← Pipeline|BBI-9525

BBI-9525

NDA/BLA
Source: Trial-derived·Trials: 2
Modality
Cell Therapy
MOA
CD47i
Target
PLK4
Pathway
Angiogenesis
LGSHNSCCIPF
Development Pipeline
Preclinical
~Jul 2017
~Oct 2018
Phase 1
~Jan 2019
~Apr 2020
Phase 2
~Jul 2020
~Oct 2021
Phase 3
~Jan 2022
~Apr 2023
NDA/BLA
Jul 2023
Aug 2028
NDA/BLACurrent
NCT08032434
2,093 pts·IPF
2023-072028-08·Not yet recruiting
NCT03789699
1,510 pts·LGS
2025-022025-01·Terminated
3,603 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-01-101.2y agoPh3 Readout· LGS
2028-08-282.4y awayPh3 Readout· IPF
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2025-01-10 · 1.2y ago
LGS
Ph3 Readout
2028-08-28 · 2.4y away
IPF
TerminatedNot yet recruiting|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT08032434NDA/BLAIPFNot yet recr...2093EDSS
NCT03789699NDA/BLALGSTerminated1510FEV1
Competitors (10)
DrugCompanyPhaseTargetMOA
NirarelsinJohnson & JohnsonPhase 2PRMT5CD47i
CevizanubrutinibJohnson & JohnsonPreclinicalFcRnCD47i
CeviglumideRocheNDA/BLAB7-H3CD47i
NVS-1475NovartisPhase 2MeninCD47i
AZN-6294AstraZenecaPhase 2/3APOC3CD47i
ZenonesiranGSKPreclinicalDLL3CD47i
AMG-7379AmgenPreclinicalDLL3CD47i
BemanesiranBioNTechPhase 3PLK4HPK1i
BGN-3859BeiGeneApprovedPSMACD47i
ZanurapivirNeurocrineNDA/BLAEGFRCD47i