Modality
ERT
MOA
BCMA ADC
Target
SGLT2
Pathway
RNA Splicing
AMLNSCLC
Development Pipeline
Preclinical
~Aug 2009
→ ~Nov 2010
Phase 1
~Feb 2011
→ ~May 2012
Phase 2
~Aug 2012
→ ~Nov 2013
Phase 3
~Feb 2014
→ ~May 2015
NDA/BLA
~Aug 2015
→ ~Nov 2016
Approved
Feb 2017
→ Mar 2029
ApprovedCurrent
NCT05414475
1,413 pts·AML
2025-01→2025-06·Recruiting
NCT07587164
1,470 pts·AML
2017-12→2029-03·Completed
NCT03153021
1,298 pts·NSCLC
2017-02→2027-09·Recruiting
+1 more trial
6,703 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-06-159mo agoPh3 Readout· AML
2026-03-034w agoPh3 Readout· AML
2027-09-211.5y awayPh3 Readout· NSCLC
2029-03-193.0y awayPh3 Readout· AML
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Recruit…
Approved
Complet…
Approved
Not yet…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-06-15 · 9mo ago
AML
Ph3 Readout
2026-03-03 · 4w ago
AML
Ph3 Readout
2027-09-21 · 1.5y away
NSCLC
Ph3 Readout
2029-03-19 · 3.0y away
AML
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05414475 | Approved | AML | Recruiting | 1413 | DAS28 |
| NCT07587164 | Approved | AML | Completed | 1470 | FEV1 |
| NCT03153021 | Approved | NSCLC | Recruiting | 1298 | FEV1 |
| NCT03918975 | Approved | AML | Not yet recr... | 2522 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| SRP-3270 | Sarepta | Phase 1/2 | SGLT2 | |
| Tirarapivir | United Therapeutics | Approved | SGLT2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 |