TABLE 3.
FDA approved hemostats under active clinical trials for different indications.
| Trade name | Approved indication | Investigated indication | Sponsor (collaborator) | NCT number [phase] |
|---|---|---|---|---|
| Balfaxar® | Acquired coagulation factor deficiencies | Acute Major Bleeding (on DOAC therapy with factor Xa inhibitor) | Octapharma a | NCT04867837 [3] |
| Bleeding Cardiac Surgery Patients | Octapharma a | NCT05523297 [3] | ||
| Kcentra® | Acute major bleeding, surgery (acquired CF deficiency) | Traumatic Injury | Oregon Health and Science University | NCT04019015 [2] |
| Traumatic Injury | CSL Behring a | NCT05568888 [3] | ||
| RiaSTAP® | Congenital fibrinogen deficiency | Scoliosis Surgery | Brno University Hospital | NCT05391412 [4] |
| Trauma | Australian & New Zealand Intensive Care Research Centre | NCT05449834 [3] | ||
| Lysteda® | Cyclic heavy menstrual bleeding | Postoperative Blood Loss for hip fracture | Ascension Genesys Hospital | NCT05047133 [2/3] |
| Kovaltry® | Hemophilia A | Hemophilia A (Chinese children, adolescents/adults with severe Hemophilia A) | Bayer a | NCT04565236 [4] |
| Adynovate® | Hemophilia A | Hemophilia A (Chinese Men and Boys) | Takeda a | NCT05707351 [3] |
| Hemophilia A (young children up to 5 years) | Takeda a | NCT02615691 [3] | ||
| Altuviiio® | Hemophilia A | Hemophilia A (previously treated with Altuviiio, newly initiated (in China only), prophylactic regimen ahead of major surgery | Sanofi a | NCT04644575 [3] |
| Roctavian™ | Hemophilia A | Hemophilia A (Receiving Prophylactic Corticosteroids | BioMarin Pharmaceutical a | NCT04323098 [3] |
| Hemophilia A (Receiving Prophylactic FVIII Infusions) | BioMarin Pharmaceutical a | NCT03370913 [3] | ||
| Hemophilia A (with inhibitors to FVIII) | BioMarin Pharmaceutical a | NCT04684940 [1/2] | ||
| Hemophilia A (with pre‐existing antibodies against AAV5) | BioMarin Pharmaceutical a | NCT03520712 [1/2] | ||
| Severe Hemophilia A | BioMarin Pharmaceutical a | NCT02576795 [1/2] | ||
| Nuwiq® | Hemophilia A | Hemophilia A (women/girls undergoing major surgery) | Octapharma a | NCT05936580 [4] |
| Hemophilia A | Severe Hemophilia A (undergoing major surgery while receiving emicizumab prophylaxis) | Octapharma a | NCT05935358 [4] | |
| Hemlibra® | Hemophilia A | Hemophilia A (prophylaxis for patients who received episodic therapy with FVIII or bypassing agents prior to study) | Hoffmann‐La Roche | NCT03315455 [3] |
| Mild Hemophilia A (Males, 5–45 years without inhibitors) | Indiana Hemophilia &Thrombosis Center, (Genentech a ) | NCT04567511 [4] | ||
| Mild or Moderate Hemophilia A (without FVIII inhibitors) | Hoffmann‐La Roche | NCT04158648 [3] | ||
| Severe Hemophilia A (age 0–12 months) | Hoffmann‐La Roche | NCT04431726 [3] | ||
| Von Willebrand Disease, Type 3|Concomitant VWD and Hemophilia | Bleeding and Clotting Disorders Institute Peoria, Illinois (Genentech a ) | NCT05500807 [1] | ||
| Acquired Hemophilia A | University of Washington (Genentech a ) | NCT05345197 [2] | ||
| Esperoct® | Hemophilia A | Severe Hemophilia A (age 0–6 years); previously untreated | Novo Nordisk a | NCT02137850 [3] |
| Jivi® | Hemophilia A (ages 12 and older) | Hemophilia A (ages 7–12) | Bayer a | NCT05147662 [3] |
| Rebinyn® | Hemophilia B | Hemophilia B (previously treated children) | Novo Nordisk a | NCT01467427 [3] |
| Hemophilia B (Chinese patients) | Novo Nordisk a | NCT05365217 [3] | ||
| Hemgenix® | Hemophilia B | Hemophilia B (to further describe safety profile) | CSL Behring a | NCT03569891 [3] |
| Hemophilia B (with detectable pretreatment AAV5 Nabs) | CSL Behring a | NCT06003387 [3] | ||
| Feiba® | Hemophilia A and B | Hemophilia A (with inhibitors on emicizumab) | Children's Hospital Los Angeles (Takeda a ) | NCT04205175 [4] |
| Novoseven® | Hemophilia A and B | Intracerebral Hemorrhage | University of Cincinnati, (Novo Nordisk a ) | NCT03496883 [3] |
| Sevenfact® | Hemophilia A or B | Hemophilia A or B (with inhibitors in the presence or absence of prophylactic therapies) | American Thrombosis and Hemostasis Network | NCT04647227 [4] |
| Wilate® | Hemophilia A, vWD | Severe Bleeding (Given with platelet transfusions) | University Hospital, Basel | NCT04555785 [4] |
| Severe Von Willebrand Disease (age 0–6 years) | Octapharma a | NCT04953884 [3] | ||
| Alphanate® | Hemophilia A, vWD (except type 3) | Von Willebrand Disease (Type 3) | Grifols Biologicals a | NCT00555555 [4] |
| Tisseel™ | Surgery | Eyelid Surgery | University of Calgary | NCT05358977 [2/3] |
| Evarrest® | Surgery (adults) | Surgery (Pediatric Population) | Ethicon a | NCT03255174 [3] |
| Cyklokapron® | Tooth extraction hemorrhage | Gastric Bypass Hemorrhage | Franciscus Gasthuis | NCT05464394 [3] |
| Intracerebral Hemorrhagic Stroke | Christian Medical College, Ludhiana | NCT05836831 [4] | ||
| Open Cardiac Surgery | Population Health Research Institute | NCT03954314 [3] | ||
| Postpartum Hemorrhage | Cairo University | NCT06010368 [3] | ||
| Postpartum Hemorrhage | London School of Hygiene & Tropical Medicine | NCT05562609 [3] | ||
| Postpartum Hemorrhage | George Washington University | NCT03287336 [2] | ||
| Postpartum Hemorrhage | Karolinska Institutet | NCT06025916 [4] | ||
| Sinus Surgery (Nebulized TXA) | Assiut University | NCT04905901 [3] | ||
| Tangential Skin Excision | St. Olavs Hospital | NCT02918201 [2] | ||
| Vonvendi® | vWD (adults) | vWD (Pediatric and adult participants with severe vWD) | Takeda a | NCT03879135 [3] |
| vWD (Children with severe vWD) | Takeda a | NCT05582993 [3] |
Abbreviations: CF, coagulation factor; DOAC, direct oral anti‐coagulant; Nab, neutralizing antibody; TXA, tranexamic acid; vWD, von Willebrand Disease.
a
Company sponsoring/collaborating in the clinical trial is the same company holding the FDA approval for the original approved indication of the drug (as seen in Table 1).