Clinical Trials

Multiple clinical trials sponsored by pharmaceutical developer Boehringer Ingelheim are evaluating brigimadlin across Phase 1, Phase 2, and Phase 3 settings. These studies encompass a broad spectrum of oncological indications, including dedifferentiated liposarcoma, glioblastoma, biliary tract cancer, pancreatic neoplasms, lung neoplasms, bladder cancer, and advanced soft tissue sarcomas. Featuring key late-phase trials such as Brightline-1 and Brightline-4, the overall portfolio's recruitment statuses include completed, active but not recruiting, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06619509 ACTIVE_NOT_RECRUITING
Solid Tumours
Boehringer Ingelheim
 2024-12-30 PHASE2
NCT06370871 WITHDRAWN
Advanced Soft Tissue Sarcoma; Undifferentiated Pleomorphic Sarcoma (UPS); Myxofibrosarcoma (MFS)
Boehringer Ingelheim
 2024-06-27 PHASE3
NCT06058793 COMPLETED
Liposarcoma, Dedifferentiated
Boehringer Ingelheim
 2023-12-13 PHASE3
NCT03449381 COMPLETED
Neoplasms
Boehringer Ingelheim
 2018-06-20 PHASE1
NCT05512377 COMPLETED
Pancreatic Neoplasms; Solid Tumors; Biliary Tract Cancer; Lung Neoplasms; Bladder Cancer
Boehringer Ingelheim
 2022-12-13 PHASE2
NCT05376800 COMPLETED
Glioblastoma
Boehringer Ingelheim
 2022-11-30 PHASE1
NCT03964233 COMPLETED
Neoplasms
Boehringer Ingelheim
 2019-06-20 PHASE1
NCT05218499 COMPLETED
Liposarcoma, Dedifferentiated
Boehringer Ingelheim
 2022-03-31 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the Brigimadlin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brigimadlin acts as a potent inhibitor of the E3 ubiquitin-protein ligase MDM2 by binding MDM2 and blocking its suppression of the tumor suppressor protein p53. This inhibition restores active p53 transcriptional activity and upregulates pro-apoptotic targets such as p21 and PUMA, driving apoptotic cell death and tumor regression in clinical trial settings including dedifferentiated liposarcoma, glioblastoma, and solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.