Clinical Trials

Multiple clinical trials have evaluated triciribine in Phase 1 and Phase 1/2 studies across hematologic malignancies, such as acute leukemia and mucosa-associated lymphoid tissue lymphoma, and solid tumors, including breast adenocarcinoma and ovarian cancer. Sponsored by Prescient Therapeutics, VioQuest Pharmaceuticals, and National Taiwan University Hospital, these investigations characterized triciribine's safety, pharmacokinetics, and combination efficacy in advanced or refractory cancers. Recruitment statuses vary, spanning completed trials in hematologic and solid malignancies to terminated protocols in recurrent breast carcinoma and platinum-resistant ovarian cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02930109 COMPLETED
Acute Leukemia
Prescient Therapeutics, Ltd.
2016-12-09 PHASE1; PHASE2
NCT01697293 TERMINATED
Breast Adenocarcinoma; Estrogen Receptor Positive; HER2/Neu Negative; Recurrent Breast Carcinoma; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
Prescient Therapeutics, Ltd.
2012-01 PHASE1; PHASE2
NCT01690468 TERMINATED
Ovarian Cancer
Prescient Therapeutics, Ltd.
2014-09 PHASE1; PHASE2
NCT02987127 Unknown status
Mucosa-Associated Lymphoid Tissue Lymphoma
National Taiwan University Hospital
2016-02 --
NCT00642031 COMPLETED
Hematologic Malignancies; Leukemia
Prescient Therapeutics, Ltd.
2006-08 PHASE1
NCT00363454 COMPLETED
Cancer
Prescient Therapeutics, Ltd.
2006-04 PHASE1
NCT00642031 Completed
Hematologic Malignancies|Leukemia
Prescient Therapeutics Ltd.|VioQuest Pharmaceuticals
2006-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-04-05)

Check the Triciribine (API-2) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Triciribine selectively inhibits the phosphorylation and activation of Akt1, Akt2, and Akt3 without directly blocking upstream PI3K or PDK1, thereby disrupting downstream survival signaling and triggering apoptosis in Akt-dependent cells. This targeted suppression of Akt activation leads to cell growth arrest and tumor growth inhibition, providing therapeutic rationale for its clinical evaluation in Akt-driven malignancies such as acute leukemia, breast adenocarcinoma, and ovarian cancer.

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.