Modality
ADC
MOA
BiTE
Target
SMN2
Pathway
RNA Splicing
RBHS
Development Pipeline
Preclinical
~Dec 2013
→ ~Mar 2015
Phase 1
~Jun 2015
→ ~Sep 2016
Phase 2
~Dec 2016
→ ~Mar 2018
Phase 3
~Jun 2018
→ ~Sep 2019
NDA/BLA
~Dec 2019
→ ~Mar 2021
Approved
Jun 2021
→ Feb 2031
ApprovedCurrent
NCT06588829
460 pts·HS
2021-06→2031-02·Recruiting
NCT03411153
592 pts·HS
2024-12→2027-08·Active
1,052 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2027-08-251.4y awayPh3 Readout· HS
2031-02-024.8y awayPh3 Readout· HS
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2027-08-25 · 1.4y away
HS
Ph3 Readout
2031-02-02 · 4.8y away
HS
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06588829 | Approved | HS | Recruiting | 460 | NT-proBNP |
| NCT03411153 | Approved | HS | Active | 592 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Geliglumide | Samsung Biologics | Phase 1 | Aβ |