Modality
Peptide
MOA
Cl18.2
Target
MDM2
Pathway
RAS/MAPK
Thymoma
Development Pipeline
Preclinical
~Sep 2011
→ ~Dec 2012
Phase 1
~Mar 2013
→ ~Jun 2014
Phase 2
~Sep 2014
→ ~Dec 2015
Phase 3
~Mar 2016
→ ~Jun 2017
NDA/BLA
~Sep 2017
→ ~Dec 2018
Approved
Mar 2019
→ May 2030
ApprovedCurrent
NCT03346172
678 pts·Thymoma
2022-09→2030-05·Not yet recruiting
NCT05998123
32 pts·Thymoma
2021-06→2030-02·Active
NCT04095674
2,583 pts·Thymoma
2022-07→2028-03·Not yet recruiting
+1 more trial
5,765 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2025-05-2010mo agoPh3 Readout· Thymoma
2028-03-091.9y awayPh3 Readout· Thymoma
2030-02-203.9y awayPh3 Readout· Thymoma
2030-05-184.1y awayPh3 Readout· Thymoma
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Complet…
Approved
Active
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-05-20 · 10mo ago
Thymoma
Ph3 Readout
2028-03-09 · 1.9y away
Thymoma
Ph3 Readout
2030-02-20 · 3.9y away
Thymoma
Ph3 Readout
2030-05-18 · 4.1y away
Thymoma
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03346172 | Approved | Thymoma | Not yet recr... | 678 | PASI75 |
| NCT05998123 | Approved | Thymoma | Active | 32 | DOR |
| NCT04095674 | Approved | Thymoma | Not yet recr... | 2583 | CR |
| NCT04012603 | Approved | Thymoma | Completed | 2472 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| SRP-1135 | Sarepta | Phase 2/3 | MDM2 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 |