Modality
Small Molecule
MOA
TNFi
Target
PLK4
Pathway
NF-κB
MDS
Development Pipeline
Preclinical
~Mar 2012
→ ~Jun 2013
Phase 1
~Sep 2013
→ ~Dec 2014
Phase 2
~Mar 2015
→ ~Jun 2016
Phase 3
~Sep 2016
→ ~Dec 2017
NDA/BLA
~Mar 2018
→ ~Jun 2019
Approved
Sep 2019
→ Jun 2029
ApprovedCurrent
NCT03799127
268 pts·MDS
2019-09→2027-04·Not yet recruiting
NCT07377246
122 pts·MDS
2019-09→2027-02·Active
NCT04101645
2,369 pts·MDS
2025-11→2029-02·Recruiting
+1 more trial
3,868 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2027-02-1010mo awayPh3 Readout· MDS
2027-04-051.0y awayPh3 Readout· MDS
2029-02-052.9y awayPh3 Readout· MDS
2029-06-243.2y awayPh3 Readout· MDS
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
Approved
Not yet…
Approved
Active
Approved
Recruit…
Approved
Recruit…
Catalysts
Ph3 Readout
2027-02-10 · 10mo away
MDS
Ph3 Readout
2027-04-05 · 1.0y away
MDS
Ph3 Readout
2029-02-05 · 2.9y away
MDS
Ph3 Readout
2029-06-24 · 3.2y away
MDS
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03799127 | Approved | MDS | Not yet recr... | 268 | LiverFat |
| NCT07377246 | Approved | MDS | Active | 122 | HbA1c |
| NCT04101645 | Approved | MDS | Recruiting | 2369 | SRI-4 |
| NCT05024963 | Approved | MDS | Recruiting | 1109 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| ILM-2412 | Illumina | Phase 3 | PLK4 |