Drugs / Doripenem
Doripenem
also known as
[14C]-DORIPENEM · Doribax · Doripenem (Doribax) · Doripenem hydrate · DORIPENEM MONOHYDRATE · Dripenem hydrate · Finibax · S-4661
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Doribax | — | 2014-07-31 | europa.eu ↗ |
| Approved | EU (EMA) | Doribax | — | 2008-07-25 | europa.eu ↗ |
| Approved | US (FDA) | DORIBAX | — | 2007-10-12 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01281462 Comparator | Dec 2010 → Mar 2012 | urinary tract infection | Forest Laboratories | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01599806 Comparator | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01595438 Comparator | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01401010 Comparator | Aug 2010 → Feb 2012 | neutropenia | Gary E. Stein, Pharm.D. | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Doripenem | “Doripenem was evaluated in adults with complicated urinary tract infections and pyelonephritis in two phase 3 studies.” PMID 21303745 ↗ Dec 201025 |
| Known as | [14C]-DORIPENEM | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | Doribax | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | Doripenem (Doribax) | “Doripenem (Doribax)” NCT01467648 ↗ |
| Known as | Doripenem hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | DORIPENEM MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | Dripenem hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | Finibax | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Known as | S-4661 | ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗ |
| Modality | Small molecule | “Doripenem is a new carbapenem, recently approved in the US for the treatment of adults with complicated urinary tract infections (cUTI) or complicated intra-abdominal infections (cIAI)” PMID 19670912 ↗ 2009 |
| Route | Intravenous | “intravenous doripenem versus a comparator antibiotic” NCT00210938 ↗ |