Modality
Peptide
MOA
Cl18.2
Target
CGRP
Pathway
PI3K/AKT
PNH
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
~May 2019
→ ~Aug 2020
Phase 2
~Nov 2020
→ ~Feb 2022
Phase 3
~May 2022
→ ~Aug 2023
NDA/BLA
Nov 2023
→ Oct 2026
NDA/BLACurrent
NCT03009089
933 pts·PNH
2023-11→2026-10·Completed
933 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-10-076mo awayPh3 Readout· PNH
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2026-10-07 · 6mo away
PNH
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03009089 | NDA/BLA | PNH | Completed | 933 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| LEG-9870 | Legend Biotech | Phase 1 | CGRP | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| ASN-4879 | Ascendis Pharma | Phase 3 | CGRP | |
| MDG-611 | Madrigal Pharma | Approved | CGRP |