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← Pipeline|LLY-4358

LLY-4358

Phase 3
By Eli Lilly
Source: Trial-derived·Trials: 4
Modality
Peptide
MOA
CFTRmod
Target
B7-H3
Pathway
Angiogenesis
NarcolepsyTTR AmyloidosisMigraine
Development Pipeline
Preclinical
~Aug 2012
→ ~Nov 2013
Phase 1
~Feb 2014
→ ~May 2015
Phase 2
~Aug 2015
→ ~Nov 2016
Phase 3
Feb 2017
→ Jan 2031
Phase 3Current
NCT04720742
24 pts·Narcolepsy
2019-06→2028-12·Active
NCT05636754
1,720 pts·Migraine
2017-02→2028-01·Not yet recruiting
NCT05023327
2,429 pts·Migraine
2019-04→2031-01·Terminated
+1 more trial
4,188 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2026-11-107mo awayPh3 Readout· TTR Amyloidosis
2028-01-011.8y awayPh3 Readout· Migraine
2028-12-212.7y awayPh3 Readout· Narcolepsy
2031-01-084.8y awayPh3 Readout· Migraine
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Not yet…
P3
Termina…
P3
Active
P3
Termina…
Catalysts
Ph3 Readout
2026-11-10 · 7mo away
TTR Amyloidosis
Ph3 Readout
2028-01-01 · 1.8y away
Migraine
Ph3 Readout
2028-12-21 · 2.7y away
Narcolepsy
Ph3 Readout
2031-01-08 · 4.8y away
Migraine
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT04720742Phase 3NarcolepsyActive246MWD
NCT05636754Phase 3MigraineNot yet recr...1720BodyWt
NCT05023327Phase 3MigraineTerminated24296MWD
NCT05322076Phase 3TTR AmyloidosisTerminated15EFS
Competitors (10)
DrugCompanyPhaseTargetMOA
CeviglumideRocheNDA/BLAB7-H3CD47i
GelinaritideAbbViePreclinicalFcRnCFTRmod
SNY-9600SanofiNDA/BLAB7-H3PD-L1i
SNY-8628SanofiNDA/BLAB7-H3TYK2i
SNY-9073SanofiPhase 2B7-H3RAS(ON)i
NVO-7840Novo NordiskPhase 2/3B7-H3GLP-1ag
NVO-7872Novo NordiskNDA/BLAB7-H3BTKi
DSN-5254Daiichi SankyoPhase 1B7-H3ALKi
DatozumabRegeneronPhase 1B7-H3USP1i
DarafutibatinibBioNTechPreclinicalPRMT5CFTRmod