Fetzima

(Levomilnacipran)

Phase 3Small molecule

AbbVie

Fetzima is one of 70 small molecule programs targeting Major Depressive Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Major Depressive DisorderActive, not recruiting

Smoking CessationActive, not recruiting

Major Depressive DisorderPhase 3

Active, not recruiting

Smoking CessationPreclinical

Active, not recruiting

Competition

Competitive Landscape

386 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Elavil

AstraZeneca

Phase 3

2 2

Ketalar

Boehringer Ingelheim

Phase 3

3 3

Psilocybin

COMPASS Pathways

Phase 3

11 4

Bupropion XL

GSK

Phase 3

1 5

SPD489

Takeda

Phase 3

3 6

Venlafaxine ER

Pfizer

Phase 3

2 7

Fetzima

AbbVie

Phase 3

9 8

MK0869, Aprepitant

Merck & Co.

Phase 3

4 9

Antidepressant Therapy

AbbVie

Phase 3

4 10

Saredutant

Sanofi

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Major Depressive Disorder9 trials

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT02431806·552 enrolled

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT01377194·568 enrolled

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

Completed·FForest Laboratories·Phase 2·NCT01254305·262 enrolled

Show 6 more trials

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT01034462·442 enrolled

Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT01085812·734 enrolled

A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

Completed·FForest Laboratories·Phase 4·NCT02288325·644 enrolled

Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

Completed· AbbVie logo

AbbVie·Phase 3·NCT03569475·501 enrolled

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT00969709·724 enrolled

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT00969150·362 enrolled

Smoking Cessation1 trial

Novel Medication as a Potential Smoking Cessation Aid

Completed·UUniversity of Minnesota·N/A·NCT02265367·56 enrolled

Depression1 trial

Trial of Levomilnacipran in Geriatric Depression

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02466958·29 enrolled

Adult1 trial

Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD

Completed·—·Phase 3·NCT02720198·60 enrolled

NAC1 trial

Levomilnacipran in Healthy Males

Unknown status·UUniversity of Ottawa·Phase 4·NCT03249311·36 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 25, 2013

FETZIMA

NDA NDA204168

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Levomilnacipran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levomilnacipran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Levomilnacipran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA204168). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fetzima. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Mar 2, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE43879Jan 11, 2026

8481598Mar 2, 2031

8865937May 23, 2032

Fetzima

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Major Depressive Disorder9 trials

Smoking Cessation1 trial

Depression1 trial

Adult1 trial

NAC1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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