Drugs / Pylera
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PYLERA | — | 2006-09-28 | fda.gov ↗ |
Trials 1 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00669955 | Jun 2008 → Jul 2009 | Helicobacter pylori infectious disease | Forest Laboratories | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05100446 Comparator | May → Dec 2021 | Helicobacter pylori infectious disease, gastric cancer, gastritis | Unidade Local de Saúde do Alto Ave, EPE | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06200779 Comparator | Sep 2025 → Sep 2026 expected | Helicobacter pylori infectious disease | Manuel Coelho da Rocha | Not yet recruiting | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pylera | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06200779 ↗ |