← Pipeline|FRE-IIT-984

FRE-IIT-984

Approved
Source: Trial-derived·Trials: 1
Modality
siRNA
MOA
CDK2i
Target
EGFR
Pathway
Ferroptosis
Breast Ca
Development Pipeline
Preclinical
~Aug 2014
~Nov 2015
Phase 1
~Feb 2016
~May 2017
Phase 2
~Aug 2017
~Nov 2018
Phase 3
~Feb 2019
~May 2020
NDA/BLA
~Aug 2020
~Nov 2021
Approved
Feb 2022
Mar 2026
ApprovedCurrent
NCT03672672
550 pts·Breast Ca
2022-022026-03·Active
550 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-03-231w agoPh3 Readout· Breast Ca
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2
Approved
Active
Catalysts
Ph3 Readout
2026-03-23 · 1w ago
Breast Ca
Active|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03672672ApprovedBreast CaActive550UPDRS
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-3703PfizerPhase 1/2CDK2CDK2i
TirafotisoranRochePhase 2CD38CDK2i
ABB-3951AbbViePhase 2/3TNFαCDK2i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
TAK-1836TakedaPreclinicalEGFRKIF18Ai
TirasotorasibTakedaNDA/BLAIL-17ACDK2i
MavuglumideBayerApprovedGLP-1RCDK2i
DSN-3066Daiichi SankyoPhase 3IL-13CDK2i
GIL-9227Gilead SciencesPhase 2/3GPRC5DCDK2i
REG-2328RegeneronPhase 1BCMACDK2i