Drugs / Oxabact OC5
Oxabact OC5
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03938272 | Mar 2019 → Jul 2021 | primary hyperoxaluria | OxThera | Terminated | No outcome recorded |
| Phase 3 | NCT03116685 | Jan 2018 → Apr 2021 | primary hyperoxaluria | OxThera | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-06-29 | OxThera | Regulatory OxThera Receives Rare Pediatric Disease Designation from U.S. FDA for Oxabact Treatment of Primary Hyperoxaluria cision.com ↗
OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Rare Pediatric Disease Designation for Oxabact OC5. |
| 2019-11-07 | OxThera | Results OxThera presents full 24-month data for Oxabact ® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD at Kidney Week 2019 cision.com ↗
The results show that two years of treatment with Oxabact reduced mean plasma oxalate (Pox) by approximately 40% in PH1 patients with ESRD, without intensification in their dialysis regimen. |
All press releases naming this drug 2 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxabact OC5 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03116685 ↗ |
| Known as | Oxalobacter formigenes HC-1 | “Oxabact OC5 - Oxalobacter formigenes HC-1” NCT03116685 ↗ |
| Known as | Oxalobacter formigenes Strain HC-1 | “Oxabact OC5 - Oxalobacter formigenes Strain HC-1” NCT03938272 ↗ |