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Pedialyte
Pedialyte is a Small molecule drug developed by The Hospital for Sick Children. It is currently in Phase 3 development.
Pedialyte is an oral electrolyte solution manufactured by Abbott Laboratories, first issued to hospitals in 1966 and later made available for consumer purchase in 1969. It is used to manage conditions such as diarrhea, gastroenteritis, and postoperative feeding following pyloromyotomy, among others, often in conjunction with oral rehydration therapy supplemented with zinc.
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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).
| 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 | Pedialyte |
|---|---|
| Sponsor | The Hospital for Sick Children |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Facilitated Release of Endogenous Enterokines (NA)
- Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status (NA)
- Palatability of Oral Rehydration Solutions (PHASE3)
- "Beverage Hydration Index" of Commercial Therapeutic Beverages (NA)
- A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy (NA)
- Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute (PHASE3)
- Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial (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:
- Pedialyte CI brief — competitive landscape report
- Pedialyte updates RSS · CI watch RSS
- The Hospital for Sick Children portfolio CI
Frequently asked questions about Pedialyte
What is Pedialyte?
Who makes Pedialyte?
What development phase is Pedialyte in?
Related
- Manufacturer: The Hospital for Sick Children — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing