Modality
Small Molecule
MOA
CDK2i
Target
SHP2
Pathway
Ferroptosis
MCCPV
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
~Jul 2017
→ ~Oct 2018
Phase 3
~Jan 2019
→ ~Apr 2020
NDA/BLA
Jul 2020
→ May 2030
NDA/BLACurrent
NCT06000171
2,754 pts·PV
2020-07→2030-05·Completed
2,754 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-10-187mo awayAdCom· MCC
2030-05-094.1y awayPh3 Readout· PV
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
NDA/BLA
Complet…
Catalysts
AdCom
2026-10-18 · 7mo away
MCC
Ph3 Readout
2030-05-09 · 4.1y away
PV
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06000171 | NDA/BLA | PV | Completed | 2754 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A |