Talabostat (Val-boroPro, PT-100) Mesylate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Talabostat has been evaluated across numerous clinical trials spanning Phase 1 through Phase 3 for indications including non-small cell lung cancer, pancreatic adenocarcinoma, melanoma, chronic lymphocytic leukemia, and advanced solid neoplasms. Sponsored by industry and academic entities—such as Point Therapeutics, BioXcel Therapeutics, M.D. Anderson Cancer Center, and the National Institutes of Health—outcomes varied from completed Phase 2 trials to terminated Phase 3 studies. Overall, clinical development has focused on combining talabostat with standard chemotherapies or immunotherapies to treat refractory hematologic and solid tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04171219	TERMINATED	Advanced Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm	M.D. Anderson Cancer Center	2020-03-19	PHASE2
NCT04123574	WITHDRAWN	Cancer of Pancreas; Cancer of the Pancreas; Neoplasms, Pancreatic; Pancreas Cancer; Pancreatic Cancer	BioXcel Therapeutics Inc	2019-10-15	EARLY_PHASE1
NCT00489710	WITHDRAWN	Kidney Cancer	University of Nebraska	2006-12	PHASE2
NCT00243204	TERMINATED	Carcinoma, Non-Small Cell Lung	Point Therapeutics	2006-01	PHASE3
NCT00080080	COMPLETED	Lung Cancer	Point Therapeutics		PHASE2
NCT00290017	TERMINATED	Carcinoma, Non-Small-Cell Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary	Point Therapeutics	2006-02	PHASE3
NCT00086203	COMPLETED	Chronic Lymphocytic Leukemia	Point Therapeutics		PHASE2
NCT00116389	TERMINATED	Pancreatic Cancer; Neoplasm Metastasis; Adenocarcinoma	Point Therapeutics		PHASE2
NCT00083252	COMPLETED	Melanoma; Skin Cancer	Point Therapeutics		PHASE2
NCT00303940	COMPLETED	Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific	National Institutes of Health Clinical Center (CC)	2005-12	PHASE1
NCT00083239	COMPLETED	Melanoma; Skin Cancer	Point Therapeutics		PHASE2

(data from https://clinicaltrials.gov, updated on 2025-05-16)

Check the Talabostat (Val-boroPro, PT-100) Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Talabostat potently inhibits dipeptidyl peptidases, including DPP-IV, DPP8, DPP9, and fibroblast activation protein, blocking enzymatic peptide cleavage and triggering downstream pro-inflammatory cytokine production. This biological cascade stimulates hematopoiesis and enhances host immune responses within the tumor microenvironment, promoting tumor cell clearance in clinical trial conditions such as non-small cell lung cancer, pancreatic cancer, and melanoma.

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>).