Clinical Trials

Multiple clinical trials spanning Early Phase 1 through Phase 3 have evaluated azeliragon (TTP488) across central nervous system disorders, oncology, metabolic disease, infectious conditions, and inflammatory pain, specifically targeting Alzheimer's disease, glioblastoma, pancreatic cancer, diabetic nephropathy, and COVID-19. Sponsored by pharmaceutical companies such as Pfizer, vTv Therapeutics, and Cantex Pharmaceuticals, alongside academic institutions like NYU Langone Health and City of Hope Medical Center, these studies encompass diverse recruitment statuses including completed, active, recruiting, terminated, withdrawn, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07694089 NOT_YET_RECRUITING
High-grade Gliomas (HGG)
Akshitkumar MIstry
 2026-10-01 PHASE2
NCT06831526 RECRUITING
Glioblastoma
Washington University School of Medicine
 2025-11-06 EARLY_PHASE1
NCT07785856 NOT_YET_RECRUITING
T-dxd Resistant HER2-Positive; HER2 Low Metastatic Breast Cancer
The Methodist Hospital Research Institute
 2026-12 PHASE1; PHASE2
NCT05789589 SUSPENDED
Cancer; Metastasis; Metastatic Cancer; Brain Metastases; Brain Metastases, Adult
Baptist Health South Florida
 2023-11-17 PHASE1; PHASE2
NCT06724926 ACTIVE_NOT_RECRUITING
Solid Tumor; High-grade Glioma; Leptomeningeal Metastasis
NYU Langone Health
 2025-02-18 PHASE1
NCT05256745 RECRUITING
Cancer Related Cognitive Decline; Non-metastatic Breast Cancer
Georgetown University
 2023-06-06 PHASE1; PHASE2
NCT05986851 ACTIVE_NOT_RECRUITING
Glioblastoma
Cantex Pharmaceuticals
 2023-09-12 PHASE2
NCT05635734 COMPLETED
Glioblastoma
Cantex Pharmaceuticals
 2023-09-05 PHASE1; PHASE2
NCT05815485 ACTIVE_NOT_RECRUITING
COVID-19
The University of Texas Medical Branch, Galveston
 2023-05-04 PHASE2; PHASE3
NCT07092215 COMPLETED
Pain
Stefan Heber
 2025-06-17 EARLY_PHASE1
NCT05766748 UNKNOWN
Metastatic Pancreatic Cancer
Cantex Pharmaceuticals
 2023-06-01 PHASE1; PHASE2
NCT05773664 WITHDRAWN
Glioblastoma; Malignant Glioma
City of Hope Medical Center
 2024-11-15 PHASE1
NCT03980730 TERMINATED
Alzheimer Disease
vTv Therapeutics
 2019-06-27 PHASE2
NCT02916056 TERMINATED
Alzheimer's Disease
vTv Therapeutics
 2016-12 PHASE3
NCT02080364 TERMINATED
Alzheimer's Disease
vTv Therapeutics
 2015-04 PHASE3
NCT00566397 COMPLETED
Alzheimer's Disease
Pfizer
 2007-12 PHASE2
NCT00287183 COMPLETED
Diabetic Nephropathy
Pfizer
 2006-02 PHASE2
NCT00287183 Completed
Diabetic Nephropathy
Pfizer
 2006-02 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-09)

Check the Azeliragon (TTP488) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Azeliragon is an orally bioavailable small-molecule antagonist that selectively binds to the receptor for advanced glycation endproducts (RAGE), thereby inhibiting ligand-induced receptor activation and downstream pro-inflammatory signaling pathways. By suppressing RAGE-mediated cellular injury and neuroinflammation, this targeted blockade reduces pathological signaling, providing therapeutic potential in studied conditions such as Alzheimer's disease, glioblastoma, and diabetic nephropathy.

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.