Norpramin

(Desipramine)

ApprovedSmall molecule

Desipramine is used to treat depression by helping to balance certain chemicals in the brain. It can also be used to treat anxiety and chronic pain conditions.[2] Norpramin is currently approved and in use across 17 indications[4].[1]

Norpramin is one of 465 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

464

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderActive, not recruiting

Erectile DysfunctionApproved

Cocaine AbuseActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Rett SyndromeApproved

Vulvar DiseaseActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

Substance-Related DisorderApproved

Cocaine DependenceApproved

Chronic PainActive, not recruiting

Depressive DisorderApproved

Active, not recruiting

Erectile DysfunctionApproved

Approved

Cocaine AbusePhase 2

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Rett SyndromeApproved

Approved

Vulvar DiseasePreclinical

Active, not recruiting

Obstructive Sleep ApneaPhase 2

Active, not recruiting

Substance-Related DisorderApproved

Approved

Cocaine DependenceApproved

Approved

Chronic PainApproved

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

386 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Norpramin

VValidus Pharmaceuticals

Approved

27 2

Nuplazid

AACADIA Pharmaceuticals Inc.

Phase 3

4 3

SAGE-217

Biogen

Phase 3

7 4

Celebrex

PPhiladelphia Eye Associates

Phase 3

2 5

Risperdal

WWim Janssens

Phase 3

2 6

Desvenlafaxine SR

Pfizer

Phase 3

13 7

SPD489

Takeda

Phase 3

3 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Rapastinel

DVS-233

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

Clinical

Trials by Indication[1]

Tics3 trials

Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00366652·20 enrolled

Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects

Completed·VVIVUS LLC·Phase 1·NCT01415128·60 enrolled

Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00329147·20 enrolled

Cocaine Abuse3 trials

IV Cocaine Abuse: A Laboratory Model - 1

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00000212

New Approaches to Cocaine Abuse Medications (A) - 6

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00000271·111 enrolled

Evaluation of a Desipramine Ceiling in Cocaine Abuse - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000245

Interaction2 trials

Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

Completed· Pfizer logo

Pfizer·Phase 1·NCT00500721·22 enrolled

A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01358968·20 enrolled

Depression2 trials

Biological Aspects of Depression and Antidepressant Drugs

Completed·UUS Department of Veterans Affairs·N/A·NCT00018733

Naltrexone & SSRI in Alcoholics With Depression/PTSD

Completed·YYale University·Phase 3·NCT00338962·88 enrolled

Platelet Function1 trial

Depression, Epinephrine, and Platelet Function

Completed·EEmory University·Phase 4·NCT00166114·40 enrolled

15 more indications

Back pain1 trial

Effect of Antidepressants on Back Pain

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018200·130 enrolled

Postherpetic Neuralgia1 trial

Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004390·120 enrolled

Methamphetamine Abuse1 trial

Methamphetamine Abuse Treatment in Patients With AIDS - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00000321

Irritable Bowel Syndrome1 trial

Irritable Bowel Syndrome (IBS) Functional Magnetic Resonance Imaging (fMRI) With Desipramine

Terminated·WWashington University School of Medicine·N/A·NCT00880594·18 enrolled

Randomized1 trial

A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

Completed·VVA Office of Research and Development·Phase 3·NCT01265550·366 enrolled

Chronic pain1 trial

Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Completed·SStanford University·Phase 4·NCT03548454·86 enrolled

Obstructive Sleep Apnea1 trial

Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B

Completed·—·Phase 2·NCT02436031·16 enrolled

Gastric Emptying1 trial

Tricyclic Antidepressants (TCAs) on Gastric Emptying

Terminated·TTemple University·N/A·NCT00220844·10 enrolled

Major Depression1 trial

Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

Completed·HHarvard Medical School (HMS and HSDM)·Phase 4·NCT00320632·43 enrolled

Treatment1 trial

Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

Completed·NNew York State Psychiatric Institute·N/A·NCT00456014·37 enrolled

Drug Therapy1 trial

Cognitive and Drug Therapy for Drug-Resistant Depression

Completed·UUniversity of Pennsylvania·N/A·NCT00000376

Adult1 trial

Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A

Completed·—·Phase 2·NCT02428478·17 enrolled

Functional Bowel Disorder1 trial

Treatment of Functional Bowel Disorders

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00006157·300 enrolled

Infusion1 trial

Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02273466·24 enrolled

Unspecified2 trials

Desipramine in Infantile Neuroaxonal Dystrophy (INAD).

Terminated·—·Phase 4·NCT03726996·4 enrolled

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

Completed· Astellas logo

Astellas·Phase 1·NCT01478568·28 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PERTOFRANE

NDA NDA013621

Feb 11, 1982

NORPRAMIN

NDA NDA014399

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Desipramine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Norpramin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Desipramine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Desipramine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA014399). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Validus Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VValidus Pharmaceuticals

Norpramin

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Tics3 trials

Cocaine Abuse3 trials

Interaction2 trials

Depression2 trials

Platelet Function1 trial

Back pain1 trial

Postherpetic Neuralgia1 trial

Methamphetamine Abuse1 trial

Irritable Bowel Syndrome1 trial

Randomized1 trial

Chronic pain1 trial

Obstructive Sleep Apnea1 trial

Gastric Emptying1 trial

Major Depression1 trial

Treatment1 trial

Drug Therapy1 trial

Adult1 trial

Functional Bowel Disorder1 trial

Infusion1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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