Modality
ERT
MOA
TROP-2 ADC
Target
CGRP
Pathway
Sphingolipid
PBC
Development Pipeline
Preclinical
~Jul 2013
→ ~Oct 2014
Phase 1
~Jan 2015
→ ~Apr 2016
Phase 2
~Jul 2016
→ ~Oct 2017
Phase 3
~Jan 2018
→ ~Apr 2019
NDA/BLA
Jul 2019
→ Jun 2028
NDA/BLACurrent
NCT06912980
2,419 pts·PBC
2024-04→2028-06·Active
NCT05134477
423 pts·PBC
2019-07→TBD·Terminated
2,842 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-06-012.2y awayPh3 Readout· PBC
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Termina…
NDA/BLA
Active
Catalysts
Ph3 Readout
2028-06-01 · 2.2y away
PBC
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06912980 | NDA/BLA | PBC | Active | 2419 | 6MWD |
| NCT05134477 | NDA/BLA | PBC | Terminated | 423 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| GMA-5010 | Genmab | Phase 3 | JAK2 | |
| INC-1582 | Incyte | Phase 1/2 | APOC3 | |
| LEG-9870 | Legend Biotech | Phase 1 | CGRP | |
| ASN-4879 | Ascendis Pharma | Phase 3 | CGRP |