Clinical Trials

Sotrastaurin (AEB071) has been evaluated in numerous Phase 1, Phase 1/2, and Phase 2 clinical trials sponsored by pharmaceutical entities and academic institutions. These studies explored its efficacy as an immunosuppressive and antineoplastic agent across diverse conditions, including liver and renal transplantation, plaque psoriasis, and advanced malignancies such as metastatic uveal melanoma and diffuse large B-cell lymphoma. While trials involving healthy volunteers and organ transplantation successfully reached completion, several oncological studies were ultimately terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01430416 COMPLETED
Uveal Melanoma
Novartis Pharmaceuticals
 2011-12-20 PHASE1
NCT02273219 COMPLETED
Uveal Melanoma
Columbia University
 2014-11-19 PHASE1
NCT01854606 COMPLETED
CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma
Novartis Pharmaceuticals
 2013-12-05 PHASE1
NCT01801358 TERMINATED
Uveal Melanoma
Array Biopharma, now a wholly owned subsidiary of Pfizer
 2013-08 PHASE1; PHASE2
NCT02285244 WITHDRAWN
Prolymphocytic Leukemia; Recurrent Mantle Cell Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Richter Syndrome
James Blachly
 2015-03-12 PHASE2
NCT02273219 Completed
Uveal Melanoma
Columbia University
 2014-11-19 Phase 1
NCT01402440 TERMINATED
Diffuse Large B-Cell Lymphoma
Novartis Pharmaceuticals
 2011-11 PHASE1
NCT01801358 Terminated
Uveal Melanoma
Array Biopharma now a wholly owned subsidiary of Pfizer|Array BioPharma
 2013-08 Phase 1|Phase 2
NCT01064791 COMPLETED
Renal Transplantation
Novartis Pharmaceuticals
 2009-12 PHASE2
NCT01128335 COMPLETED
Liver Transplantation
Novartis Pharmaceuticals
 2010-04 PHASE2
NCT00820911 COMPLETED
Kidney Transplantation
Novartis Pharmaceuticals
 2008-09 PHASE2
NCT00572585 COMPLETED
Ulcerative Colitis
Novartis Pharmaceuticals
 2010-04 PHASE2
NCT01430416 Completed
Uveal Melanoma
Novartis Pharmaceuticals|Novartis
 2011-12-20 Phase 1
NCT01402440 Terminated
Diffuse Large B-Cell Lymphoma
Novartis Pharmaceuticals|Novartis
 2011-11 Phase 1
NCT00885196 COMPLETED
Moderate and Severe Plaque Psoriasis
Novartis Pharmaceuticals
 2009-04 PHASE2
NCT00504543 COMPLETED
Kidney Transplantation
Novartis Pharmaceuticals
 2007-07 PHASE2
NCT00615693 COMPLETED
Uveitis; Posterior Uveitis; Panuveitis
Novartis
 2008-07 PHASE2
NCT01594255 COMPLETED
Healthy
Novartis Pharmaceuticals
 2009-07 PHASE1
NCT00545259 COMPLETED
de Novo Liver Transplantation
Novartis
 2007-10 PHASE1
NCT00403416 COMPLETED
Kidney Transplantation
Novartis Pharmaceuticals
 2006-10 PHASE1; PHASE2
NCT00492869 COMPLETED
Kidney Transplantation
Novartis Pharmaceuticals
 2007-01 PHASE1; PHASE2
NCT00555789 TERMINATED
Kidney Transplantation
Novartis Pharmaceuticals
 2007-10 PHASE2
NCT00409929 COMPLETED
Healthy
Novartis
 2006-06 PHASE1
NCT00416546 COMPLETED
Healthy
Novartis
 2006-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-12-19)

Check the Sotrastaurin (AEB071) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sotrastaurin functions as a potent pan-protein kinase C inhibitor that selectively binds PKC family targets to block downstream NF-κB pathway activation, thereby impairing interleukin-2 production, T-cell proliferation, and survival signaling in mutant cells. This inhibition of lymphocyte activation and tumor growth underlies the clinical rationale for investigating Sotrastaurin in graft rejection following liver or renal transplantation and in targeted oncology trials for diffuse large B-cell lymphoma and uveal melanoma.

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.