Modality
Small Molecule
MOA
Anti-Aβ
Target
PCSK9
Pathway
Tau
RBMDDGIST
Development Pipeline
Preclinical
~Sep 2017
→ ~Dec 2018
Phase 1
Mar 2019
→ Nov 2030
Phase 1Current
NCT04732384
2,937 pts·GIST
2023-07→2030-11·Recruiting
NCT08111368
1,594 pts·GIST
2019-03→2029-12·Active
4,531 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-12-068mo awayBTD· RB
2029-12-233.7y awayInterim· GIST
2030-11-204.6y awayInterim· GIST
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P1
Active
P1
Recruit…
Catalysts
BTD
2026-12-06 · 8mo away
RB
Interim
2029-12-23 · 3.7y away
GIST
Interim
2030-11-20 · 4.6y away
GIST
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04732384 | Phase 1 | GIST | Recruiting | 2937 | PASI75 |
| NCT08111368 | Phase 1 | GIST | Active | 1594 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-8369 | Eli Lilly | Approved | Menin | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| BMR-8377 | BioMarin | Phase 1/2 | PCSK9 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| INC-5849 | Incyte | Phase 2 | PCSK9 |