Drugs / PQ912
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02190708 | Jun 2014 | — | Vivoryon Therapeutics N.V. | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT03919162 | Nov 2021 → Jul 2024 | Alzheimer disease | Vivoryon Therapeutics N.V. | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT04498650 | Jul 2020 → Dec 2023 | Alzheimer disease | Vivoryon Therapeutics N.V. | Completed | No outcome recorded |
| Phase 2 | NCT02389413 | Mar 2015 → Apr 2017 | Alzheimer disease | Vivoryon Therapeutics N.V. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-02-19 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Shares Highlights from Virtual R&D Update with KOL Speakers vivoryon.com ↗
Overall, Vivoryon is poised to improve kidney health with varoglutamstat’s novel mechanism of action and breakthrough clinical study results |
| 2025-01-14 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Provides R&D-Update Further Strengthening Development Pipeline in Kidney Disease vivoryon.com ↗
A meta-analysis of VIVIAD and VIVA-MIND 1 data confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR 2 kidney function in the overall study population |
| 2024-12-09 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Presents Topline Phase 2 Data fromVIVA-MIND Strongly Supporting Varoglutamstat’s Potential toImprove Kidney Function vivoryon.com ↗
Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced positive Phase 2 topline data from its U.S. VIVA-MIND study of varoglutamstat (PQ912), an investigational oral glutaminyl cyclase (QPCT/L) inhibitor, in early AD. |
| 2024-10-26 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Presents Outstanding Phase 2b Results of Varoglutamstat on Kidney Function at ASN Kidney Week 2024 vivoryon.com ↗
Results presented show a statistically significant and clinically meaningful improvement of the prospectively defined kidney function parameter eGFR 1 by 3.4mL/min/year (p<0.001) in the varoglutamstat arm compared to placebo |
| 2024-07-18 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Announces New Data Showing Unique Treatment Effects of Varoglutamstat on Kidney Function in Patients with Diabetes and Outlines Proposed Clinical Development Plan in Diabetic Kidney Disease vivoryon.com ↗
New data confirm beneficial treatment effect of varoglutamstat on kidney function |
| 2024-03-04 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Provides Update on VIVIAD Phase 2b Study of Varoglutamstat in Early Alzheimer’s Disease vivoryon.com ↗ |
| 2022-07-31 | Vivoryon Therapeutics N.V. | Results Vivoryon Therapeutics N.V. Presents Key Phase 2b Data at AAIC 2022 Showing that Varoglutamstat is Well Tolerated at Doses with High Target Inhibition, Highlighting Unique Opportunity in AD vivoryon.com ↗ |
| 2022-02-28 | Vivoryon Therapeutics N.V. | Regulatory Vivoryon Therapeutics and Simcere Announce CDE Approval of Chinese Clinical Trial Application for Varoglutamstat (SIM0408, PQ912) in Patients with Alzheimer’s Disease vivoryon.com ↗
We are proud to have obtained CDE approval of our Clinical Trial Application of varoglutamstat which represents our strong commitment in the battle against Alzheimer’s disease, |
| 2022-02-28 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere and Vivoryon Therapeutics Announce CDE Approval of Chinese Clinical Trial Application for Varoglutamstat (SIM0408, PQ912) in Patients with Alzheimer’s Disease simcere.com ↗
China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat (SIM0408, PQ912), a medicine in development for the treatment of Alzheimer’s disease (AD) developed in Greater China by Simcere. |
| 2021-12-23 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory FDA Fast Track Designation granted for Varoglutamstat in Early Alzheimer’s disease simcere.com ↗
Simcere Pharmaceutical Group Limited (HKEX: 2096) announced today that varoglutamstat (PQ912，SIM0408), an investigational oral small molecule medicine co-developed by Simcere and Vivoryon Therapeutics N.V. in Greater China for the potential treatment of early Alzheimer’s disease (AD) has obtained the U.S. Food and Drug Administration (FDA) Fast Track designation. |
| 2021-12-22 | Vivoryon Therapeutics N.V. | Regulatory Vivoryon Therapeutics Receives FDA Fast Track Designation for Varoglutamstat in Early Alzheimer’s Disease vivoryon.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for varoglutamstat (PQ912), an investigational oral small molecule medicine for the potential treatment of early Alzheimer’s disease (AD). |
| 2021-12-14 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory The Clinical Trial Application of Alzheimer's Disease Drug Varoglutamstat Accepted for Review by China CDE simcere.com ↗
Simcere Pharmaceutical Group Limited (HKEX: 2096) announced that the clinical trial application for SIM0408 (Varoglutamstat), a drug for the treatment of Alzheimer's disease (AD) co-developed with Vivoryon Therapeutics N.V., has been accepted for review by China CDE. |
| 2020-08-04 | Vivoryon Therapeutics N.V. | Regulatory Vivoryon Receives IND Approval for Varoglutamstat‘s (PQ912) Phase 2 Study in Alzheimer’s Disease vivoryon.com ↗
Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for varoglutamstat (PQ912). |
| 2020-06-26 | Vivoryon Therapeutics N.V. | Regulatory Vivoryon Therapeutics Provides Update on US and EU Alzheimer’s Clinical Trial Program with PQ912 vivoryon.com ↗
In addition, Vivoryon’s lead candidate, PQ912, received the approval of the International Nonproprietary Name (INN), varoglutamstat. |
| 2018-10-16 | Vivoryon Therapeutics N.V. | Results Probiodrug publishes SAPHIR data in peer reviewed journal vivoryon.com ↗ |
| 2017-06-11 | Vivoryon Therapeutics N.V. | Results Probiodrug announces encouraging results of the Phase 2a SAPHIR Study vivoryon.com ↗
today announced first line results of its Phase 2a SAPHIR study in early AD patients. |
| 2017-04-10 | Vivoryon Therapeutics N.V. | Results Probiodrug to present at Huntington’s Disease Therapeutics Conference vivoryon.com ↗
The QC inhibitor PQ912 clearly improved several signs of the disease in a well characterized BACHD mouse model of HD. |
| 2017-03-28 | Vivoryon Therapeutics N.V. | Results Probiodrug to present at Alzheimer’s and Parkinson’s Diseases Congress vivoryon.com ↗
Based on PKPD analysis in animal studies, a 50% inhibition of QC activity in the brain leads to a robust effect – an important translational guidance for therapeutic dosing in clinical studies |
All press releases naming this drug 22 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PQ912 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04498650 ↗ |
| Action | Inhibit | “PQ912 inhibits several CYP enzymes” NCT02190708 ↗ |
| Modality | Small molecule | “a first-in-class, new small molecule treatment for early Alzheimer's disease (AD)” NCT03919162 ↗ |
| Route | Oral | “from day2 up to day6 twice daily oral dose of PQ912” NCT02190708 ↗ |
| Target | CYP2C19 | “PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19” NCT02190708 ↗ |
| Target | CYP3A4 | “PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19” NCT02190708 ↗ |