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Duphalac
Duphalac is a Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 3 development. Also known as: Laxative.
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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 | Duphalac |
|---|---|
| Also known as | Laxative |
| Sponsor | National Taiwan University Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) (NA)
- Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
- Evaluation of the Outcome of Fecal Microbiota Transplantation (PHASE1, PHASE2)
- Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy (PHASE1, PHASE2)
- LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study
- Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. (NA)
- Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (PHASE4)
- New Mechanisms of Obesity (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:
- Duphalac CI brief — competitive landscape report
- Duphalac updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI
Frequently asked questions about Duphalac
What is Duphalac?
Who makes Duphalac?
Is Duphalac also known as anything else?
What development phase is Duphalac in?
Related
- Manufacturer: National Taiwan University Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Laxative
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing