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Norzyme
Norzyme is a Small molecule drug developed by National Cancer Center, Korea. It is currently in Phase 2 development. Also known as: placebo.
Norzyme is a pancreatic enzyme supplement used in clinical trials for conditions such as pancreatic cancer, pancreaticoduodenectomy, critically ill patients, enteral feeding, and exocrine pancreatic insufficiency. It has been studied in a Phase 2 trial (NCT01587534) as a treatment for unresectable pancreatic cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Norzyme |
|---|---|
| Also known as | placebo |
| Sponsor | National Cancer Center, Korea |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs (PHASE3)
- The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding (NA)
- The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy (PHASE4)
- Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP) (PHASE2)
- Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency (PHASE2, 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:
- Norzyme CI brief — competitive landscape report
- Norzyme updates RSS · CI watch RSS
- National Cancer Center, Korea portfolio CI
Frequently asked questions about Norzyme
What is Norzyme?
Who makes Norzyme?
Is Norzyme also known as anything else?
What development phase is Norzyme in?
Related
- Manufacturer: National Cancer Center, Korea — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing