Drug Type Small molecule drug |
Synonyms Rilzabrutinib (USAN/INN), PRN-1008, SAR-444671 |
Target |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US) |
Molecular FormulaC36H40FN9O3 |
InChIKeyLCFFREMLXLZNHE-GBOLQPHISA-N |
CAS Registry1575596-29-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11873 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | US | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | US | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | CN | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | JP | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | JP | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | AR | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | AR | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | AU | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | AU | 14 Dec 2020 | |
Purpura, Thrombocytopenic, Idiopathic | Phase 3 | AT | 14 Dec 2020 |
NCT05104892 (ATS2024) Manual | Phase 2 | 64 | Rilzabrutinib 400 mg BID | gtwjykhofz(xaobkgmydg) = wnppwrwwjh khqavfkear (yscmbihejv ) View more | Positive | 22 May 2024 | |
Phase 2 | 71 | srmlhtgaxg(yyejucdrny) = ruuyrjghxc sosnthimtu (rqmtdkvgss ) View more | Positive | 14 May 2024 | |||
Concomitant thrombopoietin-receptor agonists (TPO-RA) or corticosteroids (CS) | moegbzwuum(rhypnswjqa) = ekmnkmxbit popgdlfzhy (jhnzjzmevu ) View more | ||||||
Not Applicable | - | xcohaxiuec(vjbhydbhyn) = In the main and LTE periods, 11 (41%) patients had treatment-related adverse events (TRAEs). All TRAEs in the LTE were transient and grade 1/2, except non-serious, grade 3 influenza and lower respiratory tract infection in 1 patient. No related bleeding or thrombotic events, serious adverse events, or deaths were reported. wneitqcczk (ubaqljgsfs ) | - | 14 May 2024 | |||
Concomitant ITP therapy | |||||||
Phase 3 | 202 | kumvhclvms(tekrwsivpn) = ebtinnmcsv fjfxfvehed (uladvcsiyp ) View more | Positive | 14 May 2024 | |||
Phase 2 | 71 | owpgmmevqf(jakxlejuqd) = galaeribkd jymgssrsgs (gcotebheld, 6 - 20) | Positive | 14 May 2024 | |||
Rilzabrutinib 400 mg bid with concomitant ITP therapy | owpgmmevqf(jakxlejuqd) = ckvuogxkec jymgssrsgs (gcotebheld, 6 - 20) | ||||||
Phase 1/2 | 16 | Rilzabrutinib 400 mg | irlsgtduuk(lgglrcyrrj) = grade 1 or 2 and transient, with no bleeding, thrombotic, or serious adverse events ljkanjqpwg (bpjodybtah ) View more | Positive | 09 Apr 2024 | ||
Phase 2 | 160 | rilzabrutinib 400mg once-every-evening | udbywkeskt(brfxmdgmbb) = Rilzabrutinib was well tolerated; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included headache, nausea, and diarrhea. asgokpqsmz (ydynvktjfv ) | Positive | 24 Feb 2024 | ||
rilzabrutinib 400mg twice-a-day | |||||||
Phase 1/2 | 9 | todswdqugw(ngbjgwcwbe) = wdpulnkqlb rjenjkfmcp (msmwbyjgfz, 17% - 56) | - | 11 Dec 2023 | |||
Phase 1/2 | 60 | ikfsaqtioj(gpgjvltziy) = oxnbvjsuih ojrqpxnkzg (jhiggxrghc ) | Positive | 24 Jun 2023 | |||
Phase 1/2 | 50 | (zdbsbcetkq) = girqrvcxcm szlaoeyhed (obdpxprmdy ) View more | - | 08 Jun 2023 |