Modality
Gene Editing
MOA
CAR-T BCMA
Target
FGFR
Pathway
Ferroptosis
ObesityADPKD
Development Pipeline
Preclinical
~Apr 2012
→ ~Jul 2013
Phase 1
~Oct 2013
→ ~Jan 2015
Phase 2
~Apr 2015
→ ~Jul 2016
Phase 3
~Oct 2016
→ ~Jan 2018
NDA/BLA
~Apr 2018
→ ~Jul 2019
Approved
Oct 2019
→ Jul 2026
ApprovedCurrent
NCT03608218
1,757 pts·ADPKD
2019-10→2025-01·Completed
NCT08578461
2,142 pts·Obesity
2020-01→2026-07·Completed
NCT05071541
589 pts·ADPKD
2021-10→TBD·Completed
4,488 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-01-251.2y agoPh3 Readout· ADPKD
2026-07-214mo awayPh3 Readout· Obesity
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3
Approved
Complet…
Approved
Complet…
Approved
Complet…
Catalysts
Ph3 Readout
2025-01-25 · 1.2y ago
ADPKD
Ph3 Readout
2026-07-21 · 4mo away
Obesity
Completed|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03608218 | Approved | ADPKD | Completed | 1757 | PASI75 |
| NCT08578461 | Approved | Obesity | Completed | 2142 | Safety |
| NCT05071541 | Approved | ADPKD | Completed | 589 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxacilimab | Pfizer | Phase 2 | TYK2 | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| NVO-9087 | Novo Nordisk | Phase 1/2 | Tau | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn | |
| ACA-2691 | Acadia Pharma | Phase 3 | BCMA |