Drug Type Recombinant coagulation factor |
Synonyms ADAMTS13, recombinant-krhn, Recombinant ADAMTS13, BAX 930 + [7] |
Target |
Mechanism vWFCP modulators(ADAM metallopeptidase with thrombospondin type 1 motif 13 modulators), Enzyme replacements |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (09 Nov 2023), |
RegulationPriority Review (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (AU), Rare Pediatric Disease (US), Orphan Drug (JP) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Congenital Thrombotic Thrombocytopenic Purpura | US | 09 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | CA | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | FR | 09 Oct 2019 | |
Thrombotic Thrombocytopenic Purpura, Acquired | Phase 2 | DE | 09 Oct 2019 | |
Anemia, Sickle Cell | Phase 1 | US | 21 Oct 2019 | |
Anemia, Sickle Cell | Phase 1 | US | 21 Oct 2019 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | US | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | JP | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | AT | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | DE | 30 Sep 2014 | |
Purpura, Thrombotic Thrombocytopenic | Phase 1 | PL | 30 Sep 2014 |
Phase 3 | Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme | VWF total protein antigen | VWF activity | 36 | epomkttxbd(jsgbwsmcoe) = aephiqavjr uidtqbptgc (segftzqvtq, -29.5 to to 2.4) | Positive | 09 Dec 2024 | ||
Plasma-based therapies (PBT) | epomkttxbd(jsgbwsmcoe) = szdutunksl uidtqbptgc (segftzqvtq, -13.3 to 3.5) | ||||||
NCT03393975 (Pubmed) Manual | Phase 3 | 32 | ofprifggkn(oiqiliwjju) = rlqbspzpbl dndxgnrguh (xerfjknkty ) View more | Positive | 02 May 2024 | ||
Standard Therapy (plasma-derived products) | ofprifggkn(oiqiliwjju) = xannbjbwpz dndxgnrguh (xerfjknkty ) View more | ||||||
Phase 1 | 19 | Placebo | vfstvpnnjm(wazmmsmocg) = wnoojtoqic eczcrbmubs (vncmhghsgg, lsbvtogato - ramaxzpmfd) View more | - | 23 Apr 2024 | ||
Phase 1 | 19 | tgybygctbd(yaajvjvvps) = gqvbnkobst vhanmetkjo (aehekuvkvs ) View more | Positive | 09 Dec 2023 | |||
FDA Manual | Not Applicable | 86 | uobsshcrml(pwrfcmwspk) = zlfllijabx uapccixkxv (focxnzduxg ) View more | Positive | 09 Nov 2023 | ||
Plasma-Based Therapies | uobsshcrml(pwrfcmwspk) = crmxrusqpy uapccixkxv (focxnzduxg, 0.304) View more | ||||||
Phase 2 | 28 | Placebo | bpnrdmzuwg(wnjuqtpvgx) = rpcokhnlri umkshpvipx (tnfebnhshk ) | - | 08 Jun 2023 | ||
bpnrdmzuwg(wnjuqtpvgx) = splrkfgpbx umkshpvipx (tnfebnhshk ) | |||||||
Phase 2 | 28 | Placebo (Standard of Care (SoC) + Placebo) | yywotawvuj(qzkohxiucy) = lmzvpiysyi wbhwovozlt (yqeaijectc, xkmatlubaj - pdedalsxxr) View more | - | 01 Dec 2022 | ||
Placebo+SHP655 (SoC + SHP655 + Placebo) | yywotawvuj(qzkohxiucy) = oedexuglkp wbhwovozlt (yqeaijectc, knzdthdayo - erlgxcgotv) View more |