Modality
siRNA
MOA
GLP-1ag
Target
KIF18A
Pathway
T-cell
ACCADPKD
Development Pipeline
Preclinical
~Nov 2011
→ ~Feb 2013
Phase 1
~May 2013
→ ~Aug 2014
Phase 2
~Nov 2014
→ ~Feb 2016
Phase 3
~May 2016
→ ~Aug 2017
NDA/BLA
~Nov 2017
→ ~Feb 2019
Approved
May 2019
→ Feb 2030
ApprovedCurrent
NCT07572384
2,218 pts·ACC
2022-11→2025-11·Not yet recruiting
NCT05501447
2,447 pts·ADPKD
2019-05→2028-04·Recruiting
NCT07816425
2,382 pts·ADPKD
2021-12→TBD·Active
+1 more trial
8,222 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-11-095mo agoPh3 Readout· ACC
2028-04-192.1y awayPh3 Readout· ADPKD
2030-02-253.9y awayPh3 Readout· ACC
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Recruit…
Approved
Active
Approved
Not yet…
Approved
Complet…
Catalysts
Ph3 Readout
2025-11-09 · 5mo ago
ACC
Ph3 Readout
2028-04-19 · 2.1y away
ADPKD
Ph3 Readout
2030-02-25 · 3.9y away
ACC
RecruitingActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07572384 | Approved | ACC | Not yet recr... | 2218 | BodyWt |
| NCT05501447 | Approved | ADPKD | Recruiting | 2447 | HbA1c |
| NCT07816425 | Approved | ADPKD | Active | 2382 | DAS28 |
| NCT04229570 | Approved | ACC | Completed | 1175 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| MRN-7601 | Moderna | Phase 2 | IL-13 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| ARG-1250 | Argenx | Phase 2 | C5 | |
| ILM-5680 | Illumina | Phase 2 | BET | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| CRS-184 | CRISPR Therapeutics | Phase 1/2 | AHR | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A |