Drugs / Lipase
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COTAZYM | — | 1996-12-09 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT07441824 | Apr 2026 → Jun 2027 expected | acute necrotizing pancreatitis, exocrine pancreatic insufficiency | Asian Institute of Gastroenterology, India | Recruiting | No outcome recorded |
| Phase 3 | NCT07211568 | Oct 2025 → Apr 2027 expected | acute necrotizing pancreatitis | Asian Institute of Gastroenterology, India | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT03247101 Comparator | Feb 2016 → Dec 2017 | gallstones | Min-Sheng General Hospital | Unknown | Met primary |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lipase | “Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m” NCT07441824 ↗2“Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U.” NCT07211568 ↗ “Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months” NCT03247101 ↗ |
| Action | Restore | “pancreatic enzyme replacement therapy” NCT07211568 ↗ |
| Modality | Protein / enzyme biologic | “enzyme preparation” NCT07211568 ↗ |
| Route | Oral | “Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months” NCT03247101 ↗ |