Raldesy
(Trazodone)ApprovedSmall molecule
Raldesy is a small molecule that works as a Serotonin 2a (5-Ht2a) Receptor Antagonist; Serotonin 2c (5-Ht2c) Receptor Antagonist; Serotonin Transporter Inhibitor.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]
Raldesy is one of 471 small molecule programs targeting Depressive Disorder. It is currently in Approved.
17
Indications
45
Total Trials
14
Active Trials
470
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 16 indications
Competition
Competitive Landscape
386 competitors in Major Depressive Disorder
#DrugCompanyPhaseTrials
1Raldesy
PPragma
Approved
Quetiapine XR
AstraZenecaPhase 3
Clozaril
LLife Extension Foundation Inc.
Phase 3
Bupropion XL
GSKPhase 3
Esketamine Hydrochloride
TThe Second Hospital of Anhui Medical University
Phase 3
DVS-233
PfizerPhase 3
AXS-05
AAxsome Therapeutics, Inc.
Phase 3
Minocyclin
UUniversity of Southern California
Phase 3
NMRA-335140
NNeumora Therapeutics, Inc.
Phase 3
AGO178
NovartisPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Insomnia10 trials
Insomnia and Drug Relapse Risk
Completed·—·Phase 3·NCT00253890·137 enrolled
Show 7 more trials
Sequenced Therapies for Comorbid and Primary Insomnias
Completed·—·N/A·NCT01651442·211 enrolled
Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Recruiting·—·Phase 2·NCT06983080·40 enrolled
Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia
Recruiting·—·N/A·NCT05125146·60 enrolled
CBT-I or Zolpidem/Trazodone for Insomnia
Completed·—·Phase 4·NCT04468776·155 enrolled
Sleep Apnea3 trials
Delirium3 trials
Treatment Resistant Depression3 trials
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
Not yet recruiting·—·Phase 2·NCT07210112·112 enrolled
23 more indications
Postpartum Depression2 trials
Menopause1 trial
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Recruiting·—·Phase 4·NCT07136415·1,000 enrolled
Sleep Disorder1 trial
Trazodone for Sleep Disorders in Alzheimer's Disease
Completed·—·Phase 3·NCT01142258·40 enrolled
Tolerance1 trial
Trazodone Dose Tolerance and APAP Adherence
Suspended·—·Phase 1·NCT02945644·45 enrolled
Infants1 trial
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Recruiting·—··NCT03511118·1,600 enrolled
Medication1 trial
OSA1 trial
Rescue Pharmacotherapy for OSA
Recruiting·—·Phase 1/2·NCT05293600·70 enrolled
Pain Management1 trial
Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient
Terminated·—·Phase 4·NCT03522207·3 enrolled
Oral1 trial
MCI1 trial
Evaluation of Trazodone in OSA-MCI
Active, not recruiting·—·Phase 4·NCT05209035·134 enrolled
Treatment1 trial
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Completed·—·Phase 4·NCT00659919·13 enrolled
Obstructive Sleep Apnea1 trial
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
Completed·—·Phase 4·NCT04162743·22 enrolled
Function1 trial
Trazodone for SSRI-sexual Dsyfunction
Completed·—·N/A·NCT01097980·56 enrolled
Depression1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[4]
Jan 1, 1982
DESYREL
NDA NDA018207
Feb 2, 2010
OLEPTRO
NDA NDA022411
Nov 26, 2024
RALDESY
NDA NDA218637
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Trazodone. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
- [6]