Modality
mAb
MOA
Menini
Target
CD38
Pathway
Fibrosis
ADPKDHeart FailureAlzheimer's
Development Pipeline
Preclinical
~Jun 2022
→ ~Sep 2023
Phase 1
Dec 2023
→ Feb 2031
Phase 1Current
NCT06450807
2,336 pts·ADPKD
2025-12→2029-02·Recruiting
NCT05314823
2,154 pts·ADPKD
2023-12→2031-02·Active
4,490 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-02-192.9y awayPh2 Data· ADPKD
2031-02-144.9y awayPh2 Data· ADPKD
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P1/2
Active
P1/2
Recruit…
Catalysts
Ph2 Data
2029-02-19 · 2.9y away
ADPKD
Ph2 Data
2031-02-14 · 4.9y away
ADPKD
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06450807 | Phase 1/2 | ADPKD | Recruiting | 2336 | OS |
| NCT05314823 | Phase 1/2 | ADPKD | Active | 2154 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 |