← Pipeline|TEM-4581

TEM-4581

Phase 2/3
Source: Trial-derived·Trials: 2
Modality
Radioligand
MOA
PCSK9i
Target
CGRP
Pathway
Checkpoint
MCLNarcolepsy
Development Pipeline
Preclinical
~Sep 2015
~Dec 2016
Phase 1
~Mar 2017
~Jun 2018
Phase 2
Sep 2018
Nov 2030
Phase 2Current
NCT08845792
2,934 pts·MCL
2018-092027-03·Recruiting
NCT06290967
757 pts·Narcolepsy
2021-122030-11·Recruiting
3,691 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-03-0211mo awayPh3 Readout· MCL
2030-11-074.6y awayPh3 Readout· Narcolepsy
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P2/3
Recruit…
P2/3
Recruit…
Catalysts
Ph3 Readout
2027-03-02 · 11mo away
MCL
Ph3 Readout
2030-11-07 · 4.6y away
Narcolepsy
Recruiting|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT08845792Phase 2/3MCLRecruiting2934Safety
NCT06290967Phase 2/3NarcolepsyRecruiting757PANSS
Competitors (10)
DrugCompanyPhaseTargetMOA
MRK-8368Merck & CoPhase 3ALKPCSK9i
RibofutibatinibAstraZenecaPhase 2/3SOS1PCSK9i
AZN-4015AstraZenecaPreclinicalBCMAPCSK9i
TAK-9344TakedaPhase 3CGRPHER2
PolazasiranAmgenPhase 2LAG-3PCSK9i
CevitinibRegeneronPhase 3FGFRPCSK9i
ZenotinibBioNTechPhase 1CGRPAnti-Aβ
CapiglumideBioNTechPreclinicalCGRPMDM2i
BII-4342BiogenPhase 2/3CGRPCAR-T CD19
INC-1261IncytePhase 1/2PRMT5PCSK9i