Tenalisib Clinical Trials

Size	Price	Qty
2mg	USD 157
5mg	USD 270

Clinical Trials

Multiple Phase 1, Phase 1/2, and Phase 2 clinical trials sponsored primarily by Rhizen Pharmaceuticals SA and Incozen Therapeutics Pvt Ltd evaluate the therapeutic efficacy and safety of tenalisib as monotherapy and in combination regimens. These studies target various hematologic malignancies and solid tumors, including T-cell lymphoma, classical Hodgkin lymphoma, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and triple-negative or metastatic breast cancer. Ranging in status from completed and recruiting to terminated or withdrawn, these protocols highlight the ongoing clinical evaluation of tenalisib across diverse oncological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06189209	RECRUITING	Triple Negative Breast Cancer (TNBC)	Rhizen Pharmaceuticals SA	2024-03-04	PHASE2
NCT05239910	WITHDRAWN	Peripheral T Cell Lymphoma	Rhizen Pharmaceuticals SA	2023-01	PHASE2
NCT06189209	Recruiting	Triple Negative Breast Cancer (TNBC)	Rhizen Pharmaceuticals SA\|Incozen Therapeutics Pvt Ltd	2024-03-04	Phase 2
NCT05021900	COMPLETED	Locally Advanced Breast Cancer; Metastatic Breast Cancer	Rhizen Pharmaceuticals SA	2021-10-13	PHASE2
NCT03711604	COMPLETED	Hematological Malignancies	Rhizen Pharmaceuticals SA	2018-11-28	PHASE1; PHASE2
NCT03770000	COMPLETED	T Cell Lymphoma	Rhizen Pharmaceuticals SA	2019-03-12	PHASE1; PHASE2
NCT04204057	COMPLETED	Leukemia, Lymphocytic, Chronic, B-Cell	Rhizen Pharmaceuticals SA	2019-11-28	PHASE2
NCT03711578	COMPLETED	Non Hodgkin Lymphoma	Rhizen Pharmaceuticals SA	2018-11-25	PHASE2
NCT03770000	Completed	T Cell Lymphoma	Rhizen Pharmaceuticals SA	2019-03-12	Phase 1\|Phase 2
NCT03471351	TERMINATED	Classical Hodgkin Lymphoma	Rhizen Pharmaceuticals SA	2018-07-18	PHASE1
NCT03471351	Terminated	Classical Hodgkin Lymphoma	Rhizen Pharmaceuticals SA	2018-07-18	Phase 1
NCT02567656	Completed	Lymphoma T-Cell Peripheral\|Lymphoma T-Cell Cutaneous	Rhizen Pharmaceuticals SA	2015-09	Phase 1
NCT02017613	Completed	Lymphoma B-Cell\|T-Cell Lymphoma	Rhizen Pharmaceuticals SA	2013-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-12-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tenalisib functions as a potent and selective dual inhibitor of phosphoinositide 3-kinase delta (PI3Kδ) and gamma (PI3Kγ) isoforms, thereby blocking downstream PI3K/AKT signaling pathways essential for cellular survival and proliferation. By suppressing these enzymatic pathways, tenalisib induces apoptosis and inhibits tumor growth, providing therapeutic relevance in the treatment of T-cell lymphomas, Hodgkin lymphoma, and triple-negative breast cancer evaluated in clinical trials.

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>).