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Racecadotril plus ORS
Racecadotril plus ORS is a Enkephalinase inhibitor Small molecule drug developed by Abbott. It is currently in Phase 3 development for Acute diarrhea in children, Infectious diarrhea.
Racecadotril inhibits enkephalinase to reduce intestinal fluid secretion, while ORS provides oral rehydration therapy to replace lost electrolytes and fluids.
Racecadotril is a small molecule neprilysin inhibitor used to treat various forms of diarrhea, including infantile and acute watery diarrhea. It is typically administered in combination with Oral Rehydration Solution (ORS) for treatment.
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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 | Racecadotril plus ORS |
|---|---|
| Sponsor | Abbott |
| Drug class | Enkephalinase inhibitor |
| Target | Enkephalinase (neutral endopeptidase) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Racecadotril is an enkephalinase inhibitor that prevents the breakdown of enkephalins, endogenous opioid peptides that reduce intestinal fluid secretion and chloride transport. When combined with oral rehydration solution (ORS), it addresses both the underlying cause of diarrhea and the symptomatic fluid/electrolyte loss. This combination approach is particularly effective in acute infectious diarrhea, especially in children.
Approved indications
- Acute diarrhea in children
- Infectious diarrhea
Common side effects
- Abdominal pain
- Nausea
- Vomiting
- Headache
Key clinical trials
- Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children (PHASE1, PHASE2)
- Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea (PHASE3)
- Anti-Secretory Drug in Treatment of Acute Watery Diarrhea (PHASE1)
- Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial (NA)
- Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea (PHASE3)
- Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico (PHASE3)
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:
- Racecadotril plus ORS CI brief — competitive landscape report
- Racecadotril plus ORS updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about Racecadotril plus ORS
What is Racecadotril plus ORS?
How does Racecadotril plus ORS work?
What is Racecadotril plus ORS used for?
Who makes Racecadotril plus ORS?
What drug class is Racecadotril plus ORS in?
What development phase is Racecadotril plus ORS in?
What are the side effects of Racecadotril plus ORS?
What does Racecadotril plus ORS target?
Related
- Drug class: All Enkephalinase inhibitor drugs
- Target: All drugs targeting Enkephalinase (neutral endopeptidase)
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Acute diarrhea in children
- Indication: Drugs for Infectious diarrhea
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing