Drugs / TachoSil
TachoSil
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | TachoSil | — | 2004-06-08 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04660721 | May 2021 → May 2023 | vascular hemostatic disease | Sealantium Medical Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00713661 | Jun 2008 → Jun 2009 | — | Nycomed | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06664775 | Apr 2025 → Dec 2026 expected | hemorrhagic disease | Corza Medical GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT01500135 | Mar 2012 → Jun 2015 | hemorrhagic disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01470677 | Nov 2011 → Jan 2016 | cervical cancer, endometrial cancer | Ruhr University of Bochum | Completed | No outcome recorded |
| Phase 3 | NCT00293514 | Feb 2006 → Oct 2007 | lung disorder | Nycomed | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06124209 | Nov 2023 → Dec 2025 | — | Medical University of Warsaw | Unknown | No outcome recorded |
| Phase 4 | NCT03269955 | Feb 2017 → May 2018 | pancreatic neoplasm, periampullary adenocarcinoma | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02629510 | Jan 2015 → Aug 2017 | cervical cancer, cervical intraepithelial neoplasia | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02001857 | Sep 2013 → Feb 2017 | cancer | University Hospital, Ghent | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02105506 | Sep 2012 → Dec 2014 | esophageal disorder, stomach disorder | R. van Hillegersberg | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 33 trials | ||||||
| Phase 3 | NCT02311543 Comparator | Mar 2015 → May 2017 | breast cancer | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT02284256 Comparator | Nov 2014 → Aug 2015 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT01192022 Comparator | Aug 2010 → May 2013 | hemorrhagic disease | Takeda | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03752606 Comparator | Nov 2013 → Dec 2014 | cervical cancer, endometrial cancer, lymphocele | Medical University of Lublin | Completed | No outcome recorded |
| Phase 4 | NCT00918619 Comparator | Jan → Oct 2010 | vascular hemostatic disease | Aesculap AG | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05385952 Comparator | Aug 2022 → May 2024 | liver disorder | GATT Technologies BV | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-02-01 | Takeda | Takeda Completes Sale of TachoSil ® to Corza Health takeda.com ↗ |
| 2020-09-16 | Takeda | Takeda to Divest TachoSil ® to Corza Health for €350 Million takeda.com ↗ |
| 2016-04-27 | Takeda | European Commission Approves Surgical Patch TachoSil ® (human thrombin/human fibrogen) for Use in Neurological Surgery takeda.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TachoSil | “The aim of the study was to evaluate the hemostatic efficacy of the fibrin sealant patch (TachoSil) after loop electrosurgical excision (LEEP) and its influence on other...” PMID 39842025 ↗ Jan 202517“Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy” NCT03269955 ↗ |
| Known as | Fibrin Sealant Patch | “fibrin sealant patch (FSP; TachoSil; Takeda Pharma A/S)” PMID 26776356 ↗ Dec 2015 |
| Known as | FSP | “fibrin sealant patch (FSP; TachoSil; Takeda Pharma A/S)” PMID 26776356 ↗ Dec 2015 |
| Known as | Tachosil fibrin patch | “Drug: Tachosil fibrin patch” NCT01470677 ↗ |
| Known as | Tachosil patch | “Tachosil patch (9.5 x 4.8 cm), containing human fibrinogen (5.5 mg/cm2) and human thrombin (2.0 IU/cm2), applied during surgery.” NCT02105506 ↗ |
| Modality | Other / unclassified | “Sterile, ready-to-use, absorbable sponge for intra-operative topical application.” NCT00713661 ↗ |
| Route | Topical | “intra-operative topical application.” NCT00713661 ↗ |