Modality
Small Molecule
MOA
FcRni
Target
GIP-R
Pathway
Lipid Met
Rett
Development Pipeline
Preclinical
~Nov 2018
→ ~Feb 2020
Phase 1
~May 2020
→ ~Aug 2021
Phase 2
~Nov 2021
→ ~Feb 2023
Phase 3
~May 2023
→ ~Aug 2024
NDA/BLA
Nov 2024
→ Jun 2026
NDA/BLACurrent
NCT07083717
2,277 pts·Rett
2024-11→2026-06·Completed
2,277 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-06-092mo awayPh3 Readout· Rett
Trial Timeline
2025Q2Q3Q42026Q2
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2026-06-09 · 2mo away
Rett
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07083717 | NDA/BLA | Rett | Completed | 2277 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 | |
| Capifutibatinib | Intra-Cellular | Phase 3 | GIP-R |