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 20h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RALDESY is an oral solution formulation of trazodone hydrochloride approved in November 2024 for major depressive disorder in adults. It works through dual mechanisms: selective serotonin reuptake inhibition and 5-HT2 receptor antagonism, though the exact contribution of each to its antidepressant effect remains unclear. The formulation offers no clinically significant pharmacokinetic advantage over immediate-release tablets under fed conditions.
LOE Approaching2.4 years to LOE
Recently approved product faces rapid LOE in 2.4 years, limiting growth runway and suggesting lean, focused commercial teams rather than expansion-stage hiring.
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.