Drugs / Levomilnacipran
Levomilnacipran
also known as
Levomilnacipran ER · F2695 · F2695 SR · (1s,2r)-milnacipran · (1s,2r)-milnacipran hydrochloride · F 2695 HYDROCHLORIDE · Fetzima · levomilnacipran extended release · +4 more
Small molecule targets SLC6A2, SLC6A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FETZIMA | — | 2019-10-07 – 2023-03-24 | fda.gov ↗ |
| Approved | US (FDA) | FETZIMA | — | 2013-07-25 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02266966 | Apr → Sep 2014 | — | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01254305 | Apr 2011 → Jul 2012 | major depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 39 trials · 3 met primary · 3 missed | ||||||
| Phase 3 | NCT07253207 | Oct 2024 → Jun 2025 | major depressive disorder | Zhejiang Huahai Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03569475 | Jul 2018 → Mar 2021 | major depressive disorder | Allergan | Completed | Missed primary |
| Phase 3 | NCT02431806 | Jun 2015 → Aug 2019 | major depressive disorder | Forest Laboratories | Completed | Missed primary |
| Phase 3 | NCT01639014 | Jul 2012 → Feb 2015 | ischemic stroke | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01377194 | Jun 2011 → Mar 2012 | major depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01085812 | Mar 2010 → Oct 2011 | major depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01034462 | Dec 2009 → Dec 2011 | major depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT00969150 | Sep 2009 → Nov 2010 | major depressive disorder | Forest Laboratories | Completed | Missed primary |
| Phase 3 | NCT00969709 | Sep 2009 → May 2011 | major depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03249311 | Mar 2018 → Dec 2019 | — | University of Ottawa | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02265367 | Jan 2015 → May 2017 | nicotine dependence | University of Minnesota | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT03321526 Background | Dec 2017 → Jun 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 3 | NCT02720198 Comparator | Jan 2017 → Jun 2018 | major depressive disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT03128021 Comparator | May 2017 → Jun 2023 | major depressive disorder | Howard Aizenstein | Completed | No outcome recorded |
| Phase 4 | NCT02466958 Comparator | Jun 2016 → Dec 2018 | major depressive disorder | University of California, Los Angeles | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-01-16 | Zydus Lifesciences Limited | Zydus receives tentative approval from the USFDA for Levomilnacipran Extended-Release Capsules zyduslife.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Levomilnacipran | “Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy” NCT03321526 ↗ |
| Known as | (1s,2r)-milnacipran | ChEMBL registry synonym — accepted as the source's own label CHEMBL99946 ↗ |
| Known as | (1s,2r)-milnacipran hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL99946 ↗ |
| Known as | F 2695 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL99946 ↗ |
| Known as | F2695 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02266966 ↗ |
| Known as | F2695 SR | “Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder” NCT00969150 ↗1“Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder” NCT01034462 ↗ |
| Known as | Fetzima | ChEMBL registry synonym — accepted as the source's own label CHEMBL99946 ↗ |
| Known as | Levomilnacipran ER | “Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks” NCT01254305 ↗3“Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.” NCT00969150 ↗ “Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks” NCT01377194 ↗ “Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.” NCT01034462 ↗ |
| Known as | levomilnacipran extended release | “patients with major depressive disorder (MDD) treated with levomilnacipran extended release (ER)” PMID 26644957 ↗ Jun 2015 |
| Known as | LEVOMILNACIPRAN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL99946 ↗ |
| Known as | Levomilnacipran Hydrochloride Extended-Release Capsules | “Levomilnacipran Hydrochloride Extended-Release Capsules 20mg/day is to be given orally, once daily, for 1-2 days in the first week of treatment.” NCT07253207 ↗ |
| Known as | Levomilnacipran SR | “Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder” NCT01377194 ↗ |
| Known as | LVM | “Levomilnacipran (LVM) is a novel antidepressant the effects of which on neuroplasticity have not yet been investigated.” PMID 31332902 ↗ Jul 2019 |
| Action | Inhibit | “Norepinephrine transporter inhibitor” CHEMBL99946 ↗2“Serotonin transporter inhibitor” CHEMBL99946 ↗ “reuptake inhibitor (SNRI)” PMID 27536449 ↗ Jan 2014 |
| Modality | Small molecule | — CHEMBL99946 ↗ |
| Route | Oral | “Study drug is to be given orally” NCT00969150 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter inhibitor” CHEMBL99946 ↗ |
| Target | SLC6A4 | “Serotonin transporter inhibitor” CHEMBL99946 ↗ |