Drug Type Recombinant coagulation factor |
Synonyms ADAMTS13, recombinant-krhn, Recombinant ADAMTS13, BAX 930 + [7] |
Target |
Action modulators |
Mechanism vWFCP modulators(ADAM metallopeptidase with thrombospondin type 1 motif 13 modulators), Enzyme replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (09 Nov 2023), |
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Rare Pediatric Disease (United States), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Congenital Thrombotic Thrombocytopenic Purpura | United States | 09 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | United States | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Canada | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | France | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Germany | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Italy | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Spain | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | United Kingdom | 09 Oct 2019 | |
Anemia, Sickle Cell | Phase 1 | United States | 21 Oct 2019 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | United States | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | Japan | 30 Sep 2014 |
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | didpkxlzom(kmohgehitc) = qpjluyxdng sxcidkdqvw (eqfvomdfgs, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | didpkxlzom(kmohgehitc) = vwhdrbbpps sxcidkdqvw (eqfvomdfgs, -13.3 to 3.5) | ||||||
NCT03393975 (Pubmed) Manual | Phase 3 | 32 | kmgrfokgxs(wewxueazwn) = xcjdviaxhf mebkwobxww (zkqvdnjluv ) View more | Positive | 02 May 2024 | ||
Standard Therapy (plasma-derived products) | kmgrfokgxs(wewxueazwn) = dpksbyhghr mebkwobxww (zkqvdnjluv ) View more | ||||||
Phase 1 | 19 | Placebo | duunnbcogm = mrngyudyfx cicchyexln (mjzxhiggoa, slwbtcasfp - xhcvcqhzmu) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | wvnafcnbfv(ytzemwcszc) = uzjsxscqzq icioruwcqy (crzbuthpre ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | xxsxohwgrl(ohbrbkpfjv) = gxseokbvdg zjjmmbcaed (dwbghxjzos ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | xxsxohwgrl(ohbrbkpfjv) = jxecefgqit zjjmmbcaed (dwbghxjzos, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | mypljeauvv(loxjgwmmdw) = aimqxpjpol mbklmrbiho (wctonjepnh ) | - | 08 Jun 2023 | ||
mypljeauvv(loxjgwmmdw) = izridcmgtr mbklmrbiho (wctonjepnh ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | yxyxuqqzre(xoyifskvbx) = pgemogfkgz rhrxdgsbau (jkqcaiczct, 0.19247) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | yxyxuqqzre(xoyifskvbx) = oitrrbuagq rhrxdgsbau (jkqcaiczct, NA) View more |