LB-100 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Numerous clinical trials are evaluating LB-100, both as monotherapy and combined with chemotherapy or immunotherapy, across Phase 1, Phase 1/2, and Phase 2 studies. These trials investigate indications such as glioblastoma, myelodysplastic syndromes, extensive-stage small cell lung carcinoma, metastatic colorectal cancer, and advanced soft-tissue sarcoma, with recruitment statuses encompassing completed, actively recruiting, active non-recruiting, and not yet recruiting. Sponsorship is divided between Lixte Biotechnology Holdings and academic institutions including the National Cancer Institute, City of Hope Medical Center, and The Netherlands Cancer Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06012734	RECRUITING	Metastatic Microsatellite-stable Colorectal Cancer	The Netherlands Cancer Institute	2024-06-18	PHASE1
NCT06065462	RECRUITING	Ovarian Clear Cell Carcinoma	M.D. Anderson Cancer Center	2023-11-10	PHASE1; PHASE2
NCT04560972	ACTIVE_NOT_RECRUITING	Extensive Stage Lung Small Cell Carcinoma	City of Hope Medical Center	2021-05-28	PHASE1
NCT05809830	ACTIVE_NOT_RECRUITING	Advanced Soft-tissue Sarcoma	Grupo Espanol de Investigacion en Sarcomas	2023-05-29	PHASE1; PHASE2
NCT06012734	Not yet recruiting	Metastatic Microsatellite-stable Colorectal Cancer	The Netherlands Cancer Institute	2023-12	Phase 1
NCT03027388	COMPLETED	Astrocytoma, Grades II, III and IV; Glioblastoma Multiforme; Giant Cell Glioblastoma; Glioma; Oligodendrogliomas	National Cancer Institute (NCI)	2019-01-09	PHASE2
NCT03886662	RECRUITING	Myelodysplastic Syndromes	Lixte Biotechnology Holdings, Inc.	2019-04	PHASE1; PHASE2
NCT03886662	Unknown status	Myelodysplastic Syndromes	Lixte Biotechnology Holdings Inc.	2019-04	Phase 1\|Phase 2
NCT03027388	Completed	Astrocytoma Grades II III and IV\|Glioblastoma Multiforme\|Giant Cell Glioblastoma\|Glioma\|Oligodendrogliomas	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2019-01-09	Phase 2
NCT01837667	COMPLETED	Tumors; Neoplasms; Cancer	Lixte Biotechnology Holdings, Inc.	2013-02	PHASE1
NCT01837667	Completed	Tumors\|Neoplasms\|Cancer	Lixte Biotechnology Holdings Inc.	2013-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the LB-100 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LB-100 functions as a potent inhibitor of protein phosphatase 2A (PP2A), blocking the enzymatic dephosphorylation of key signaling cascades to induce hyperphosphorylation and persistent activation of pro-apoptotic cellular pathways. This accumulation of phosphoproteins causes cell cycle arrest, DNA repair impairment, and cell death, providing the biological foundation for its clinical trial evaluation in solid tumors, glioblastoma, and small cell lung carcinoma.

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>).