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Espumisan
Espumisan is a Small molecule drug developed by Johnson & Johnson Consumer and Personal Products Worldwide. It is currently in Phase 3 development.
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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). -
Big-pharma sponsor
+3.0pp
Johnson & Johnson Consumer and Personal Products Worldwide is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Espumisan |
|---|---|
| Sponsor | Johnson & Johnson Consumer and Personal Products Worldwide |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- Headache
- Nausea
- Asthenia
Key clinical trials
- Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders (PHASE3)
- Effects of Vivatlac Baby on Crying Behavior of Colicky Babies (PHASE2)
- Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies (NA)
- Use of Mucolytic Solution Before Upper Endoscopy (NA)
- A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers (PHASE1)
- Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia (PHASE3)
- Mucolytic Solution Before Upper Endoscopy (NA)
- Gastric Preparation of Magnetic-controlled Capsule Endoscopy (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:
- Espumisan CI brief — competitive landscape report
- Espumisan updates RSS · CI watch RSS
- Johnson & Johnson Consumer and Personal Products Worldwide portfolio CI
Frequently asked questions about Espumisan
What is Espumisan?
Who makes Espumisan?
What development phase is Espumisan in?
What are the side effects of Espumisan?
Related
- Manufacturer: Johnson & Johnson Consumer and Personal Products Worldwide — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing