Modality
ERT
MOA
JAK1i
Target
CD38
Pathway
PD-1/PD-L1
ADHDCervical Ca
Development Pipeline
Preclinical
~Sep 2014
→ ~Dec 2015
Phase 1
~Mar 2016
→ ~Jun 2017
Phase 2
~Sep 2017
→ ~Dec 2018
Phase 3
~Mar 2019
→ ~Jun 2020
NDA/BLA
~Sep 2020
→ ~Dec 2021
Approved
Mar 2022
→ Jul 2031
ApprovedCurrent
NCT07811505
1,835 pts·Cervical Ca
2022-05→2031-07·Completed
NCT05029932
2,007 pts·ADHD
2022-08→2028-05·Recruiting
NCT08247375
987 pts·Cervical Ca
2023-07→2025-07·Completed
+1 more trial
5,275 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-02-051.1y agoPh3 Readout· Cervical Ca
2025-07-188mo agoPh3 Readout· Cervical Ca
2028-05-182.1y awayPh3 Readout· ADHD
2031-07-095.3y awayPh3 Readout· Cervical Ca
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Complet…
Approved
Complet…
Approved
Recruit…
Approved
Complet…
Catalysts
Ph3 Readout
2025-02-05 · 1.1y ago
Cervical Ca
Ph3 Readout
2025-07-18 · 8mo ago
Cervical Ca
Ph3 Readout
2028-05-18 · 2.1y away
ADHD
Ph3 Readout
2031-07-09 · 5.3y away
Cervical Ca
RecruitingCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07811505 | Approved | Cervical Ca | Completed | 1835 | CR |
| NCT05029932 | Approved | ADHD | Recruiting | 2007 | PANSS |
| NCT08247375 | Approved | Cervical Ca | Completed | 987 | Safety |
| NCT08413023 | Approved | Cervical Ca | Completed | 446 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| Geliderotide | Sanofi | Phase 1/2 | PRMT5 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 |