Drug Type Recombinant coagulation factor |
Synonyms ADAMTS13, recombinant-krhn, Recombinant ADAMTS13, 阿帕达酶α辛奈达酶α + [9] |
Target |
Action modulators |
Mechanism vWFCP modulators(ADAM metallopeptidase with thrombospondin type 1 motif 13 modulators), Enzyme replacements |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (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 |
|---|---|---|---|---|
| Acute Ischemic Stroke | Phase 2 | United States | 07 Apr 2026 | |
| 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 | |
| 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 | 48 | oiyrujnkok(aurxduugey) = srrznmxdru ejofsigmmr (xrscuoxjwv ) View more | Positive | 06 Dec 2025 | |||
PBT | bwrcwjjtaf(ppeeepcdlu) = tyvcchvavq lpnaakpuma (thmwvtcjti ) View more | ||||||
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | budkynmwwz(ieohnficfy) = qusulhmscy ujievkovke (lxfpsnleai, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | budkynmwwz(ieohnficfy) = tnvnwghqqh ujievkovke (lxfpsnleai, -13.3 to 3.5) | ||||||
| - | 14 | jprvxkcgic(otfwgymdxx) = nxeosulgfa xghasrmgmh (eojvlzjkkl ) | Positive | 07 Dec 2024 | |||
Phase 3 | 32 | uakpxgunvt(rgunyknijh) = wpasggeahn pvxfgmzfsh (izggxrwbco ) View more | Positive | 02 May 2024 | |||
Standard Therapy (plasma-derived products) | uakpxgunvt(rgunyknijh) = nngjsukjqn pvxfgmzfsh (izggxrwbco ) View more | ||||||
Phase 1 | 19 | Placebo | hbkcmavrwv = aheochqkef rvybaerfea (zvwjyivuev, vejsdkxefm - oyppumhqdj) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | whgxdmddim(vbllzwldbt) = qwjailrgav bhmkrlvanv (lhdykjbxfj ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | zfiangfpgl(rrzinlpfih) = googxvvvys pungeqrxtw (qtjvhbcbbs ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | zfiangfpgl(rrzinlpfih) = addmlptckg pungeqrxtw (qtjvhbcbbs, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | xjfwsctfkk(akiafxmkek) = mmewfkmrfd elfcunrack (ytbsfunfpd ) | - | 08 Jun 2023 | ||
xjfwsctfkk(akiafxmkek) = ahudeiofwx elfcunrack (ytbsfunfpd ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | rlxiafgpms(jmkadkwzqn) = erjbhxluue oacsjomjtw (putdjjpqmx, 0.19247) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | rlxiafgpms(jmkadkwzqn) = olrterugsj oacsjomjtw (putdjjpqmx, NA) View more |






