human fibrin
Trade name: Tisseel
Biologicalapproved
Approved
May 1, 1998
Tachosil is an equine collagen sponge coated with the human plasma-derived coagulation factors fibrinogen and thrombin. It is used during surgery to stop local bleeding on internal organs (hemostasis). Tachosil reacts upon contact with blood, other body fluids or saline to form a clot that glues it to the tissue surface. — Wikipedia
Clinical trial activity
111 trials · 123 clinical orgs · 3 marketing orgs
Phase 1
10
Phase 2
62
Phase 3
45
Phase 4
21
Earliest trial started Mar 1, 2000 (NCT00181974)
Timeline
1990s
- May 1, 1998
Earliest FDA Approval
2000s
2010s
- Apr 5, 2010
Corza Medical GmbH — NDA Secondary Org
- Dec 5, 2012
Johnson and Johnson — NDA Secondary Org
Indications
Approved for
Studied for
- Anastomotic Leak · Phase 4
- Anticoagulants · Phase 4
- Arthropathy, Neurogenic · Phase 3
- Arthroplasty, Replacement, Knee · Phase 3
- Back Pain · Phase 3
- Basal Cell Carcinoma · Phase 2
- Bile · Phase 2
- Blepharoptosis · Phase 2/Phase 3
- Blood Loss, Surgical · Phase 4
- Breast Neoplasms · Phase 4
- Burns · Phase 1/Phase 2
- Carcinoma, Squamous Cell · Phase 4
- Cardiopulmonary Bypass · Phase 3
- Cardiovascular Diseases · Phase 4
- Cerebrospinal Fluid Leak · Phase 4
- Cervical Intraepithelial Neoplasia · Phase 4
- Chronic Periodontitis · Phase 1/Phase 2
- Cleft Palate · Phase 4
- Corneal Ulcer · Phase 1
- Dermatology · Phase 1
- Dura Mater · Phase 2/Phase 3
- Endometrial Neoplasms · Phase 3
- Epithelial Cells · Phase 4
- Esophageal and Gastric Varices · Phase 3
- Eye Diseases, Hereditary · Phase 2/Phase 3
- Face · Phase 3
- Fistula · Phase 1
- Gallstones · Phase 2
- Gastrointestinal Diseases · Phase 2
- General Surgery · Phase 4
- Hematoma · Phase 4
- Hemorrhage · Phase 4
- Hemostasis · Phase 4
- Hernia · Phase 1
- Hernia, Abdominal · Phase 1
- Hernia, Ventral · Phase 1
- Hip Fractures · Phase 3
- Incisional Hernia · Phase 4
- Infections · Phase 2
- Intervertebral Disc Degeneration · Phase 3
- Intestinal Diseases · Phase 2
- Intraabdominal Infections · Phase 1
- Liver Diseases · Phase 4
- Low Back Pain · Phase 2/Phase 3
- Lymphatic Diseases · Phase 3
- Lymphedema · Phase 3
- Lymphocele · Phase 3
- Mammaplasty · Phase 4
- Mastectomy · Phase 3
- Mastectomy, Segmental · Phase 3
- Melanoma · Phase 4
- Meningioma · Phase 4
- Mesothelioma, Malignant · Phase 1/Phase 2
- Neoplasms · Phase 3
- Obesity, Morbid · Phase 3
- Osteoarthritis · Phase 4
- Pathology · Phase 2
- Periodontitis · Phase 4
- Peripheral Vascular Diseases · Phase 3
- Postoperative Complications · Phase 3
- Postoperative Hemorrhage · Phase 2
- Postoperative Pain · Phase 2
- Prostheses and Implants · Phase 4
- Pterygium · Phase 3
- Radiculopathy · Phase 2/Phase 3
- Rectal Fistula · Phase 3
- Rhinoplasty · Phase 2
- Rhytidoplasty · Phase 3
- Rotator Cuff Injuries · Phase 2
- Seroma · Phase 2
- Soft Tissue Injuries · Phase 4
- Spinal Diseases · Phase 3
- Sternotomy · Phase 3
- Tennis Elbow · Phase 2
- Thyroidectomy · Phase 3
- Thyroid Neoplasms · Phase 3
- Tympanic Membrane Perforation · Phase 3
- Urological Manifestations · Phase 3
- Uterine Cervical Neoplasms · Phase 4
- Vascular Malformations · Phase 3
- Vocal Cord Paralysis · Phase 4
- Vulvar Neoplasms · Phase 3
- Wound Healing · Phase 1
- Wounds and Injuries · Phase 3
Mechanism of action
Approval history
- approvedMay 1, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTachoSil ↗
- NCATSAQ4K8I4R6F ↗
- ChEMBLCHEMBL2108390 ↗
