onset dissociative and analgesic effects.
IV Ketamine is used in medical settings to study its effects on various conditions, including fractures, intubation complications, and minor surgical procedures. It has been studied in combination with other anesthetics, such as propofol, and as a standalone treatment in clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IV Ketamine |
|---|---|
| Also known as | ketamine hydrochloride, Ketamine Hydrochloride Injection, Ketamine hydrochloride, No other |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Drug class | NMDA receptor antagonist |
| Target | NMDA receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Pain Management |
| Phase | Phase 3 |
Mechanism of action
Ketamine acts as a non-competitive antagonist at the N-methyl-D-aspartate (NMDA) receptor, a major excitatory glutamate receptor in the central nervous system. This mechanism produces dissociation, analgesia, and sedation. In psychiatric applications, particularly for treatment-resistant depression, ketamine's rapid antidepressant effects are thought to involve downstream signaling cascades including mTOR pathway activation and increased synaptic plasticity, distinct from traditional monoamine-based antidepressants.
Approved indications
- Treatment-resistant depression
- Acute suicidal ideation and behavior
- Chronic pain conditions
Common side effects
- Dissociation
- Dizziness
- Nausea
- Increased blood pressure
- Sedation
- Headache
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus (PHASE2)
- Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients (PHASE4)
- Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery (NA)
- The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia (NA)
- Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass (NA)
- InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (PHASE3)
- Prospective IR-led Sedation Feasibility (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IV Ketamine CI brief — competitive landscape report
- IV Ketamine updates RSS · CI watch RSS
- Icahn School of Medicine at Mount Sinai portfolio CI
Frequently asked questions about IV Ketamine
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Related
- Drug class: All NMDA receptor antagonist drugs
- Target: All drugs targeting NMDA receptor
- Manufacturer: Icahn School of Medicine at Mount Sinai — full pipeline
- Therapeutic area: All drugs in Psychiatry / Pain Management
- Indication: Drugs for Treatment-resistant depression
- Indication: Drugs for Acute suicidal ideation and behavior
- Indication: Drugs for Chronic pain conditions
- Also known as: ketamine hydrochloride, Ketamine Hydrochloride Injection, Ketamine hydrochloride, No other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing