Tofranil

(imipramine)

ApprovedSmall molecule

Imipramine is used to treat depression and help control bedwetting in children. It works by changing the levels of certain chemicals in the brain that affect mood and can help strengthen bladder control.[2] Tofranil is currently approved and in use across 14 indications[4].[1]

Tofranil is one of 261 small molecule programs targeting Panic Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

260

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Panic DisorderActive, not recruiting

Depressive DisorderActive, not recruiting

Major Depressive DisorderActive, not recruiting

Somatoform DisorderApproved

Gastrointestinal DiseaseApproved

Gastroesophageal Reflux DiseaseApproved

Cutaneous PhotosensitivityApproved

EnuresisActive, not recruiting

Treatment Resistant DepressionActive, not recruiting

PolyneuropathyActive, not recruiting

Panic DisorderPreclinical

Active, not recruiting

Depressive DisorderApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

Somatoform DisorderApproved

Approved

Gastrointestinal DiseaseApproved

Approved

Gastroesophageal Reflux DiseaseApproved

Approved

Cutaneous PhotosensitivityApproved

Approved

EnuresisPreclinical

Active, not recruiting

Treatment Resistant DepressionPreclinical

Active, not recruiting

PolyneuropathyApproved

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Tofranil

Sanofi

Approved

25 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Sunosi

AAxsome Therapeutics, 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

Q1 2028

Phase 1Recruiting

Imipramine

NCT05688904

Q3 2028

PreclinicalRecruiting

Glioma

NCT07074756

Q4 2028

Phase 2Recruiting

Rosacea

NCT06312813

Q1 2029

Phase 2Recruiting

Immunosuppression

NCT06778434

Clinical

Trials by Indication[1]

Depression4 trials

Treatment of Depression Following Multiple Brain Tests

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00296777·28 enrolled

Comparing Various Treatments for Achieving and Maintaining Remission of Depression

Completed·UUniversity of Pittsburgh·Phase 4·NCT00227955·200 enrolled

Dichotic Listening as a Predictor of Medication Response in Depression

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00404755·17 enrolled

Show 1 more trial

Dichotic Listening as a Predictor of Medication Response in Depression

Completed·NNew York State Psychiatric Institute·Phase 1/2·NCT00296725·25 enrolled

Stress urinary incontinence2 trials

Therapeutic Efficacy in Women With Stress Urinary Incontinence

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT05677295·90 enrolled

Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Withdrawn·FFar Eastern Memorial Hospital·Phase 3·NCT04412876

Low back pain1 trial

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT01179828·150 enrolled

CAR1 trial

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

Completed·UUniversity of Utah·Phase 3·NCT00000518

Hypersensitivity1 trial

Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn

Completed·MMahidol University·Phase 3·NCT01753128·83 enrolled

16 more indications

Completed·BBirte Glenthoj·N/A·NCT00206999·20 enrolled

Enuresis1 trial

New Treatment for Nocturnal Enuresis in Children

Recruiting·SSohag University·N/A·NCT06497647·450 enrolled

Medication1 trial

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01028014·56 enrolled

Panic Disorder1 trial

Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder

Completed·NNorthwell Health·N/A·NCT00004834·326 enrolled

Polyneuropathy1 trial

Imipramine and Pregabalin Combination in Painful Polyneuropathy

Unknown status·OOdense University Hospital·Phase 4·NCT01047488·75 enrolled

Chest pain1 trial

Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00005575

Treatment Resistant Depression1 trial

Interpersonal Psychotherapy for Treatment Resistant Depression

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

Rosacea1 trial

Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Recruiting·WWright State University·Phase 2·NCT06312813·48 enrolled

Cardiac Arrest1 trial

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Completed·UUniversity of Washington·Phase 3·NCT00000464

Dyspepsia1 trial

The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia

Completed·—·Phase 3·NCT00164775·107 enrolled

Immunosuppression1 trial

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Recruiting·VVA Office of Research and Development·Phase 2·NCT06778434·48 enrolled

Imipramine1 trial

Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Recruiting·WWright State University·Phase 1·NCT05688904·24 enrolled

Glioma1 trial

MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol

Recruiting·MMayo Clinic·Preclinical·NCT07074756·202 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

TOFRANIL-PM

NDA NDA017090

Jan 1, 1982

TOFRANIL

NDA NDA011838

Jan 1, 1982

JANIMINE

NDA NDA017895

Jan 1, 1982

PRESAMINE

NDA NDA011836

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for imipramine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tofranil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — imipramine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for imipramine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017090). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

Tofranil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q3 2028

Q4 2028

Q1 2029

Trials by Indication[1]

Depression4 trials

Stress urinary incontinence2 trials

Low back pain1 trial

CAR1 trial

Hypersensitivity1 trial

Breast Cancer1 trial

Cardiac Arrhythmia1 trial

ESS1 trial

Enuresis1 trial

Medication1 trial

Panic Disorder1 trial

Polyneuropathy1 trial

Chest pain1 trial

Treatment Resistant Depression1 trial

Rosacea1 trial

Cardiac Arrest1 trial

Dyspepsia1 trial

Immunosuppression1 trial

Imipramine1 trial

Glioma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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