Last reviewed · How we verify
Racecadotril suspension
Racecadotril suspension is a Small molecule drug developed by Bioprojet. It is currently in Phase 1 development. Also known as: Tiorfast®.
Racecadotril is a small molecule inhibitor of the enzyme neprilysin. It has been studied in clinical trials for conditions such as diarrhea in healthy male volunteers and infants.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 suspension |
|---|---|
| Also known as | Tiorfast® |
| Sponsor | Bioprojet |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea (PHASE3)
- Comparing the Efficacy of Anti-secretory Versus Oral Immunoglobulins for Reducing the Episodes of Diarrhea in Children (NA)
- Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules (PHASE1)
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 suspension CI brief — competitive landscape report
- Racecadotril suspension updates RSS · CI watch RSS
- Bioprojet portfolio CI
Frequently asked questions about Racecadotril suspension
What is Racecadotril suspension?
Who makes Racecadotril suspension?
Is Racecadotril suspension also known as anything else?
What development phase is Racecadotril suspension in?
Related
- Manufacturer: Bioprojet — full pipeline
- Also known as: Tiorfast®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing