Enzastaurin has been evaluated in numerous Phase 1, Phase 2, and Phase 3 clinical trials across hematologic malignancies—such as diffuse large B-cell lymphoma and cutaneous T-cell lymphoma—and solid tumors, including glioblastoma multiforme, metastatic renal cell carcinoma, and prostate cancer. Sponsored by industry entities including Eli Lilly and Denovo Biopharma, as well as research networks like the National Cancer Institute and EORTC, trial recruitment statuses vary, with many completed alongside several terminated, withdrawn, suspended, or unknown entries.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05463679 | SUSPENDED | Vascular Ehlers-Danlos Syndrome |
Aytu BioPharma, Inc. |
2025-01 | PHASE3 |
| NCT03776071 | COMPLETED | Glioblastoma |
Denovo Biopharma LLC |
2020-12-16 | PHASE3 |
| NCT03263026 | COMPLETED | Diffuse Large B-Cell Lymphoma |
Denovo Biopharma LLC |
2018-03-20 | PHASE3 |
| NCT03263026 | Completed | Diffuse Large B-Cell Lymphoma |
Denovo Biopharma LLC |
2018-03-20 | Phase 3 |
| NCT00407758 | COMPLETED | Ovarian Cancer; Primary Peritoneal Cavity Cancer |
Gynecologic Oncology Group |
2006-11 | PHASE2 |
| NCT00108056 | TERMINATED | Glioma |
National Cancer Institute (NCI) |
2005-04-07 | PHASE1 |
| NCT00586508 | COMPLETED | Recurrent Glioblastoma |
Eli Lilly and Company |
2007-11 | PHASE2 |
| NCT01445119 | COMPLETED | Recurrent Gliomas |
Eli Lilly and Company |
2007-01 | PHASE1 |
| NCT00332202 | COMPLETED | Non Hodgkin Lymphoma |
Eli Lilly and Company |
2006-06 | PHASE3 |
| NCT01432951 | COMPLETED | Solid Tumor; Lymphoma, Malignant |
Eli Lilly and Company |
2011-11 | PHASE1 |
| NCT01388335 | COMPLETED | Solid Tumor; Lymphoma, Malignant |
Eli Lilly and Company |
2011-08 | PHASE1 |
| NCT00475644 | COMPLETED | Lymphoma, Follicular |
Eli Lilly and Company |
2007-05 | PHASE2 |
| NCT00451178 | COMPLETED | Lymphoma |
Eli Lilly and Company |
2007-05 | PHASE2 |
| NCT01432951 | Completed | Solid Tumor|Lymphoma Malignant |
Eli Lilly and Company |
2011-11 | Phase 1 |
| NCT01388335 | Completed | Solid Tumor|Lymphoma Malignant |
Eli Lilly and Company |
2011-08 | Phase 1 |
| NCT00415363 | COMPLETED | Non Small Cell Lung Cancer; Small Cell Lung Cancer |
Eli Lilly and Company |
2006-12 | PHASE2 |
| NCT00451555 | COMPLETED | Breast Cancer |
Eli Lilly and Company |
2007-04-11 | PHASE2 |
| NCT00718419 | COMPLETED | Waldenstrom's Macroglobulinemia; Multiple Myeloma |
Eli Lilly and Company |
2008-07 | PHASE2 |
| NCT00414960 | COMPLETED | Lung Cancer |
Eli Lilly and Company |
2007-12 | PHASE2 |
| NCT00685633 | WITHDRAWN | Prostate Cancer |
Eastern Cooperative Oncology Group |
2008-12 | PHASE2 |
| NCT00503724 | COMPLETED | Brain and Central Nervous System Tumors; Neuroblastoma |
Pediatric Brain Tumor Consortium |
2007-06 | PHASE1 |
| NCT00391118 | COMPLETED | Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Neoplasm |
Eli Lilly and Company |
2006-11 | PHASE2 |
| NCT00542919 | COMPLETED | T-Cell Lymphoma; B-Cell Lymphoma |
Eli Lilly and Company |
2007-11 | PHASE2 |
| NCT00550927 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Eli Lilly and Company |
2006-11 | PHASE1 |
| NCT00709995 | COMPLETED | Metastatic Renal Cell Carcinoma |
Eli Lilly and Company |
2008-06-30 | PHASE2 |
| NCT00509821 | COMPLETED | Glioblastoma Multiforme |
Eli Lilly and Company |
2007-10 | PHASE2 |
| NCT00612586 | COMPLETED | Colorectal Cancer |
Eli Lilly and Company |
2008-02 | PHASE2 |
| NCT00744991 | COMPLETED | Cutaneous T-Cell Lymphoma |
Eli Lilly and Company |
2008-09 | PHASE2 |
| NCT00402116 | COMPLETED | Glioblastoma; Glioblastoma Multiforme; Gliosarcoma |
Eli Lilly and Company |
2006-09 | PHASE1; PHASE2 |
| NCT00436280 | COMPLETED | Lymphoma, Large Cell, Diffuse |
Eli Lilly and Company |
2007-02 | PHASE2 |
| NCT00466440 | COMPLETED | Prostate Cancer |
Eli Lilly and Company |
2007-06 | PHASE2 |
| NCT00309140 | COMPLETED | Neoplasms; Cancer |
Eli Lilly and Company |
2006-03 | PHASE2 |
| NCT00308750 | COMPLETED | Non-Small Cell Lung Cancer |
Eli Lilly and Company |
2006-03 | PHASE2 |
| NCT00452413 | COMPLETED | Non-Small Cell Lung Cancer; Malignant Solid Tumor |
Eli Lilly and Company |
2007-05 | PHASE1; PHASE2 |
| NCT00428714 | COMPLETED | Prostate Cancer |
Eli Lilly and Company |
2007-01 | PHASE2 |
| NCT00437268 | COMPLETED | Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumor |
Eli Lilly and Company |
2007-03 | PHASE2 |
| NCT00437294 | TERMINATED | Breast Cancer |
Eli Lilly and Company |
2007-03 | PHASE2 |
| NCT00533429 | COMPLETED | Non-small Cell Lung Cancer |
Eli Lilly and Company |
2007-10 | PHASE2 |
| NCT00516607 | UNKNOWN | Brain and Central Nervous System Tumors |
European Organisation for Research and Treatment of Cancer - EORTC |
2007-07 | PHASE1 |
| NCT00538681 | TERMINATED | Lung Cancer |
Eli Lilly and Company |
2007-09 | PHASE2 |
| NCT00530621 | COMPLETED | Non-small Cell Lung Cancer |
Eli Lilly and Company |
2007-09 | PHASE2 |
| NCT00744991 | Completed | Cutaneous T-Cell Lymphoma |
Eli Lilly and Company |
2008-09 | Phase 2 |
| NCT00452257 | COMPLETED | Leukemia, Lymphocytic |
Eli Lilly and Company |
2007-05 | PHASE1 |
| NCT00709995 | Completed | Metastatic Renal Cell Carcinoma |
Eli Lilly and Company |
2008-06-30 | Phase 2 |
| NCT00420381 | COMPLETED | Ovarian Cancer; Neoplasms; Carcinoma |
Eli Lilly and Company |
2007-01 | PHASE2 |
| NCT00267020 | COMPLETED | Pancreatic Neoplasm |
Eli Lilly and Company |
2005-12 | PHASE2 |
| NCT00088205 | COMPLETED | Mantle-Cell Lymphoma |
Eli Lilly and Company |
2004-03 | PHASE2 |
| NCT00536939 | TERMINATED | Breast Cancer |
Eli Lilly and Company |
2007-11 | PHASE2 |
| NCT00192114 | COMPLETED | Colonic Neoplasms |
Eli Lilly and Company |
2005-08 | PHASE2 |
| NCT00295815 | COMPLETED | Glioblastoma |
Eli Lilly and Company |
2006-01 | PHASE3 |
| NCT00052273 | COMPLETED | Adult; Solid Tumor |
Jonsson Comprehensive Cancer Center |
2002-12 | PHASE1 |
| NCT00386087 | COMPLETED | Breast Neoplasms |
Eli Lilly and Company |
2006-11 | PHASE2 |
| NCT00469976 | WITHDRAWN | Lung Cancer |
Eastern Cooperative Oncology Group |
2007-06 | PHASE2 |
| NCT00190723 | COMPLETED | Malignant Glioma |
Eli Lilly and Company |
2002-10 | PHASE2 |
| NCT00105092 | COMPLETED | Non-Small-Cell Lung Carcinoma |
Eli Lilly and Company |
2005-03 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2024-03-08)
Check the
Enzastaurin
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>).
Note: Technical data last updated: Sep 1, 2026.