Modality
Radioligand
MOA
DLL3 ADC
Target
FcRn
Pathway
Amyloid
ADHDCholangiocarcinomaGA
Development Pipeline
Preclinical
~Nov 2013
→ ~Feb 2015
Phase 1
~May 2015
→ ~Aug 2016
Phase 2
~Nov 2016
→ ~Feb 2018
Phase 3
May 2018
→ Nov 2026
Phase 3Current
NCT06187326
1,836 pts·ADHD
2023-09→2026-11·Not yet recruiting
NCT03170680
559 pts·ADHD
2024-07→2026-09·Recruiting
NCT06446233
1,849 pts·Cholangiocarcinoma
2018-05→2025-11·Completed
4,244 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-204mo agoPh3 Readout· Cholangiocarcinoma
2026-09-266mo awayPh3 Readout· ADHD
2026-11-117mo awayPh3 Readout· ADHD
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P3
Complet…
P3
Not yet…
P3
Recruit…
Catalysts
Ph3 Readout
2025-11-20 · 4mo ago
Cholangiocarcinoma
Ph3 Readout
2026-09-26 · 6mo away
ADHD
Ph3 Readout
2026-11-11 · 7mo away
ADHD
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06187326 | Phase 3 | ADHD | Not yet recr... | 1836 | EDSS |
| NCT03170680 | Phase 3 | ADHD | Recruiting | 559 | PANSS |
| NCT06446233 | Phase 3 | Cholangiocarcinoma | Completed | 1849 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn | |
| Tixatapinarof | Arvinas | Phase 1/2 | CDK2 |