Clinical Trials

Numerous clinical trials across Phase 1, Phase 2, and Phase 3 have evaluated afuresertib primarily in oncology—targeting conditions such as triple-negative breast cancer, platinum-resistant ovarian cancer, metastatic castration-resistant prostate cancer, non-small cell lung cancer, hematologic malignancies, and solid tumors—as well as in healthy volunteers. Sponsored by entities including Laekna Limited, GlaxoSmithKline, Novartis, and University Health Network Toronto, these studies encompass various recruitment statuses, including completed, active not recruiting, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04851613 ACTIVE_NOT_RECRUITING
Breast Cancer
Laekna Limited
 2022-02-18 PHASE3
NCT05383482 COMPLETED
Solid Tumor; NSCLC; Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Gastric and Gastroesophageal Junction Adenocarcinoma
Laekna Limited
 2022-07-01 PHASE1; PHASE2
NCT04060394 COMPLETED
Metastatic Castration-resistant Prostate Cancer
Laekna Limited
 2019-09-13 PHASE1; PHASE2
NCT05390710 COMPLETED
Solid Tumor; TNBC - Triple-Negative Breast Cancer
Laekna Limited
 2021-06-12 PHASE1
NCT04374630 COMPLETED
Platinum-resistant Ovarian Cancer
Laekna Limited
 2020-06-09 PHASE2
NCT05489744 COMPLETED
Healthy Volunteer
Laekna Limited
 2022-08-06 PHASE1
NCT05489744 Completed
Healthy Volunteer
Laekna Limited
 2022-08-06 Phase 1
NCT05390710 Completed
Solid Tumor|TNBC - Triple-Negative Breast Cancer
Laekna Limited
 2021-06-12 Phase 1
NCT04374630 Active not recruiting
Platinum-resistant Ovarian Cancer
Laekna Limited
 2020-06-09 Phase 2
NCT04060394 Active not recruiting
Metastatic Castration-resistant Prostate Cancer
Laekna Limited
 2019-09-13 Phase 1|Phase 2
NCT01531894 COMPLETED
Cancer
Novartis Pharmaceuticals
 2012-02-08 PHASE2
NCT01532700 COMPLETED
Chronic Lymphocytic Leukemia (CLL)
University Health Network, Toronto
 2012-02 PHASE2
NCT02380313 WITHDRAWN
Cancer
GlaxoSmithKline
 2015-10 PHASE1
NCT02177682 TERMINATED
Neoplasms, Haematologic
Novartis Pharmaceuticals
 2014-08-13 PHASE1
NCT02240212 COMPLETED
Cancer
Novartis Pharmaceuticals
 2014-10 PHASE1
NCT02235740 TERMINATED
Cancer
Novartis
 2014-11 PHASE1
NCT01428492 COMPLETED
Multiple Myeloma
Novartis
 2011-12 PHASE1
NCT01653912 COMPLETED
Recurrent Platinum-resistant Ovarian Cancer
Accenture
 2012-11 PHASE1; PHASE2
NCT02235740 Terminated
Cancer
Novartis|Amgen
 2014-11 Phase 1
NCT02040480 COMPLETED
Cancer
GlaxoSmithKline
 2014-02-05 PHASE1
NCT01395004 COMPLETED
Langerhans Cell Histiocytosis
GlaxoSmithKline
 2011-11 PHASE2
NCT01827644 COMPLETED
Cancer
GlaxoSmithKline
 2013-04-24 PHASE1
NCT01476137 COMPLETED
Cancer
GlaxoSmithKline
 2011-10-26 PHASE1
NCT00881946 COMPLETED
Hematologic Malignancies
Accenture
 2009-07 PHASE1; PHASE2
NCT01445587 WITHDRAWN
Cancer
GlaxoSmithKline
 2011-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Afuresertib (GSK2110183) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Afuresertib selectively binds to and inhibits the serine/threonine kinase Akt isoforms Akt1, Akt2, and Akt3, thereby suppressing downstream PI3K/Akt signaling pathway activation and reducing pro-survival signal transduction. This inhibition halts tumor cell proliferation and triggers apoptotic cell death, demonstrating clinical relevance in suppressing tumor growth across Akt-dependent malignancies such as triple-negative breast cancer, ovarian cancer, and prostate 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>).

Jump to

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