- WikipediaFibrin glue ↗
Also known as
- autologous platelet-rich fibrin glue
- fibrin
- fibrin
- fibrin
- fibrin
- fibrin sealant
- fibrin sealant patch
- fs vh s/d 4 s-apr
- human fibrin
- raplixa
- tachosil
- tisseel
- tisseel
- tissucol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05490940 | N/A | Jan 1, 2023 | Baxalta, University of Bern |
| NCT05358977 | Phase 2/Phase 3 (Phase 3) | May 31, 2022 | University of Calgary |
| NCT05831267 | N/A | Feb 1, 2022 | Alexandria University |
| NCT05234658 | Phase 2 | Jan 21, 2022 | Andalusian Network for Design and Translation of Advanced Therapies |
| NCT05264922 | Phase 2 | Jan 10, 2022 | Advent Health |
| NCT04931615 | Phase 4 | Jan 1, 2022 | University of Essex |
| NCT04664738 | Phase 1 | Mar 16, 2021 | Mayo Clinic, Rion LLC |
| NCT04083807 | Phase 3 | Jul 10, 2019 | Baxalta |
| NCT04151017 | N/A | Jun 12, 2019 | Federal University of Health Science of Porto Alegre |
| NCT03792113 | Phase 2/Phase 3 (Phase 3) | May 31, 2019 | KLE Society's Institute of Dental Sciences |
| NCT03733639 | N/A | Jan 1, 2019 | Badalona Hospital Germans Trias i Pujol |
| NCT04621799 | Phase 2/Phase 3 (Phase 3) | Jun 11, 2018 | Pauza, Kevin, MD |
| NCT03255174 | Phase 4 | Mar 20, 2018 | Ethicon |
| NCT03449082 | Phase 2 | Mar 10, 2018 | Korea Health Industry Development Institute, Seoul National University |
| NCT04839276 | Phase 4 | Jan 1, 2018 | University of Indonesia |
| NCT03276975 | Phase 2 | Dec 18, 2017 | Duke University |
| NCT03310060 | Phase 4 | Nov 1, 2017 | Chang Gung University |
| NCT02584153 | Phase 1 | Jul 1, 2017 | University of California, San Francisco |
| NCT03110783 | Phase 3 | Jul 1, 2017 | Ethicon, Fudan University, Guangzhou Bioseal Biotechnology Co., Ltd. |
| NCT02953145 | Phase 4 | Oct 1, 2016 | University of Alberta |
Showing 20 of 111 trials
Page 1 / 6
Organizations
Research & Development (123)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Baxalta | For profit | 21 | 15 | 4 | 2000 |
| Ethicon | For profit | 21 | 18 | 4 | 2005 |
| Omrix Biopharmaceuticals, Inc. | For profit | 5 | 0 | 2 | 2005 |
| Grifols | For profit | 4 | 4 | 1 | 2008 |
| Mallinckrodt | For profit | 4 | 4 | 2 | 2010 |
| Guangzhou Bioseal Biotechnology Co., Ltd. | For profit | 3 | 1 | 2 | 2013 |
| Jinlin University | Academic/Hospital | 3 | 3 | 2 | 2008 |
| National Cancer Institute (NCI) | Government | 3 | 0 | 3 | 2003 |
| University of Barcelona | Academic/Hospital | 3 | 3 | 1 | 2010 |
| Aristotle University of Thessaloniki | Academic/Hospital | 2 | 2 | 1 | 2014 |
| Duke University | Academic/Hospital | 2 | 1 | 2 | 2002 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2000 |
| Shriners Hospitals for Children | Academic/Hospital | 2 | 0 | 2 | 2000 |
| Takeda | For profit | 2 | 2 | 1 | 2010 |
| University of Arizona | Academic/Hospital | 2 | 0 | 2 | 2002 |
| University of California, Irvine | Academic/Hospital | 2 | 0 | 2 | 2002 |
| University of Cincinnati | Academic/Hospital | 2 | 0 | 2 | 2002 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 1 | 2002 |
| University of Vienna | Academic/Hospital | 2 | 0 | 1 | 2001 |
| Advent Health | Academic/Hospital | 1 | 1 | 1 | 2022 |
123 organizations
Page 1 / 7
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Baxter | For profit | NDA2 | Feb 7, 2000 |
| Baxter | For profit | NDA | Feb 7, 2000 |
| Corza Medical GmbH | For profit | NDA2 | Apr 5, 2010 |
| Johnson and Johnson | For profit | NDA2 | Dec 5, 2012 |