Modality
Cell Therapy
MOA
Menini
Target
PI3Kα
Pathway
RNA Splicing
SCDAtopic Derm
Development Pipeline
Preclinical
~Aug 2017
→ ~Nov 2018
Phase 1
Feb 2019
→ Dec 2030
Phase 1Current
NCT04844513
1,351 pts·Atopic Derm
2022-03→2030-12·Not yet recruiting
NCT05030337
665 pts·SCD
2019-02→2025-09·Recruiting
2,016 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-09-216mo agoPh2 Data· SCD
2030-12-284.7y awayPh2 Data· Atopic Derm
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P1/2
Recruit…
P1/2
Not yet…
Catalysts
Ph2 Data
2025-09-21 · 6mo ago
SCD
Ph2 Data
2030-12-28 · 4.7y away
Atopic Derm
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04844513 | Phase 1/2 | Atopic Derm | Not yet recr... | 1351 | BodyWt |
| NCT05030337 | Phase 1/2 | SCD | Recruiting | 665 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα |