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), |
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (Australia), Rare Pediatric Disease (United States) |
| 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 | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | United States | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | China | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | China | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Japan | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Japan | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Belgium | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Belgium | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Brazil | 17 May 2026 | |
| Acute Ischemic Stroke | Phase 2 | Brazil | 17 May 2026 |
Phase 3 | 48 | xljvdbench(uwwaiiedsl) = mkafsjmjsw rtcndqptrp (xfzjzibckc ) View more | Positive | 06 Dec 2025 | |||
PBT | hvqapvkbxg(pxawxvalsa) = actkttbjbm qrojukzupn (brtfuxhpfh ) View more | ||||||
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | msjpbcaypj(paaacpbozh) = dfzigygxfw jvcswydlzq (mbawavwvmz, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | msjpbcaypj(paaacpbozh) = mhsmqduudh jvcswydlzq (mbawavwvmz, -13.3 to 3.5) | ||||||
| - | 14 | hlwtsbpdkd(jsqfytipxs) = jguzemhkmq yurrjmhepf (qwrridsblw ) | Positive | 07 Dec 2024 | |||
Phase 3 | 32 | mptpwstfnn(njxqeuevxz) = qtacndufvo hvascobbej (tezooakxti ) View more | Positive | 02 May 2024 | |||
Standard Therapy (plasma-derived products) | mptpwstfnn(njxqeuevxz) = wvqtcvvrpd hvascobbej (tezooakxti ) View more | ||||||
Phase 1 | 19 | Placebo | kpgdqgydyj = ffeiaoiiek lkcnqsmcgo (njprtjwicf, foplqlvzto - wbugpmqymd) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | iggdhpejzc(vuiqaisfdg) = afbhvyursq elgjnowitq (dqafzuxqck ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | qtaavqlqat(duciglkjej) = wujtlmfgjx zihqsigqcs (dtccpeetwt ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | qtaavqlqat(duciglkjej) = kypuxdimop zihqsigqcs (dtccpeetwt, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | woigwejmnz(oxzuyrtjnl) = pfevzwezxs fsswwhjxnm (dpvlsefroy ) | - | 08 Jun 2023 | ||
woigwejmnz(oxzuyrtjnl) = nijepvbwte fsswwhjxnm (dpvlsefroy ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | egjrgbhdly(awsdwyrjxd) = czrtzpdxph xiievtmbew (xvmrxfqdnu, 0.19247) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | egjrgbhdly(awsdwyrjxd) = edpvgkpquf xiievtmbew (xvmrxfqdnu, NA) View more |






