Modality
Gene Editing
MOA
CGRPant
Target
GIP-R
Pathway
Proteasome
MDDTTR Amyloidosis
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Feb 2030
ApprovedCurrent
NCT04577222
877 pts·MDD
2025-12→TBD·Not yet recruiting
NCT05931525
1,632 pts·TTR Amyloidosis
2017-01→2030-02·Recruiting
2,509 total pts2 indications
CompletedCurrentUpcoming
Catalysts (1)
2030-02-153.9y awayPh3 Readout· TTR Amyloidosis
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Recruit…
Approved
Not yet…
Catalysts
Ph3 Readout
2030-02-15 · 3.9y away
TTR Amyloidosis
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04577222 | Approved | MDD | Not yet recr... | 877 | HbA1c |
| NCT05931525 | Approved | TTR Amyloidosis | Recruiting | 1632 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Tezecilimab | Regeneron | Approved | IL-23 |