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Wafermine
Wafermine is a Small molecule drug developed by iX Biopharma Ltd.. It is currently in Phase 2 development. Also known as: Sublingual ketamine.
Wafermine is a medication available in 50 mg and 75 mg doses, administered as sublingual wafers. It has been studied in clinical trials for conditions such as pain, acute pain, bunion, and post-operative pain following abdominoplasty.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Wafermine |
|---|---|
| Also known as | Sublingual ketamine |
| Sponsor | iX Biopharma Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain (PHASE2)
- Crossover Study to Evaluate the PK Effects of Two Different Wafer Administration Protocols. (PHASE2)
- A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy (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:
- Wafermine CI brief — competitive landscape report
- Wafermine updates RSS · CI watch RSS
- iX Biopharma Ltd. portfolio CI
Frequently asked questions about Wafermine
What is Wafermine?
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What development phase is Wafermine in?
Related
- Manufacturer: iX Biopharma Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Sublingual ketamine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing