Modality
siRNA
MOA
AHRant
Target
TIM-3
Pathway
Epigenetic
Pancreatic CaLGSGBM
Development Pipeline
Preclinical
~Aug 2013
→ ~Nov 2014
Phase 1
~Feb 2015
→ ~May 2016
Phase 2
~Aug 2016
→ ~Nov 2017
Phase 3
~Feb 2018
→ ~May 2019
NDA/BLA
~Aug 2019
→ ~Nov 2020
Approved
Feb 2021
→ Jun 2030
ApprovedCurrent
NCT04625175
1,368 pts·LGS
2021-02→2030-06·Completed
NCT05128204
1,972 pts·LGS
2024-05→2028-11·Terminated
3,340 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2028-11-252.7y awayPh3 Readout· LGS
2030-06-264.2y awayPh3 Readout· LGS
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2028-11-25 · 2.7y away
LGS
Ph3 Readout
2030-06-26 · 4.2y away
LGS
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04625175 | Approved | LGS | Completed | 1368 | SeizFreq |
| NCT05128204 | Approved | LGS | Terminated | 1972 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| BII-5449 | Biogen | Phase 3 | FXIa | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| Elratapinarof | Halozyme | Phase 2 | C5 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| Liratinib | Krystal Biotech | NDA/BLA | TIM-3 | |
| NTL-2576 | Intellia | NDA/BLA | SGLT2 | |
| Doxazasiran | Axsome | Phase 1 | TIM-3 | |
| Rimanesiran | Merus | Phase 1 | TIM-3 |