Drugs / Collagenase histiolyticum
Collagenase histiolyticum
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed familial Dupuytren contracture 1 milestone | |||||
| Filed | Other | XIAFLEX | familial Dupuytren contracture | 2013-07-16 | “In addition, a XIAFLEX submission has been filed for approval in Australia for the treatment of Dupuytren's contracture.” sobi.com ↗ |
| Filed Peyronie disease 1 milestone | |||||
| Filed | EU (EMA) | Xiapex | Peyronie disease | 2014-06-25 | “Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.” sobi.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 0 | NCT03898661 | Mar 2019 → Jun 2020 | collagenopathy | University Hospital, Ghent | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-06-30 | Sobi, Inc. | Regulatory Xiapex® gets recommendation to be made available on National Health Service in England sobi.com ↗
NICE recommends CCH as an option for treating Dupuytren’s contracture with a palpable cord in adults who are not taking part in an ongoing clinical trial comparing CCH to limited fasciectomy, if all of the following apply: |
| 2015-01-30 | Sobi, Inc. | Regulatory Xiapex approved by the EU Commission for the treatment of Peyronie's disease sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the EU Commission has approved Xiapex® (collagenase clostridium histolyticum) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. |
| 2014-06-25 | Sobi, Inc. | Regulatory Sobi files for EU approval of Xiapex for Peyronies disease sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc.today announced that Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-06-30 | Sobi, Inc. | Xiapex® gets recommendation to be made available on National Health Service in England sobi.com ↗ |
| 2015-01-30 | Sobi, Inc. | Xiapex approved by the EU Commission for the treatment of Peyronie's disease sobi.com ↗ |
| 2014-06-25 | Sobi, Inc. | Sobi files for EU approval of Xiapex for Peyronies disease sobi.com ↗ |
| 2014-04-07 | Sobi, Inc. | Sobi becomes market authorisation holder for Xiapex in Europe sobi.com ↗ |
| 2013-07-16 | Sobi, Inc. | Auxilium Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB (publ) enter a collaboration agreement for XIAPEX® in 71 Eurasian and African countries sobi.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Collagenase histiolyticum | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03898661 ↗ |
| Known as | collagenase clostridium histolyticum | “In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture...” NCT03898661 ↗ |
| Known as | Xiapex | “In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture...” NCT03898661 ↗ |
| Known as | XiapexR | “In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture...” NCT03898661 ↗ |
| Modality | Protein / enzyme biologic | “Xiapex is a mixture of two collagenases, enzymes produced by the bacterium Clostridium histolyticum” NCT03898661 ↗ |
| Route | Other | “Intralaesional injection.” NCT03898661 ↗ |