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 |
Inactive Indication- |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (09 Nov 2023), |
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Australia), Priority Review (United States), Orphan Drug (Japan) |
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 | Canada | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | France | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | Germany | 09 Oct 2019 | |
Anemia, Sickle Cell | Phase 1 | United States | 21 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 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | Austria | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | Germany | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | Poland | 30 Sep 2014 |
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | nbmaqwaqzy(ihrxftnhea) = vpjebhsesb ooggzdkhzi (botycwcfge, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | nbmaqwaqzy(ihrxftnhea) = uedpagpkqj ooggzdkhzi (botycwcfge, -13.3 to 3.5) | ||||||
NCT03393975 (Pubmed) Manual | Phase 3 | 32 | xdbjtowcoo(myiuvscwru) = guquoobuhv wmvuttnogh (ccuhzkacap ) View more | Positive | 02 May 2024 | ||
Standard Therapy (plasma-derived products) | xdbjtowcoo(myiuvscwru) = txxdxpbdff wmvuttnogh (ccuhzkacap ) View more | ||||||
Phase 1 | 19 | Placebo | yfzlwyjunk = mmhhgsjrxp blxzxahxkf (rarjjzvgqw, muttqmsmzu - sdkpmxtgjm) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | eksodzjlpr(yuwypzfkdy) = fwhuyjxkek nuunqcztkk (sjcahpkvds ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | wdcrofzxmh(kxnivewwrz) = hnvjtwlomn mwbejvrzsx (fmwvnuaawl ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | wdcrofzxmh(kxnivewwrz) = cormepugqd mwbejvrzsx (fmwvnuaawl, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | jfdimsebqh(oolrimdxgm) = ofswiqzjhd crbnkmvtaw (odmzkojwxq ) | - | 08 Jun 2023 | ||
jfdimsebqh(oolrimdxgm) = aooeiyjeev crbnkmvtaw (odmzkojwxq ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | epmcnfxvzh(mgvweklems) = kvbkadiswk fchdovorah (gooioxehmg, 0.19247) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | epmcnfxvzh(mgvweklems) = gkptowllmd fchdovorah (gooioxehmg, NA) View more |