Volasertib (BI6727) has been evaluated in numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 investigations for advanced solid neoplasms and hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndromes, chronic myelomonocytic leukemia, acute lymphoblastic leukemia, and aggressive lymphomas. Sponsored by industry developer Boehringer Ingelheim alongside academic medical centers such as the University of Ulm, Yale University, and Massachusetts General Hospital, these studies reflect completed, terminated, and withdrawn recruitment statuses across both early safety and advanced clinical development.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02861040 | WITHDRAWN | Recurrent Adult Acute Lymphoblastic Leukemia; Refractory Adult Acute Lymphoblastic Leukemia |
Northwestern University |
2016-08 | PHASE1 |
| NCT02527174 | WITHDRAWN | Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute |
University of Alberta |
2016-11 | PHASE1 |
| NCT02722135 | WITHDRAWN | Leukemia, Myeloid, Acute |
Boehringer Ingelheim |
2016-11 | PHASE1 |
| NCT02875002 | WITHDRAWN | Relapsed and Refractory Aggressive B- and T-cell Lymphomas; Lymphoma |
Yale University |
2016-10 | PHASE1 |
| NCT02905994 | WITHDRAWN | AML |
Massachusetts General Hospital |
2016-09 | PHASE1 |
| NCT01957644 | TERMINATED | Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic |
Boehringer Ingelheim |
2013-11-06 | PHASE1 |
| NCT02722135 | Withdrawn | Leukemia Myeloid Acute |
Boehringer Ingelheim |
2016-11 | Phase 1 |
| NCT02198482 | TERMINATED | Acute Myeloid Leukemia (AML); High-risk Myelodysplastic Syndrome (MDS) |
University of Ulm |
2016-02 | PHASE2 |
| NCT02757248 | WITHDRAWN | PTCL; CTCL |
Anne Beaven, MD |
2016-11 | PHASE1 |
| NCT02721875 | TERMINATED | Myelodysplastic Syndromes |
Boehringer Ingelheim |
2016-04-28 | PHASE1 |
| NCT02721875 | Terminated | Myelodysplastic Syndromes |
Boehringer Ingelheim |
2016-04-28 | Phase 1 |
| NCT01971476 | COMPLETED | Leukemia; Neoplasms |
Boehringer Ingelheim |
2013-10-22 | PHASE1 |
| NCT01662505 | COMPLETED | Leukemia, Myeloid, Acute |
Boehringer Ingelheim |
2012-08 | PHASE1 |
| NCT02003573 | TERMINATED | Leukemia, Myeloid, Acute |
Boehringer Ingelheim |
2014-01-29 | PHASE1 |
| NCT02201329 | COMPLETED | Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic |
Boehringer Ingelheim |
2014-08 | PHASE1 |
| NCT01721876 | COMPLETED | Leukemia, Myeloid, Acute |
Boehringer Ingelheim |
2013-01-29 | PHASE3 |
| NCT02201329 | Completed | Myelodysplastic Syndromes|Leukemia Myelomonocytic Chronic |
Boehringer Ingelheim |
2014-08 | Phase 1 |
| NCT01772563 | COMPLETED | Neoplasms |
Boehringer Ingelheim |
2013-02-04 | PHASE1 |
| NCT01971476 | Completed | Leukemia|Neoplasms |
Boehringer Ingelheim |
2013-10-22 | Phase 1 |
| NCT01772563 | Completed | Neoplasms |
Boehringer Ingelheim |
2013-02-04 | Phase 1 |
| NCT01348347 | COMPLETED | Neoplasms |
Boehringer Ingelheim |
2011-04-25 | PHASE1 |
| NCT01662505 | Completed | Leukemia Myeloid Acute |
Boehringer Ingelheim |
2012-08 | Phase 1 |
| NCT00804856 | COMPLETED | Leukemia, Myeloid, Acute |
Boehringer Ingelheim |
2008-11-27 | PHASE2 |
| NCT01145885 | COMPLETED | Neoplasms |
Boehringer Ingelheim |
2010-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2016-12-15)
Check the
Volasertib (BI6727)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Volasertib (BI6727) Mechanism of Action: PLK1 Inhibition in Leukemia Cell Research
- Volasertib (BI6727) Working Concentration | Cell Culture | Treatment
- Volasertib (BI6727) Solubility in DMSO
- Volasertib (BI6727) Stock Solution
- Volasertib (BI6727) Storage
- Volasertib (BI6727) Stability
- Volasertib (BI6727) Combination Database
- Volasertib (BI6727) Molecular Weight
- Volasertib (BI6727) SMILES
- Volasertib (BI6727) CAS Number
- Volasertib (BI6727) Chemical Structure (2D and 3D)
- Volasertib (BI6727) IC50 for Cell-based and Cell-free Assays
- Volasertib (BI6727) Sigma (SML3641)? Try a better option.
- Volasertib (BI6727) APExBIO (A8558)? Try a better option.
- Volasertib (BI6727) Cayman (18193)? Try a better option.
- Volasertib (BI6727) MedChemExpress (HY-12137)? Try a better option.
- Volasertib (BI6727) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.