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 16 indications[4].[1]

Norpramin is one of 357 small molecule programs targeting Vulvar Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

356

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Vulvar DiseaseActive, not recruiting

Depressive DisorderActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Major Depressive DisorderActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

Gastroesophageal Reflux DiseaseApproved

Post-Traumatic Stress DisorderApproved

Substance-Related DisorderApproved

Erectile DysfunctionApproved

Rett SyndromeApproved

Vulvar DiseasePreclinical

Active, not recruiting

Depressive DisorderApproved

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

Irritable Bowel SyndromePreclinical

Active, not recruiting

Gastroesophageal Reflux DiseaseApproved

Approved

Post-Traumatic Stress DisorderApproved

Approved

Substance-Related DisorderApproved

Approved

Erectile DysfunctionApproved

Approved

Rett SyndromeApproved

Approved

Showing 10 of 16 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Norpramin

VValidus Pharmaceuticals

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Minipress

Pfizer

Preclinical

1 6

Emtriva

Gilead

Preclinical

1 7

Valium

Akero Therapeutics

Preclinical

2 8

Lotemax

PPharmos

Preclinical

1 9

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 10

Intuniv

PPromius Pharma, LLC

Preclinical

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

Clinical

Trials by Indication[1]

Tics3 trials

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 Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00366652·20 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

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

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT00500721·22 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

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

15 more indications

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

Back pain1 trial

Effect of Antidepressants on Back Pain

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

Gastric Emptying1 trial

Tricyclic Antidepressants (TCAs) on Gastric Emptying

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

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

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

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

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

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

Platelet Function1 trial

Depression, Epinephrine, and Platelet Function

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

Nov 20, 1964

NORPRAMIN

NDA NDA014399

Jul 2, 1974

NORPRAMIN

NDA NDA014399

Apr 4, 1975

NORPRAMIN

NDA NDA014399

Apr 15, 1975

NORPRAMIN

NDA NDA014399

Oct 6, 1975

NORPRAMIN

NDA NDA014399

May 28, 1976

NORPRAMIN

NDA NDA014399

Jun 25, 1976

NORPRAMIN

NDA NDA014399

Mar 1, 1977

NORPRAMIN

NDA NDA014399

Feb 14, 1980

NORPRAMIN

NDA NDA014399

Jul 28, 1980

NORPRAMIN

NDA NDA014399

Aug 18, 1980

NORPRAMIN

NDA NDA014399

Jan 1, 1982

PERTOFRANE

NDA NDA013621

Feb 1, 1982

NORPRAMIN

NDA NDA014399

Feb 1, 1982

NORPRAMIN

NDA NDA014399

Feb 1, 1982

NORPRAMIN

NDA NDA014399

Feb 1, 1982

NORPRAMIN

NDA NDA014399

Feb 11, 1982

NORPRAMIN

NDA NDA014399

Feb 11, 1982

NORPRAMIN

NDA NDA014399

Jun 22, 1982

NORPRAMIN

NDA NDA014399

Jun 22, 1982

NORPRAMIN

NDA NDA014399

Apr 29, 1985

NORPRAMIN

NDA NDA014399

Jun 24, 1986

NORPRAMIN

NDA NDA014399

Apr 3, 1987

NORPRAMIN

NDA NDA014399

Mar 30, 1988

NORPRAMIN

NDA NDA014399

Jun 20, 1988

NORPRAMIN

NDA NDA014399

Nov 15, 1988

NORPRAMIN

NDA NDA014399

Mar 21, 1989

NORPRAMIN

NDA NDA014399

Jun 19, 1989

NORPRAMIN

NDA NDA014399

Apr 25, 1990

NORPRAMIN

NDA NDA014399

Dec 10, 1990

NORPRAMIN

NDA NDA014399

Dec 10, 1990

NORPRAMIN

NDA NDA014399

Dec 11, 1991

NORPRAMIN

NDA NDA014399

Dec 11, 1991

NORPRAMIN

NDA NDA014399

Sep 3, 1992

NORPRAMIN

NDA NDA014399

May 23, 2000

NORPRAMIN

NDA NDA014399

May 23, 2000

NORPRAMIN

NDA NDA014399

May 23, 2000

NORPRAMIN

NDA NDA014399

May 23, 2000

NORPRAMIN

NDA NDA014399

Jan 12, 2005

NORPRAMIN

NDA NDA014399

Apr 11, 2006

NORPRAMIN

NDA NDA014399

Jul 30, 2007

NORPRAMIN

NDA NDA014399

Oct 26, 2009

NORPRAMIN

NDA NDA014399

Nov 19, 2012

NORPRAMIN

NDA NDA014399

Nov 19, 2012

NORPRAMIN

NDA NDA014399

Jul 2, 2014

NORPRAMIN

NDA NDA014399

Aug 7, 2014

NORPRAMIN

NDA NDA014399

Nov 9, 2018

NORPRAMIN

NDA NDA014399

Jun 24, 2025

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

Randomized1 trial

Major Depression1 trial

Back pain1 trial

Gastric Emptying1 trial

Treatment1 trial

Drug Therapy1 trial

Methamphetamine Abuse1 trial

Irritable Bowel Syndrome1 trial

Obstructive Sleep Apnea1 trial

Postherpetic Neuralgia1 trial

Adult1 trial

Functional Bowel Disorder1 trial

Infusion1 trial

Chronic pain1 trial

Platelet Function1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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