← Pipeline|Semaglumide

Semaglumide

Phase 3
ORC-8613
Source: Trial-derived·Trials: 3
Modality
Degrader
MOA
USP1i
Target
SGLT2
Pathway
mTOR
MyelofibrosisEndometrial CaPV
Development Pipeline
Preclinical
~Jun 2013
~Sep 2014
Phase 1
~Dec 2014
~Mar 2016
Phase 2
~Jun 2016
~Sep 2017
Phase 3
Dec 2017
Aug 2030
Phase 3Current
NCT06813958
1,617 pts·Endometrial Ca
2017-12TBD·Not yet recruiting
NCT05033744
1,617 pts·PV
2022-052030-08·Active
NCT06557258
2,306 pts·Endometrial Ca
2025-042030-03·Recruiting
5,540 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-12-028mo awayPDUFA· Myelofibrosis
2030-03-274.0y awayPh3 Readout· Endometrial Ca
2030-08-114.4y awayPh3 Readout· PV
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Not yet…
P3
Active
P3
Recruit…
Catalysts
PDUFA
2026-12-02 · 8mo away
Myelofibrosis
Ph3 Readout
2030-03-27 · 4.0y away
Endometrial Ca
Ph3 Readout
2030-08-11 · 4.4y away
PV
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT06813958Phase 3Endometrial CaNot yet recr...16176MWD
NCT05033744Phase 3PVActive1617SRI-4
NCT06557258Phase 3Endometrial CaRecruiting2306ORR
Competitors (10)
DrugCompanyPhaseTargetMOA
RHH-7558RochePhase 1SGLT2Anti-Tau
TiramavacamtenRochePreclinicalSGLT2PI3Ki
SNY-2934SanofiPhase 3KRASG12DUSP1i
RimatenlimabNovo NordiskPhase 2/3SGLT2PI3Ki
DSN-7360Daiichi SankyoApprovedSGLT2BiTE
AMG-9052AmgenPhase 2/3CDK2USP1i
DatozumabRegeneronPhase 1B7-H3USP1i
GMA-729GenmabPhase 2BCL-2USP1i
SRP-3270SareptaPhase 1/2SGLT2PI3Ki
TirarapivirUnited TherapeuticsApprovedSGLT2CD47i