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Pediasure
Pediasure is a Small molecule drug developed by Nemours Children's Clinic. It is currently in Phase 2 development.
Pediasure is a nutritional supplement used to treat various conditions, including malnutrition, growth disorders, and ADHD, particularly in young children. It is often used in conjunction with nutritional counseling and other interventions, such as growth hormone therapy.
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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 | Pediasure |
|---|---|
| Sponsor | Nemours Children's Clinic |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children (NA)
- Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation (NA)
- Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition (NA)
- Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication (NA)
- Satiation Study With Children Attending a Tertiary Feeding Clinic (NA)
- Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia (NA)
- Compliance With Dietary Recommendations in Children at Risk for Undernutrition (PHASE3)
- Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer (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:
- Pediasure CI brief — competitive landscape report
- Pediasure updates RSS · CI watch RSS
- Nemours Children's Clinic portfolio CI
Frequently asked questions about Pediasure
What is Pediasure?
Who makes Pediasure?
What development phase is Pediasure in?
Related
- Manufacturer: Nemours Children's Clinic — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing