Modality
mRNA
MOA
MDM2i
Target
FcRn
Pathway
PI3K/AKT
IgANOCDAsthma
Development Pipeline
Preclinical
~Sep 2012
→ ~Dec 2013
Phase 1
~Mar 2014
→ ~Jun 2015
Phase 2
~Sep 2015
→ ~Dec 2016
Phase 3
Mar 2017
→ Dec 2027
Phase 3Current
NCT06577376
2,919 pts·Asthma
2022-07→TBD·Not yet recruiting
NCT05466491
1,001 pts·IgAN
2017-03→2027-07·Not yet recruiting
NCT03770401
1,263 pts·IgAN
2022-07→2027-12·Recruiting
5,183 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-07-181.3y awayPh3 Readout· IgAN
2027-12-051.7y awayPh3 Readout· IgAN
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P3
Not yet…
P3
Not yet…
P3
Recruit…
Catalysts
Ph3 Readout
2027-07-18 · 1.3y away
IgAN
Ph3 Readout
2027-12-05 · 1.7y away
IgAN
RecruitingNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06577376 | Phase 3 | Asthma | Not yet recr... | 2919 | CR |
| NCT05466491 | Phase 3 | IgAN | Not yet recr... | 1001 | Safety |
| NCT03770401 | Phase 3 | IgAN | Recruiting | 1263 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| ITC-879 | Intra-Cellular | Approved | FcRn |