Clinical Trials

Multiple clinical trials sponsored by entities such as Chipscreen Biosciences Ltd. and Akeso evaluate chiauranib across Phase 1 through Phase 3 studies in healthy volunteers and patients with solid or hematologic malignancies. These investigations cover conditions including small cell lung cancer, metastatic pancreatic ductal adenocarcinoma, ovarian cancer, non-Hodgkin's lymphoma, hepatocellular carcinoma, and soft tissue sarcoma. Ranging in status from completed, active, and recruiting to terminated and planned studies, these trials assess the drug's safety, pharmacokinetics, and efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07445295 NOT_YET_RECRUITING
Metastatic Pancreatic Ductal Adenocarcinoma
Chipscreen Biosciences, Ltd.
 2026-03-31 PHASE3
NCT06492915 ACTIVE_NOT_RECRUITING
Pancreatic Ductal Adenocarcinoma
Chipscreen Biosciences, Ltd.
 2024-08-13 PHASE2
NCT05271292 UNKNOWN
Small Cell Lung Cancer; Advanced Solid Malignant Tumor
Chipscreen Biosciences, Ltd.
 2022-08-26 PHASE1; PHASE2
NCT05497843 COMPLETED
Soft Tissue Sarcoma
Chipscreen Biosciences, Ltd.
 2022-08-25 PHASE2
NCT04921527 RECRUITING
Ovarian Cancer; Relapsed or Refractory; Chiauranib; Paclitaxel
Chipscreen Biosciences, Ltd.
 2021-12-20 PHASE3
NCT05336721 TERMINATED
Triple-negative Breast Cancer
Chipscreen Biosciences, Ltd.
 2021-11-05 PHASE2
NCT05505825 COMPLETED
SCLC,Extensive Stage
Akeso
 2022-08-26 PHASE1; PHASE2
NCT04830813 COMPLETED
Small Cell Lung Cancer
Chipscreen Biosciences, Ltd.
 2021-03-05 PHASE3
NCT05371899 COMPLETED
Small Cell Lung Cancer
Chipscreen Biosciences, Ltd.
 2022-07-20
NCT03216343 COMPLETED
Small Cell Lung Cancer
Chipscreen Biosciences, Ltd.
 2017-11-09 PHASE1
NCT05346601 COMPLETED
Healthy Volunteers
Chipscreen Biosciences, Ltd.
 2022-06-02 PHASE1
NCT05346601 Completed
Healthy Volunteers
Chipscreen Biosciences Ltd.|H & J CRO International Inc.
 2022-06-02 Phase 1
NCT03974243 COMPLETED
Non-hodgkin's Lymphoma
Chipscreen Biosciences, Ltd.
 2019-07-11 PHASE1; PHASE2
NCT03901118 COMPLETED
Ovarian Cancer
Chipscreen Biosciences, Ltd.
 2019-07-01 PHASE2
NCT03245190 COMPLETED
Hepatocellular Carcinoma
Chipscreen Biosciences, Ltd.
 2018-04-28 PHASE1; PHASE2
NCT03166891 COMPLETED
Ovarian Cancer
Chipscreen Biosciences, Ltd.
 2017-12-15 PHASE1; PHASE2
NCT03074825 TERMINATED
Non-Hodgkin's Lymphoma
Chipscreen Biosciences, Ltd.
 2017-05-09 PHASE1
NCT02122809 COMPLETED
Solid Tumors
Chipscreen Biosciences, Ltd.
 2014-02 PHASE1
NCT02122809 Completed
Solid Tumors
Chipscreen Biosciences Ltd.
 2014-02 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-03)

Check the Chiauranib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chiauranib selectively binds to and inhibits Aurora B kinase, colony-stimulating factor 1 receptor (CSF1R), and receptor tyrosine kinases including VEGFR, PDGFR, and c-Kit, thereby suppressing downstream oncogenic signaling cascades to block rapid tumor cell proliferation and impair angiogenesis while enhancing antitumor immunity. This multi-target inhibition disrupts both tumor cell survival and microenvironment maintenance, offering a mechanistic basis for its therapeutic investigation in clinical trials for advanced solid tumors, small cell lung cancer, 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>).

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