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 12 indications, with its most advanced program in Approved.[1]

Raldesy is one of 350 small molecule programs targeting Function. It is currently in Approved.

Indications

Total Trials

Active Trials

349

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

FunctionCompleted

Sexual DysfunctionActive, not recruiting

Depressive DisorderActive, not recruiting

Alzheimer DiseaseApproved

Obstructive Sleep ApneaApproved

Alcohol DependenceApproved

Sleep ApneaRecruiting

Treatment Resistant DepressionActive, not recruiting

Spinal Cord InjuryActive, not recruiting

Major Depressive DisorderCompleted

FunctionPreclinical

Completed

Sexual DysfunctionPreclinical

Active, not recruiting

Depressive DisorderApproved

Active, not recruiting

Alzheimer DiseaseApproved

Approved

Obstructive Sleep ApneaApproved

Approved

Alcohol DependenceApproved

Approved

Sleep ApneaApproved

Recruiting

Treatment Resistant DepressionPreclinical

Active, not recruiting

Spinal Cord InjuryApproved

Active, not recruiting

Major Depressive DisorderApproved

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Raldesy

PPragma

Approved

2 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 7

Psilocybin

COMPASS Pathways

Phase 3

11 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Aticaprant

Johnson & Johnson

Phase 3

4 10

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

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

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Obstructive Sleep Apnea

NCT05293600

Post-ApprovalNot yet recruiting

Delirium

NCT05085808

Q1 2027

ApprovedRecruiting

Sleep Apnea

NCT02922894

Q4 2027

Phase 2Recruiting

Insomnia

NCT06983080

Q2 2028

Phase 1Recruiting

Insomnia

NCT06281756

Phase 2Recruiting

Cognition

NCT05282550

Clinical

Trials by Indication[1]

Insomnia10 trials

Sequenced Therapies for Comorbid and Primary Insomnias

Completed·—·N/A·NCT01651442·211 enrolled

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Recruiting·MMilton S. Hershey Medical Center·Phase 1·NCT06281756·600 enrolled

National Adaptive Trial for PTSD Related Insomnia

Active, not recruiting·VVA Office of Research and Development·Phase 3·NCT03668041·673 enrolled

Show 7 more trials

CBT-I or Zolpidem/Trazodone for Insomnia

Completed·—·Phase 4·NCT04468776·155 enrolled

Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

Recruiting·—·Phase 2·NCT06983080·40 enrolled

Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans

Terminated·VVA Connecticut Healthcare System·Phase 4·NCT01662297·1 enrolled

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

Completed·UUniversity of Washington·Phase 3·NCT03534284·126 enrolled

Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia

Recruiting·—·N/A·NCT05125146·60 enrolled

Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Completed·MMilton S. Hershey Medical Center·N/A·NCT01348542·24 enrolled

Insomnia and Drug Relapse Risk

Completed·—·Phase 3·NCT00253890·137 enrolled

Sleep Apnea3 trials

The Effects of Trazodone on Sleep Apnea Severity

Completed·—·N/A·NCT01817907·15 enrolled

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

Completed·VVA Office of Research and Development·Phase 2·NCT02458469·15 enrolled

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

Recruiting·JJohn D. Dingell VA Medical Center·Approved·NCT02922894·100 enrolled

Delirium3 trials

Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium

Withdrawn·RRochester General Hospital·Phase 4·NCT02118688

RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)

Not yet recruiting·UUniversity of Southern California·Phase 4·NCT05085808·30 enrolled

Trazodone vs. Quetiapine for the Treatment of ICU Delirium

Recruiting·UUniversity of Southern California··NCT05307003·60 enrolled

Treatment Resistant Depression3 trials

Interpersonal Psychotherapy for Treatment Resistant Depression

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT01896349·74 enrolled

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

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03852160

Postpartum Depression2 trials

Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone

Withdrawn·VVerinder Sharma·Phase 1·NCT05299398

Quetiapine Versus Trazadone in Women With Postpartum Depression

Not yet recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 1·NCT06546358·50 enrolled

22 more indications

Major Depressive Disorder2 trials

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Unknown status·SShanghai Mental Health Center·Phase 4·NCT01764867·1,080 enrolled

Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.

Completed·EErich Seifritz·Phase 2·NCT04082806·54 enrolled

Obstructive Sleep Apnea2 trials

The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression

Completed·—·Phase 4·NCT04162743·22 enrolled

Treating Residual OSA With Endotype-directed Pharmacotherapy (Aim 3)

Recruiting·BBrigham and Women's Hospital·Preclinical·NCT05293600·70 enrolled

Morbidity1 trial

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Completed·UUniversity of Washington·N/A·NCT02655354·635 enrolled

Major Depression1 trial

Trazodone Once a Day in Major Depression Disorder

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A·Phase 3·NCT02086929·364 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

Tolerance1 trial

Trazodone Dose Tolerance and APAP Adherence

Suspended·—·Phase 1·NCT02945644·45 enrolled

Post-Traumatic Stress Disorder1 trial

Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder

Withdrawn·UUniversity of California, San Diego·Phase 1·NCT02699138

Menopause1 trial

Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

Recruiting·—·Phase 4·NCT07136415·1,000 enrolled

Sleep Disturbance1 trial

Trazodone for Sleep Disturbance in Early Alcohol Recovery

Completed·RRhode Island Hospital·Phase 2·NCT00027053·173 enrolled

Completed·—·Phase 3·NCT01142258·40 enrolled

Double-blind1 trial

A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

Completed·TTargeted Medical Pharma·Phase 3·NCT01468038·111 enrolled

Medication1 trial

Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations

Unknown status·UUniversity of Ottawa·Phase 1·NCT01400165·30 enrolled

Cognition1 trial

Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone

Recruiting·JJohns Hopkins University·Phase 2·NCT05282550·100 enrolled

Treatment1 trial

Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

Completed·—·Phase 4·NCT00659919·13 enrolled

MCI1 trial

Evaluation of Trazodone in OSA-MCI

Active, not recruiting·—·Phase 4·NCT05209035·134 enrolled

Agitation1 trial

Agitation in Alzheimer's Disease

Completed·NNational Institute on Aging (NIA)·Phase 3·NCT00000179

Depression1 trial

A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression

Completed·LLee's Pharmaceutical Limited·Phase 2/3·NCT01524497·382 enrolled

Function1 trial

Trazodone for SSRI-sexual Dsyfunction

Completed·—·N/A·NCT01097980·56 enrolled

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

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]
ClinicalTrials.gov — 45 trial records for Trazodone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trazodone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trazodone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218637). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Raldesy. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pragma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 2a (5-Ht2a) Receptor Antagonist; Serotonin 2c (5-Ht2c) Receptor Antagonist; Serotonin Transporter Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPragma

Patent Landscape[5]

Patent Cliff

Mar 27, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7829120Mar 27, 2027

8133893Mar 13, 2029

Raldesy

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Insomnia10 trials

Sleep Apnea3 trials

Delirium3 trials

Treatment Resistant Depression3 trials

Postpartum Depression2 trials

Major Depressive Disorder2 trials

Obstructive Sleep Apnea2 trials

Morbidity1 trial

Major Depression1 trial

Pain Management1 trial

Tolerance1 trial

Post-Traumatic Stress Disorder1 trial

Menopause1 trial

Sleep Disturbance1 trial

Oral1 trial

Diabetic Neuropathy1 trial

Sleep Disorder1 trial

Double-blind1 trial

Medication1 trial

Cognition1 trial

Treatment1 trial

MCI1 trial

Agitation1 trial

Depression1 trial

Function1 trial

Lactating Women on Select DOI1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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