NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2022
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
VENLAFAXINE BESYLATE (venlafaxine) by Almatica Pharma is cns. First approved in 2022.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Venlafaxine Besylate is an oral extended-release tablet formulation of venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI) approved by the FDA in June 2022. It works by inhibiting neuronal reuptake of serotonin and norepinephrine in the CNS, with weak dopamine reuptake inhibition, making it suitable for depression and anxiety disorders. The besylate salt formulation represents a differentiated delivery approach in a mature SNRI market.
LOE Approaching1.9 years to LOE
Product is in late-stage lifecycle with LOE approaching in ~1.9 years, indicating smaller commercial teams and a focus on defensive market share strategies rather than growth expansion.
Mechanism of Action
CNS. Preclinical studies have shown that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets
Started May 2024
736 enrolled
Major Depressive Disorder
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
Started Jul 2023
555 enrolled
Generalized Anxiety Disorder
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
Started Jun 2020
605 enrolled
Major Depressive Disorder
Switching From SSRI to Desvenlafaxine on Cognitive Functioning
Started Apr 2018
36 enrolled
Major Depressive Disorder
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Started Nov 2017
59 enrolled
Hot FlashesBreast Neoplasms
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.