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SMOFlipid 20%
SMOFlipid 20% is a Small molecule drug developed by The Hospital for Sick Children. It is currently in Phase 2 development.
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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 | SMOFlipid 20% |
|---|---|
| Sponsor | The Hospital for Sick Children |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Anemia
- Hypoalbuminemia
- Hypochloremia
- Metabolic alkalosis
- Elevated GGT
- Hypophosphatemia
- Hypoglycemia
- Hypertriglyceridemia
- Thrombocytopenia
- Neutropenia
- Hyponatremia
- Thrombosis
Key clinical trials
- Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates (PHASE3)
- Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial) (PHASE3)
- Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care (PHASE3)
- Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age (PHASE4)
- Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants (PHASE3)
- Lipid Emulsion Infusion and COVID-19 Patients (PHASE3)
- Lipid Emulsion in Cardiac Valve Replacement Surgery (NA)
- Effects of Parenteral Nutrition in HSCT (NA)
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:
- SMOFlipid 20% CI brief — competitive landscape report
- SMOFlipid 20% updates RSS · CI watch RSS
- The Hospital for Sick Children portfolio CI
Frequently asked questions about SMOFlipid 20%
What is SMOFlipid 20%?
Who makes SMOFlipid 20%?
What development phase is SMOFlipid 20% in?
What are the side effects of SMOFlipid 20%?
Related
- Manufacturer: The Hospital for Sick Children — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing