Drugs / Liafensine
Liafensine
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01396252 | Sep 2011 → May 2012 | depressive disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00892840 | May 2009 → Nov 2010 | depressive disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05113771 | Jun 2022 → Feb 2024 | — | Denovo Biopharma LLC | Completed | Met primary |
| Phase 2 | NCT01361555 | Aug 2011 → Oct 2013 | major depressive disorder | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT01369095 | Jul 2011 → May 2013 | depressive disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01309945 | Apr 2011 → Jan 2013 | depressive disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00964912 Comparator | Jul 2008 → Apr 2009 | depressive disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-09-11 | Denovo Biopharma LLC | Results A Landmark Pivotal Study ApplyingPrecision Medicine to Psychiatry with Denovo’s DB104 (liafensine) for Treatment-Resistant Depression Published in JAMA Psychiatry denovobiopharma.com ↗
The study demonstrated robust efficacy of DB104 (liafensine) in treatment-resistant depression (TRD) patients carrying a novel pharmacogenomic biomarker, ANK3. |
| 2024-10-09 | Denovo Biopharma LLC | Regulatory FDA Grants Fast Track Designation For Biomarker-Guided DB104 (liafensine) in Patients with Treatment-Resistant Depression (TRD) denovobiopharma.com ↗ |
| 2024-05-28 | Denovo Biopharma LLC | Results Denovo Biopharma LLC to Present Positive Phase 2b ENLIGHTEN Trial Data for DGM4 Biomarker-Guided DB104 (liafensine) Treatment for Treatment ‑Resistant Depression at the ASCP 2024 Annual Meeting denovobiopharma.com ↗
The trial met its primary and secondary endpoints and demonstrated the utility of Denovo's unique genetic biomarker discovery platform. |
| 2024-04-03 | Denovo Biopharma LLC | Results Denovo Biopharma Announces a Major Breakthrough in Treatment Resistant Depression with Precision Medicine denovobiopharma.com ↗
The primary endpoint was met: the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline for liafensine demonstrated a 4.4 point improvement over placebo (p = 0.0056). |
| 2021-11-02 | Denovo Biopharma LLC | Results Denovo Biopharma LLC Announces Multiple Presentations at Major Conferences denovobiopharma.com ↗
DGM4 did not predict efficacy in patients receiving standard of care treatments and as such was specific to liafensine. |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Liafensine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05113771 ↗ |
| Known as | BMS-820836 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00892840 ↗ |
| Known as | Liafensina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364614 ↗ |
| Action | Inhibit | “Liafensine, a triple reuptake inhibitor, may become a new precision medicine for treatment-resistant depression (TRD), a major unmet medical need.” PMID 40928787 ↗ Dec 2025 |
| Modality | Small molecule | — CHEMBL2364614 ↗ |
| Route | Oral | “Oral Solution, Oral” NCT00892840 ↗ |