Drugs / Azeliragon
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06831526 | Nov 2025 → Feb 2029 expected | glioblastoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 0 | NCT07092215 | Jun → Jul 2025 | — | Stefan Heber | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06724926 | Feb 2025 → Jan 2027 expected | high grade astrocytic tumor, neoplastic meningitis | NYU Langone Health | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05773664 | Nov 2024 | glioblastoma | City of Hope Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05789589 | Nov 2023 → Mar 2027 | metastatic malignant neoplasm in the brain | Baptist Health South Florida | Suspended | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05635734 | Sep 2023 → Apr 2026 | glioblastoma | Cantex Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT05256745 | Jun 2023 → Dec 2026 expected | breast cancer, subjective cognitive decline | Georgetown University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05766748 | Jun 2023 → Feb 2025 | malignant pancreatic neoplasm | Cantex Pharmaceuticals | Unknown | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07694089 | Oct 2026 → Aug 2029 expected | high grade astrocytic tumor | Akshitkumar MIstry | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05986851 | Sep 2023 → Sep 2026 overdue | glioblastoma | Cantex Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03980730 | Jun 2019 → Dec 2020 | Alzheimer disease | vTv Therapeutics | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT00566397 | Dec 2007 → Dec 2010 | Alzheimer disease | Pfizer | Completed | Met primary |
| Phase 2 | NCT00141661 | Oct 2005 → Jun 2006 | Alzheimer disease | Pfizer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05815485 | May 2023 → Apr 2026 overdue | COVID-19 | The University of Texas Medical Branch, Galveston | Active not recruiting | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT02916056 | Dec 2016 → Jun 2018 | Alzheimer disease | vTv Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT02080364 | Apr 2015 → Jun 2018 | Alzheimer disease | vTv Therapeutics | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00287183 Comparator | Feb 2006 → Aug 2009 | diabetic kidney disease | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2020-12-15 | vTv Therapeutics | Results vTv Therapeutics Announces Topline Results of Phase 2 Elevage Study of Azeliragon in Patients with Mild Alzheimer’s Disease and Type 2 Diabetes vtvtherapeutics.com ↗
The azeliragon treated group (n=21) had a 1.8 point decline from baseline in ADAS-cog14 compared to a placebo (n=22) decline of 0.35. |
| 2020-11-04 | vTv Therapeutics | Results vTv Therapeutics Presents Baseline Characteristics of the Enrolled Subjects in the Elevage Study Suggesting Comparability to the Post-Hoc Diabetes Subgroup of the Phase 3 STEADFAST Study vtvtherapeutics.com ↗
The data demonstrate that the patients enrolled in Elevage (n=43) have similar baseline characteristics to those in the STEADFAST A-study type 2 diabetes (T2D) subgroup (NCT02080364) (n=47). |
| 2019-03-28 | vTv Therapeutics | Results vTv Therapeutics to Present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases vtvtherapeutics.com ↗
The results support the hypothesis that treatment with azeliragon may improve cognition and/or preserve function in patients with type 2 diabetes and mild Alzheimer’s disease, showing favorable trends for less whole brain atrophy, less ventricular enlargement, and smaller decreases in glucose uptake in the azeliragon-treated subgroup compared to placebo. |
| 2018-10-24 | vTv Therapeutics | Results vTv Therapeutics Presents Positive Data on the Effect of Azeliragon in Patients with Alzheimer’s and Diabetes at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) Conference vtvtherapeutics.com ↗
The data presented at the conference included post-hoc, positive data indicating a potential benefit of treatment with azeliragon in AD patients with type 2 diabetes. |
| 2018-06-12 | vTv Therapeutics | Results vTv Therapeutics Announces Topline Results from Part B of Phase 3 STEADFAST Study vtvtherapeutics.com ↗
