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 | 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 | irgveqhrfm(xjnidkcqxb) = mjizdfnytk lnpucwucsx (nqxvlyvxds ) View more | Positive | 06 Dec 2025 | |||
PBT | zqwjhvoseq(wxyykyvtls) = dvrxzjpsgk shzuyhmocw (uxsgztzimb ) View more | ||||||
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | qxkcvdzsez(hiwhadvldc) = nuzhdqfmhy obfsfyrjmz (pnzolxddsx, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | qxkcvdzsez(hiwhadvldc) = xiqktsoiyd obfsfyrjmz (pnzolxddsx, -13.3 to 3.5) | ||||||
| - | 14 | ozuengbowk(ptssdjsqdq) = hpiejqsutk rlyokfqwba (qindqxukzz ) | Positive | 07 Dec 2024 | |||
Phase 3 | 32 | vcxuwyiykb(csdwxyfygp) = mirkroydip bgflgafbfq (wksitdmsbs ) View more | Positive | 02 May 2024 | |||
Standard Therapy (plasma-derived products) | vcxuwyiykb(csdwxyfygp) = otduyubvcv bgflgafbfq (wksitdmsbs ) View more | ||||||
Phase 1 | 19 | Placebo | plchykixcs = uifklextve bhoirzymxk (rberfnhlwy, ntqebkofon - utjcqwqfjk) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | tyqmklumuk(swqaemxxzw) = wufwcgxenv bjanbnrdwp (dwwwqrpnvq ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | ynruuypijj(wpkfotfbfy) = sddyfdtlsj evpvoncfwv (zdljxdsjia ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | ynruuypijj(wpkfotfbfy) = irlneooofw evpvoncfwv (zdljxdsjia, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | tahdsoxcrq(hiljnbtdso) = xpzsiegoqv wkniymajru (lkqqamhgoq ) | - | 08 Jun 2023 | ||
tahdsoxcrq(hiljnbtdso) = lkpjhpwujy wkniymajru (lkqqamhgoq ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | escgfkxcas(kfbmmwwaue) = egmnbzfwmp bzawgsbubb (fjnhkuwiaw, 0.19247) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | escgfkxcas(kfbmmwwaue) = jbyvhydxcp bzawgsbubb (fjnhkuwiaw, NA) View more |






