3 active not recruiting, 3 completed, 3 terminated, 2 not yet recruiting. 10 Phase 2, 7 Phase 1, 3 Phase 3, 2 Early Phase 1.
Follow azeliragon: new trials by email Literature Review of azeliragon trials Research Report on azeliragon
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Trastuzumab Deruxtecan (T-DXd) in Combination With a RAGE Inhibitor in Patients With T-DXd-Resistant HER2-Positive or HER2-Low Metastatic Breast Cancer Azeliragon, T-DXd - T-dxd Resistant HER2-Positive, HER2 Low Metastatic Breast Cancer | Phase 1 / Phase 2 | Not yet recruiting | The Methodist Hospital Research Institute | 27 | 2026-12-01 | 2026-08-25 |
| Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas Dexamethasone, Azeliragon - High-grade Gliomas (HGG) | Phase 2 | Not yet recruiting | Akshitkumar MIstry | 80 | 2026-10-01 | 2026-07-09 |
| Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma Azeliragon, Temozolomide, Radiation therapy - Glioblastoma | Early Phase 1 | Recruiting | Washington University School of Medicine | 12 | 2025-11-06 | 2026-05-29 |
| Mechanisms of Pain Hypersensitivity in a Human Skin Inflammation Model Synthetic interstitial fluid (SIF) / SIF neutral pH, Synthetic interstitial fluid (SIF) / SIF acidic pH, Synthetic interstitial fluid (SIF) / SIF acidic pH + BCTC 1 µM - Pain | Early Phase 1 | Completed | Stefan Heber | 42 | 2025-06-17 | 2025-07-29 |
| Concurrent Azeliragon With Craniospinal Irradiation Azeliragon, CSI - Solid Tumor, High-grade Glioma | Phase 1 | Active not recruiting | NYU Langone Health | 21 | 2025-02-18 | 2026-05-18 |
| Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma Azeliragon, Biospecimen Collection, Computed Tomography - Glioblastoma, Malignant Glioma | Phase 1 | Withdrawn | City of Hope Medical Center | 2024-11-15 | 2024-09-19 | |
| Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases Azeliragon, Stereotactic radiosurgery, Corticosteroid - Cancer, Metastasis | Phase 1 / Phase 2 | Suspended | Baptist Health South Florida | 46 | 2023-11-17 | 2026-06-16 |
| Azeliragon in MGMT Unmethylated Glioblastoma Azeliragon - Glioblastoma | Phase 2 | Active not recruiting | Cantex Pharmaceuticals | 30 | 2023-09-12 | 2026-03-31 |
| Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Azeliragon 5 mg, Azeliragon 10 mg, Azeliragon 20 mg - Glioblastoma | Phase 1 / Phase 2 | Completed | Cantex Pharmaceuticals | 33 | 2023-09-05 | 2026-10-19 |
| RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer TTP488, ddAC/ddT, TC - Cancer Related Cognitive Decline, Non-metastatic Breast Cancer | Phase 1 / Phase 2 | Recruiting | Georgetown University | 48 | 2023-06-06 | 2025-12-24 |
| Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer Azeliragon - Metastatic Pancreatic Cancer | Phase 1 / Phase 2 | Unknown | Cantex Pharmaceuticals | 30 | 2023-06-01 | 2024-06-14 |
| A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Determine the Safety and Effectiveness of Azeliragon in the Treatment of Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) or Pneumonia Azeliragon, Placebo - COVID-19 | Phase 2 / Phase 3 | Active not recruiting | The University of Texas Medical Branch, Galveston | 144 | 2023-05-04 | 2025-03-03 |
| Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance Azeliragon, Placebo - Alzheimer Disease | Phase 2 | Terminated | vTv Therapeutics | 43 | 2019-06-27 | 2022-01-21 |
| 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) Azeliragon 5mg - Alzheimer's Disease | Phase 3 | Terminated | vTv Therapeutics | 297 | 2016-12-01 | 2021-06-01 |
| Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease Azeliragon, Placebo - Alzheimer's Disease | Phase 3 | Terminated | vTv Therapeutics | 880 | 2015-04-01 | 2021-05-07 |
| 6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria PF-04494700 (TTP488), Placebo - Diabetic Nephropathy | Phase 2 | Completed | Pfizer | 110 | 2006-02-01 | 2009-10-01 |
Glioblastoma (4) · Alzheimer Disease (3) · Glioma (2) · Acute Kidney Injury (1) · Brain Neoplasms (1) · COVID-19 (1) · Diabetic Nephropathies (1) · Hyperalgesia (1) · Inflammation (1) · Meningeal Carcinomatosis (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Pain (1) · Pancreatic Neoplasms (1)
Cantex Pharmaceuticals (3) · vTv Therapeutics (3) · Akshitkumar MIstry (1) · Baptist Health South Florida (1) · City of Hope Medical Center (1) · Georgetown University (1) · NYU Langone Health (1) · Pfizer (1) · Stefan Heber (1) · The Methodist Hospital Research Institute (1) · The University of Texas Medical Branch, Galveston (1) · Washington University School of Medicine (1)
United States (11) · Canada (4) · Australia (1) · Austria (1) · Ireland (1) · New Zealand (1) · South Africa (1) · Spain (1) · United Kingdom (1)
Aaron H Burstein, PharmD (1) · Akshitkumar M Mistry, MD (1) · Andrew Hendifar, MD (1) · Ann Gooch, Ph.D. (1) · Candace Mainor, MD (1) · Jana L Portnow (1) · Jiayi Huang, M.D. (1) · Jonathan Yang, MD, PhD (1) · Lucas S. Blanton, MD (1) · Minesh Mehta, M.D. (1) · Stephen G Marcus, MD (1)
PMID 10191237, PMID 18299127, PMID 20562702, PMID 21270403, PMID 28062311, PMID 30782041, PMID 32107360, PMID 33548580, PMID 33863932, PMID 34293819, PMID 34935141, PMID 39744679, PMID 41805697, PMID 42830319, PMID 5781321
P30CA033572 (1), U19CA264512 (1)