Modality
Small Molecule
MOA
AuroraAi
Target
CDK4/6
Pathway
Angiogenesis
FabryRAPAH
Development Pipeline
Preclinical
~Jul 2016
→ ~Oct 2017
Phase 1
~Jan 2018
→ ~Apr 2019
Phase 2
~Jul 2019
→ ~Oct 2020
Phase 3
~Jan 2021
→ ~Apr 2022
NDA/BLA
Jul 2022
→ Nov 2025
NDA/BLACurrent
NCT08963635
1,694 pts·Fabry
2022-07→2025-11·Active
1,694 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-11-224mo agoPh3 Readout· Fabry
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2025-11-22 · 4mo ago
Fabry
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08963635 | NDA/BLA | Fabry | Active | 1694 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| Elralucimab | Axsome | Phase 2 | CDK4/6 |