Drugs / Zelquistinel
Zelquistinel
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04981561 | Dec 2016 → Dec 2017 | major depressive disorder | Syndeio Biosciences, Inc | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT03726658 | Nov 2018 → Oct 2019 | major depressive disorder | Syndeio Biosciences, Inc | Completed | Missed primary |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT07115329 | Jan 2026 → Mar 2028 expected | major depressive disorder | Syndeio Biosciences, Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT06547489 | Feb 2025 → Sep 2027 expected | major depressive disorder | Syndeio Biosciences, Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT03586427 | Jun 2018 → Jul 2019 | major depressive disorder | Syndeio Biosciences, Inc | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07099989 Comparator | Jul 2025 → Feb 2026 overdue | — | Syndeio Biosciences, Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-12-12 | Syndeio Biosciences, Inc | Results Gate Neurosciences Presents New Data and Insights Highlighting Unique Pharmacology of Synaptic Function Modulators at the 2024 ACNP Annual Meeting syndeio.bio ↗
The two ACNP presentations detailed new insights on the pharmacology of molecules that enhance synaptic function and neuroplasticity, including both ketamine and Gate’s lead program, zelquistinel ( |
| 2018-07-23 | AbbVie | Regulatory Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD) abbvie.com ↗
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-12 | Syndeio Biosciences, Inc | Gate Neurosciences Presents New Data and Insights Highlighting Unique Pharmacology of Synaptic Function Modulators at the 2024 ACNP Annual Meeting syndeio.bio ↗ |
| 2018-07-23 | AbbVie | Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD) abbvie.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zelquistinel | “The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of zelquistinel (AGN-241751) compared with placebo in participants with Major Depressive...” NCT03586427 ↗ |
| Known as | AGN-241751 | “The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of zelquistinel (AGN-241751) compared with placebo in participants with Major Depressive...” NCT03586427 ↗ |
| Known as | GATE251 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314944 ↗ |
| Action | Activate | “positive allosteric modulator of the N-Methyl-D-Aspartate (NMDA) receptor” NCT07115329 ↗ |
| Modality | Small molecule | — CHEMBL5314944 ↗ |
| Route | Oral | “AGN-241751, oral administration, once per day in Part A. Twice per day (BID) in Part B” NCT03726658 ↗ |