Modality
ERT
MOA
CFTRmod
Target
TIM-3
Pathway
STING
Urothelial Ca
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
~Jan 2018
→ ~Apr 2019
Phase 3
~Jul 2019
→ ~Oct 2020
NDA/BLA
Jan 2021
→ Oct 2028
NDA/BLACurrent
NCT07403817
2,954 pts·Urothelial Ca
2021-01→2028-10·Not yet recruiting
2,954 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-10-262.6y awayPh3 Readout· Urothelial Ca
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2028-10-26 · 2.6y away
Urothelial Ca
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07403817 | NDA/BLA | Urothelial Ca | Not yet recr... | 2954 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Liratinib | Krystal Biotech | NDA/BLA | TIM-3 | |
| Doxazasiran | Axsome | Phase 1 | TIM-3 | |
| Rimanesiran | Merus | Phase 1 | TIM-3 |