Brigimadlin
BI 907828First credible MDM2 inhibitor to reach Phase 3 after two decades of failures. Brightline-1 in dedifferentiated liposarcoma completed enrollment 2024.
Target: MDM2 small-molecule MDM2-p53 inhibitor Boehringer Ingelheim Oncology
When will we know if it works?
AwaitingA positive readout makes MDM2 a validated target for the first time. Hover the badge above for what the confidence level means.
3
Phase 3 trials
0 active · 2 completed · 1 terminated
6
Total trials
P2: 2 · P1: 1
400
Max trial size
across 11 indications
1
Sponsors at target
incl. 2 other assets
What does it do?
MDM2 — Mouse double minute 2 — p53 negative regulator
Modality: small-molecule MDM2-p53 inhibitor
Program: Brightline
The 3 Phase 3 trials
| NCT ID | Indication | N | Status | Started | Primary completion | Readout |
|---|---|---|---|---|---|---|
| NCT05218499 RESULTS | Liposarcoma, Dedifferentiated | 400 | COMPLETED | 2022-03-31 | 2024-04-16 | Read out |
| NCT06058793 | Liposarcoma, Dedifferentiated | 138 | COMPLETED | 2023-12-13 | 2025-12-12 (actual) | Awaiting |
| NCT06370871 | Advanced Soft Tissue Sarcoma; Undifferentiated Pleomorphic Sarcoma (UPS) | — | WITHDRAWN | 2024-06-27 | 2026-07-03 | Stale est. |
What's the case for and against?
✓ What's working in its favor
- Phase 1b: 18% objective response in DDLS, durable >9 months
- First selective MDM2 inhibitor without thrombocytopenia liabilities of prior generation
⚠ What's the biggest risk
- Idasanutlin (Roche): all P3s terminated 2018-2020
- RG7112 / RO5045337 (Roche): discontinued
- Navtemadlin (KRT-232, Kartos): P3 myelofibrosis terminated 2023
- Milademetan (DS-3032b, Daiichi Sankyo / Rain Therapeutics): P3 terminated 2023
Who else is racing? — 2 other assets at MDM2
| Asset | Sponsor | Status |
|---|---|---|
| APG-115 (Alrizomadlin) | Ascentage Pharma | P2 multiple cancers |
| HDM201 (Siremadlin) | Novartis | P2 — most P3s withdrawn |
Source: TheraRadar atomic trial table (built 2026-04-28 from ClinicalTrials.gov v2 API). Trial-target mapping validated via Gemini 2.0 + Gemini 3.1 Lite + Claude Haiku 4.5 multi-LLM consensus, with Claude Sonnet 4.6 arbitration. BD context curated by hand from public disclosures.