← Pipeline|Gozederotide

Gozederotide

NDA/BLA
FRO-9558
Source: Trial-derived·Trials: 2
Modality
Cell Therapy
MOA
Anti-Tau
Target
WEE1
Pathway
STING
LGSNarcolepsyOCD
Development Pipeline
Preclinical
~Jun 2014
~Sep 2015
Phase 1
~Dec 2015
~Mar 2017
Phase 2
~Jun 2017
~Sep 2018
Phase 3
~Dec 2018
~Mar 2020
NDA/BLA
Jun 2020
Oct 2029
NDA/BLACurrent
NCT03790925
900 pts·Narcolepsy
2025-042029-10·Terminated
NCT05318527
156 pts·Narcolepsy
2020-062028-11·Recruiting
1,056 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-10-146mo awayEMA Filing· LGS
2028-11-082.6y awayPh3 Readout· Narcolepsy
2029-10-143.5y awayPh3 Readout· Narcolepsy
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Termina…
Catalysts
EMA Filing
2026-10-14 · 6mo away
LGS
Ph3 Readout
2028-11-08 · 2.6y away
Narcolepsy
Ph3 Readout
2029-10-14 · 3.5y away
Narcolepsy
RecruitingTerminated|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT03790925NDA/BLANarcolepsyTerminated900SeizFreq
NCT05318527NDA/BLANarcolepsyRecruiting156PASI75
Competitors (10)
DrugCompanyPhaseTargetMOA
RHH-7558RochePhase 1SGLT2Anti-Tau
NVS-5439NovartisPreclinicalBETAnti-Tau
NVO-9630Novo NordiskPhase 2CD3Anti-Tau
TAK-2403TakedaPhase 2WEE1BTKi
SovacapivasertibAmgenPhase 3WEE1ALKi
REG-2172RegeneronPhase 1/2PCSK9Anti-Tau
BGN-3305BeiGenePhase 2BCMAAnti-Tau
FixaglumideGenmabPhase 2/3WEE1KIF18Ai
SovarasimodHalozymePhase 1/2WEE1Anti-Tau
VoxamavacamtenCorceptApprovedBETAnti-Tau