Modality
ADC
MOA
MDM2i
Target
AHR
Pathway
T-cell
SCDFSGSPAH
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
~Dec 2017
→ ~Mar 2019
NDA/BLA
Jun 2019
→ Dec 2027
NDA/BLACurrent
NCT06443622
1,571 pts·SCD
2023-07→2027-12·Not yet recruiting
NCT08310681
492 pts·SCD
2019-06→2025-12·Completed
2,063 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-12-084mo agoPh3 Readout· SCD
2027-12-271.7y awayPh3 Readout· SCD
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Complet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2025-12-08 · 4mo ago
SCD
Ph3 Readout
2027-12-27 · 1.7y away
SCD
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06443622 | NDA/BLA | SCD | Not yet recr... | 1571 | LiverFat |
| NCT08310681 | NDA/BLA | SCD | Completed | 492 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR |