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ketamine in lactation
ketamine in lactation is a Small molecule drug developed by The Ketamine Research Foundation. It is currently in Phase 1 development. Also known as: Assessing concentration of ketamine in breast milk at intervals.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | ketamine in lactation |
|---|---|
| Also known as | Assessing concentration of ketamine in breast milk at intervals |
| Sponsor | The Ketamine Research Foundation |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparing Nebulized Ketamine,Nebulized Ketamine and Precedex and IM Ketamine for Analgesia in Pediatric Burn (PHASE1)
- IV Ketamine Vs. in Esketamine for MDD TRD
- The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women (EARLY_PHASE1)
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:
- ketamine in lactation CI brief — competitive landscape report
- ketamine in lactation updates RSS · CI watch RSS
- The Ketamine Research Foundation portfolio CI
Frequently asked questions about ketamine in lactation
What is ketamine in lactation?
Who makes ketamine in lactation?
Is ketamine in lactation also known as anything else?
What development phase is ketamine in lactation in?
Related
- Manufacturer: The Ketamine Research Foundation — full pipeline
- Also known as: Assessing concentration of ketamine in breast milk at intervals
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing