Clinical Trials

Multiple early-phase clinical trials have evaluated bimiralisib (PQR309) across oncological and dermatological indications, including non-Hodgkin lymphoma, glioblastoma multiforme, metastatic breast cancer, head and neck squamous cell carcinoma, and actinic keratosis. Sponsored by industry entities such as PIQUR Therapeutics AG alongside academic institutions like M.D. Anderson Cancer Center and Mayo Clinic, these completed and terminated protocols evaluated dual PI3K/mTOR pathway inhibition. Overall, this research represents a comprehensive assessment of the compound across systemic, central nervous system, and hyperproliferative skin conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06319794 COMPLETED
Actinic Keratosis
TORQUR
 2024-04-02 PHASE2
NCT03740100 TERMINATED
HNSCC
M.D. Anderson Cancer Center
 2019-01-25 PHASE2
NCT02483858 COMPLETED
Cancer
PIQUR Therapeutics AG
 2019-03-21 PHASE1
NCT03127020 COMPLETED
Lymphoma; Non-Hodgkin Lymphoma
PIQUR Therapeutics AG
 2016-06 PHASE2
NCT02483858 Completed
Cancer
PIQUR Therapeutics AG|Roswell Park Cancer Institute|M.D. Anderson Cancer Center|Mayo Clinic|Hospital Clinic of Barcelona|University College London Hospitals|Churchill Hospital|Case Western Reserve University|University Hospital Zürich
 2019-03-21 Phase 1
NCT03120000 WITHDRAWN
Primary Central Nervous System Lymphoma
PIQUR Therapeutics AG
 2017-12 PHASE2
NCT02723877 COMPLETED
Metastatic Breast Cancer
PIQUR Therapeutics AG
 2016-03-28 PHASE1; PHASE2
NCT02249429 COMPLETED
Lymphoma, Malignant
PIQUR Therapeutics AG
 2015-05 PHASE2
NCT02669511 COMPLETED
Primary Central Nervous System Lymphoma
PIQUR Therapeutics AG
 2015-11-12 PHASE2
NCT02850744 TERMINATED
Glioblastoma Multiforme
PIQUR Therapeutics AG
 2015-07 PHASE2
NCT03127020 Completed
Lymphoma|Non-Hodgkin Lymphoma
PIQUR Therapeutics AG|University Hospital Basel Switzerland|University Hospital Munich|University Hospital Freiburg|Charite University Berlin Germany|University of Stuttgart
 2016-06 Phase 2
NCT02723877 Completed
Metastatic Breast Cancer
PIQUR Therapeutics AG|Hospital Universitario Ramon y Cajal|Hospital Universitari Vall d''Hebron Research Institute|Institut Català d''Oncologia|Churchill Hospital|Barts Cancer Institute|Fundación Instituto Valenciano de Oncología
 2016-03-28 Phase 1|Phase 2
NCT02850744 Terminated
Glioblastoma Multiforme
PIQUR Therapeutics AG|University Hospital Basel Switzerland|Insel Gruppe AG University Hospital Bern|University Hospital Zürich
 2015-07 Phase 2
NCT02249429 Completed
Lymphoma Malignant
PIQUR Therapeutics AG|University College London Hospitals|Churchill Hospital|Royal Marsden NHS Foundation Trust|University of Haifa|Weill Medical College of Cornell University|Institut Curie|University Clinical Center Sarajevo|Clinical Center Kragujevac|Clinical Center Nis Nis|Institute for Oncology and Radiology Serbia Belgrade|University Clinical Centre of Republic of Srpska
 2015-05 Phase 2
NCT01940133 COMPLETED
Advanced Solid Tumors
PIQUR Therapeutics AG
 2014-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-07-18)

Check the Bimiralisib (PQR309) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bimiralisib (PQR309) selectively binds to and inhibits phosphoinositide 3-kinase (PI3K) and mechanistic target of rapamycin (mTOR) catalytic subunits, blocking downstream phosphorylation cascades within the PI3K/AKT/mTOR signaling axis. This dual inhibition impairs cellular proliferation, metabolic survival, and tumor angiogenesis, resulting in significant antineoplastic activity against clinical trial targets such as lymphoma, glioblastoma multiforme, and advanced solid tumors.

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.