← Pipeline|Tirasacituzumab

Tirasacituzumab

NDA/BLA
FOR-8447
Source: Trial-derived·Trials: 1
Modality
Gene Editing
MOA
Anti-Aβ
Target
BET
Pathway
PD-1/PD-L1
OCD
Development Pipeline
Preclinical
~Nov 2018
~Feb 2020
Phase 1
~May 2020
~Aug 2021
Phase 2
~Nov 2021
~Feb 2023
Phase 3
~May 2023
~Aug 2024
NDA/BLA
Nov 2024
NDA/BLACurrent
NCT08366114
788 pts·OCD
2024-11TBD·Completed
788 total pts1 indication
Approved
CompletedCurrentUpcoming
Trial Timeline
NDA/BLA
Complet…
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT08366114NDA/BLAOCDCompleted788FEV1
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-5767PfizerPhase 1/2BETCDK4/6i
LLY-8369Eli LillyApprovedMeninAnti-Aβ
RHH-1969RocheApprovedBETCDK4/6i
NVS-5439NovartisPreclinicalBETAnti-Tau
ABB-8696AbbViePhase 3BCMAAnti-Aβ
IvocapivasertibBristol-Myers SquibbPhase 1BETCDK4/6i
BAY-6035BayerPhase 1C5Anti-Aβ
ZenotinibBioNTechPhase 1CGRPAnti-Aβ
AdagracapivasertibBeiGeneNDA/BLABETCDK4/6i
207-5197Samsung BiologicsApprovedBETPD-L1i