vTv Therapeutics Inc. (Nasdaq:VTVT) today announced that results from Part B of the Company’s STEADFAST Study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet co-primary efficacy endpoints. |
| 2018-05-09 | vTv Therapeutics | Results vTv Therapeutics Announces Company will Pre-specify New Subgroup with the FDA and Report Phase 3 Part B Results in June vtvtherapeutics.com ↗
This benefit was observed at 12 months. |
| 2018-04-09 | vTv Therapeutics | Results vTv Therapeutics Announces Topline Results from the First STEADFAST Phase 3 Study Evaluating Azeliragon in People with Mild Alzheimer’s Disease vtvtherapeutics.com ↗
vTv Therapeutics, Inc. (vTv) (Nasdaq:VTVT) today announced that results from Part A of the Company’s Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet either co-primary efficacy endpoint. |
| 2017-10-30 | vTv Therapeutics | Results vTv Therapeutics to Present on Azeliragon at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) vtvtherapeutics.com ↗
Analysis of treatment emergent adverse event incidences in phase 2 study of azeliragon reveal potential attenuation of psychiatric system organ class (SOC) adverse events and expected drug effects in gastrointestinal SOC |
| 2016-09-02 | vTv Therapeutics | Results vTv Therapeutics to Present at the International Psychogeriatric Association International Congress vtvtherapeutics.com ↗
The Phase 2b results of 5mg per day of azeliragon over a period of 18 months showed statistically significant benefit in mild-to-moderate Alzheimer’s patients (+3.1 points on ADAS-Cog11 standard measure of cognition) and greater benefit in mild patients (+4.0 points on ADAS-Cog11) |
| 2016-07-27 | vTv Therapeutics | Results vTv Therapeutics Announces Presentation of Phase 2b Azeliragon Results at the 2016 Alzheimer’s Association International Conference (AAIC) vtvtherapeutics.com ↗
Data presented show that azeliragon 5mg/day was effective in delaying the time to cognitive deterioration when compared to placebo in patients with mild Alzheimer’s disease. |
| 2014-07-10 | vTv Therapeutics | Regulatory TransTech Pharma, LLC Announces Agreement with FDA on Special Protocol Assessment for TTP488 Phase 3 Trial in Patients with Mild Alzheimer's Disease vtvtherapeutics.com ↗
TransTech Pharma, LLC today announced that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment (SPA) process, on the design of a single Phase 3 trial of TTP488 for the treatment of patients with mild Alzheimer’s disease. |
| 2013-03-18 | vTv Therapeutics | Regulatory FDA Grants TransTech Pharma Inc. Fast Track Designation for TTP488 for the Treatment of Alzheimer's Disease vtvtherapeutics.com ↗
High Point, North Carolina (March 18, 2013) TransTech Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for TTP488, a new small-molecule chemical compound being developed for the treatment of Alzheimer’s disease. |
| 2012-10-29 | vTv Therapeutics | Results Novel, Oral Drug TTP488 Shows Promise for Disease Modification in Alzheimer’s Patients vtvtherapeutics.com ↗
Analysis, by TransTech Pharma and third-party experts, of the study data reveals a 26% benefit relative to placebo in cognitive decline over 18 months in the group that received a 5 mg dose of TTP488. |
All press releases naming this drug 25 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azeliragon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05986851 ↗ |
| Known as | PF 04494700 | “A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants...” NCT00566397 ↗ |
| Known as | TTP448 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989929 ↗ |
| Known as | TTP488 | “A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants...” NCT00566397 ↗ |
| Action | Inhibit | “Moreover, these alterations can be reversed by the RAGE inhibitor, Azeliragon which is in a phase I/II clinical trial NCT05635734.” PMID 39744679 ↗ Jan 20251“Advanced glycosylation end product-specific receptor antagonist” CHEMBL3989929 ↗ |
| Modality | Small molecule | — CHEMBL3989929 ↗ |
| Route | Oral | “Orally-Administered PF-04494700” NCT00141661 ↗ |
| Target | AGER | “Advanced glycosylation end product-specific receptor antagonist” CHEMBL3989929 ↗ |