Modality
Gene Therapy
MOA
PD-1i
Target
LAG-3
Pathway
STING
Huntington's
Development Pipeline
Preclinical
~Aug 2010
→ ~Nov 2011
Phase 1
~Feb 2012
→ ~May 2013
Phase 2
~Aug 2013
→ ~Nov 2014
Phase 3
~Feb 2015
→ ~May 2016
NDA/BLA
~Aug 2016
→ ~Nov 2017
Approved
Feb 2018
→ Jun 2030
ApprovedCurrent
NCT03341508
96 pts·Huntington's
2018-02→2026-12·Recruiting
NCT08201633
2,257 pts·Huntington's
2019-05→2027-08·Completed
NCT03725667
600 pts·Huntington's
2020-11→2030-06·Recruiting
+1 more trial
5,474 total pts1 indication
CompletedCurrentUpcoming
Catalysts (5)
2025-04-2511mo agoPh3 Readout· Huntington's
2026-02-092mo agoAdCom· Huntington's
2026-12-058mo awayPh3 Readout· Huntington's
2027-08-061.3y awayPh3 Readout· Huntington's
2030-06-184.2y awayPh3 Readout· Huntington's
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Recruit…
Approved
Complet…
Approved
Recruit…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-04-25 · 11mo ago
Huntington's
AdCom
2026-02-09 · 2mo ago
Huntington's
Ph3 Readout
2026-12-05 · 8mo away
Huntington's
Ph3 Readout
2027-08-06 · 1.3y away
Huntington's
Ph3 Readout
2030-06-18 · 4.2y away
Huntington's
RecruitingCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03341508 | Approved | Huntington's | Recruiting | 96 | LiverFat |
| NCT08201633 | Approved | Huntington's | Completed | 2257 | FEV1 |
| NCT03725667 | Approved | Huntington's | Recruiting | 600 | Mayo |
| NCT05184087 | Approved | Huntington's | Recruiting | 2521 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| ALN-6288 | Alnylam | Approved | LAG-3 | |
| Sovarelsin | Alnylam | Phase 2/3 | LAG-3 | |
| Cevinaritide | Genmab | Phase 2/3 | DLL3 | |
| ZYM-2450 | Zymeworks | Phase 2 | GLP-1R | |
| STO-2663 | Stoke Ther | Approved | LAG-3 | |
| Nidarelsin | Uniqure | Phase 2/3 | RET |