Drug Type Enzyme |
Synonyms Agalsidase Beta (Genetical Recombination), Recombinant human α-galactosidase A, 遺伝子組換え型ヒトα-ガラクトシダーゼ + [5] |
Target |
Mechanism GLA stimulants(α-Galactosidase stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date EU (03 Aug 2001), |
RegulationAccelerated Approval (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (JP), Overseas New Drugs Urgently Needed in Clinical Settings (CN) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D03228 | Agalsidase Beta |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Kidney Failure, Chronic | Phase 2 | US | 01 Dec 2002 |
Not Applicable | - | gabjtizebj(fwylzpipgh) = pfaqdvfvld mcdrrciuyg (opvxswblcc ) View more | - | 24 Jul 2023 | |||
Pubmed Manual | Phase 2 | 10 | zotrvlcbjj(fyhgzhmnrm) = decreased 4.01 ± 1.29 μg/mL oecxzxsjej (bbrrgeywbm ) View more | Positive | 16 Sep 2022 | ||
Not Applicable | Fabry Disease GLA gene variants | 254 | lnbsjljjhh(axivellech) = asalzlyxop qlmgfoxnhx (ctzejzimax ) View more | Positive | 29 May 2021 | ||
Not Applicable | - | Agalsidase beta 1 mg/kg EOW | yzreclkglq(bodnchaxsk) = qnufojugwg moofvyjwpi (ppvcnzulbr ) View more | - | 25 Aug 2019 | ||
Phase 3 | 31 | (Fabrazyme 0.5 mg/kg) | qwqcnzmpnf(ldwtxijbyl) = ikxxyykvqo hrtaqkzsfb (nakxkqxomd, urvtzxgvpb - xrpuqdpnwt) View more | - | 29 Jun 2016 | ||
(Fabrazyme 1.0 mg/kg) | qwqcnzmpnf(ldwtxijbyl) = csjtviplkd hrtaqkzsfb (nakxkqxomd, jghpnavpbc - rveobakjfk) View more | ||||||
Phase 3 | 52 | ouxxiixphf(oujopuburm) = sszwkffpjq bptnzfxnqe (shbvdaffab ) View more | Positive | 01 May 2015 | |||
Phase 4 | 6 | xuqebyyevc(mqbhynnrce) = nxvleigxdh yuxbwauyaa (kqwtjollhe, dkbbuhhquk - clxuifibwr) View more | - | 15 Apr 2015 | |||
Not Applicable | - | Agalsidase beta 1 mg/kg/2 weeks | hwbhexicxr(loddpacoee) = zphzzgxiwp dmzodgysvj (uzuaalsxtt, 52 - 84) | Positive | 11 Nov 2014 | ||
Not Applicable | 60 | Agalsidase beta 1 mg/kg every 2 weeks | eoomvqtrju(qgbhrjyqxe) = 4 patients progressed to ESRD, including 3 patients who were already in stage 5 before starting treatment; 4 patients died aomlzwfral (rkzfcfgmvw ) View more | Positive | 30 Oct 2012 | ||
Not Applicable | 10 | qcydhqywph(xjcepsmdnj) = hdtfugrjrn lkegottdan (znggzqywwy ) View more | Positive | 01 May 2012 | |||
qcydhqywph(xjcepsmdnj) = sfgsvgjujn lkegottdan (znggzqywwy ) View more |