RALDESY
LOE Approachingtrazodone hydrochloride oral
NDAORALSOLUTION
Approved
Nov 2024
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
4/8 — Partial
RALDESY (trazodone hydrochloride oral) is 12. Approved for major depressive disorder (mdd) in adults ( ). First approved in 2024.
Drug data last refreshed 17h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RALDESY is a newly approved (November 2024) oral solution formulation of trazodone hydrochloride, a serotonergic antidepressant indicated for major depressive disorder in adults. It works as a selective serotonin reuptake inhibitor (SSRI) and 5HT2 receptor antagonist, enhancing serotonergic activity in the central nervous system. The mechanism of action's precise contribution to antidepressant efficacy remains incompletely understood.
LOE Approaching2.7 years to LOE
Recent launch in a mature therapeutic category with high competitive pressure (15 competitors) suggests a niche repositioning strategy; brand team focus will concentrate on formulation differentiation and rapid market capture before LOE in ~2.9 years.
Mechanism of Action
12.1 Mechanism of Action The mechanism of trazodone’s antidepressant action is unclear, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this…
Indications (1)
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.