Pamelor

(Nortriptyline)

ApprovedSmall molecule

Nortriptyline is a tricyclic antidepressant that helps treat depression by restoring the balance of certain natural chemicals in the brain. It works to improve mood and mental balance.[2] Pamelor is currently approved and in use across 12 indications[4].[1]

Pamelor is one of 273 small molecule programs targeting Nicotine Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

272

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Nicotine DependenceApproved

Depressive DisorderActive, not recruiting

MelancholiaActive, not recruiting

ConcussionTerminated

Gastroesophageal Reflux DiseaseApproved

Abdominal PainActive, not recruiting

MigraineActive, not recruiting

Major Depressive DisorderActive, not recruiting

Bipolar DisorderCompleted

Elderly PatientsCompleted

Nicotine DependenceApproved

Approved

Depressive DisorderApproved

Active, not recruiting

MelancholiaApproved

Active, not recruiting

ConcussionApproved

Terminated

Gastroesophageal Reflux DiseaseApproved

Approved

Abdominal PainPreclinical

Active, not recruiting

MigraineApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

Bipolar DisorderApproved

Completed

Elderly PatientsPreclinical

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

115 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Pamelor

SSpecgx

Approved

27 2

Ritalin

Novartis

Approved

2 3

Olumiant

Eli Lilly

Approved

1 4

Victoza

Mifeprex

1 6

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 7

Ketalar

Boehringer Ingelheim

Phase 3

5 8

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 9

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 10

Psilocybin

COMPASS Pathways

Phase 3

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

Timeline

Expected Milestones

Q4 2030

ApprovedNot yet recruiting

Migraine

NCT07856056

Clinical

Trials by Indication[1]

Parkinson's Disease2 trials

Antidepressants Trial in Parkinson's Disease

Completed·UUniversity College, London·Phase 3·NCT03652870·52 enrolled

Treatment of Depression in Parkinson's Disease Trial

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT00062738·52 enrolled

Migraine2 trials

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Terminated·SSt. Louis University·N/A·NCT02169830·35 enrolled

A Randomized Double Blind Parallel Group Trial Comparing Nortriptyline With Amitriptyline for the Preventive Treatment of Episodic Migraine in Adults at Sultan Qaboos University Hospital

Not yet recruiting·SSultan Qaboos University·Approved·NCT07856056·90 enrolled

Dyspepsia2 trials

Nortriptyline for the Treatment of Functional Dyspepsia

Terminated·MMaastricht University Medical Center·Phase 3·NCT03652571·96 enrolled

Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

Terminated·TThe Cleveland Clinic·Preclinical·NCT00547703·5 enrolled

Depression2 trials

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00021528·4,000 enrolled

Optimizing Electroconvulsive Therapy for Depression

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00045916·340 enrolled

Medication1 trial

Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene

Unknown status·HHolsboerMaschmeyer NeuroChemie GmbH·Phase 4·NCT02237937·80 enrolled

18 more indications

Bipolar Disorder1 trial

Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02918097·78 enrolled

Major Depression1 trial

Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02901249·68 enrolled

Heartburn1 trial

Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients

Completed·UUniversidade de Passo Fundo·Phase 3·NCT01065649·20 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

Sciatica1 trial

Pain Treatment for Sciatica

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00009672·80 enrolled

Psoriasis1 trial

A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis

Completed·ZZalicus·Phase 2·NCT00796211·20 enrolled

Concussion1 trial

Pediatric Concussion Outcomes

Terminated·—·Phase 4·NCT04226365·8 enrolled

Prevention1 trial

Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)

Terminated·HHillerod Hospital, Denmark·Phase 4·NCT00660062·47 enrolled

Pathophysiology1 trial

Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

Completed·—·Phase 2·NCT03844412·209 enrolled

Irritable Bowel Syndrome1 trial

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Completed·—·Phase 2·NCT01268709

Melancholia1 trial

Antidepressant Treatment of Melancholia in Late Life

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00000378·110 enrolled

Treatment Resistant Depression1 trial

Interpersonal Psychotherapy for Treatment Resistant Depression

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

Temporomandibular Joint Disorder1 trial

Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)

Completed·JJohns Hopkins University·Phase 2·NCT00066937·140 enrolled

Neuropathy1 trial

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

Completed·UUniversity of Kansas Medical Center·Phase 4·NCT02260388·402 enrolled

Elderly Patients1 trial

Preventing the Return of Depression in Elderly Patients

Completed·UUniversity of Pittsburgh·N/A·NCT00000377

Smoking Cessation1 trial

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018148·158 enrolled

Tinnitus1 trial

Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial

Suspended·UUniversity of California, Irvine·Approved·NCT06799169·100 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[5]

Jun 29, 1978

PAMELOR

NDA NDA018013

Jun 14, 1979

PAMELOR

NDA NDA018013

Sep 17, 1979

PAMELOR

NDA NDA018013

Nov 20, 1979

PAMELOR

NDA NDA018013

Jun 26, 1981

PAMELOR

NDA NDA018013

Jul 24, 1981

PAMELOR

NDA NDA018013

Jan 1, 1982

PAMELOR

NDA NDA018012

Jan 1, 1982

AVENTYL HYDROCHLORIDE

NDA NDA014684

Jan 1, 1982

AVENTYL

NDA NDA014685

Jan 1, 1982

PAMELOR

NDA NDA018013

Feb 18, 1982

PAMELOR

NDA NDA018013

Mar 25, 1982

PAMELOR

NDA NDA018013

Jun 2, 1982

PAMELOR

NDA NDA018013

May 1, 1984

PAMELOR

NDA NDA018013

Dec 11, 1984

PAMELOR

NDA NDA018013

Jun 11, 1985

PAMELOR

NDA NDA018013

Jun 27, 1985

PAMELOR

NDA NDA018013

Aug 25, 1986

PAMELOR

NDA NDA018013

Nov 7, 1988

PAMELOR

NDA NDA018013

Nov 7, 1989

PAMELOR

NDA NDA018013

Jan 16, 1990

PAMELOR

NDA NDA018013

Mar 26, 1990

PAMELOR

NDA NDA018013

Mar 13, 1991

PAMELOR

NDA NDA018013

Aug 2, 1991

PAMELOR

NDA NDA018013

Jan 21, 1992

PAMELOR

NDA NDA018013

Mar 12, 1992

PAMELOR

NDA NDA018013

Jun 10, 1993

PAMELOR

NDA NDA018013

Jun 16, 1993

PAMELOR

NDA NDA018013

Jun 16, 1993

PAMELOR

NDA NDA018013

Jul 23, 1993

PAMELOR

NDA NDA018013

Jul 23, 1993

PAMELOR

NDA NDA018013

Aug 17, 1993

PAMELOR

NDA NDA018013

Aug 26, 1993

PAMELOR

NDA NDA018013

Oct 6, 1993

PAMELOR

NDA NDA018013

Apr 1, 1994

PAMELOR

NDA NDA018013

Apr 15, 1994

PAMELOR

NDA NDA018013

Jul 7, 1994

PAMELOR

NDA NDA018013

Sep 18, 1995

PAMELOR

NDA NDA018013

Dec 7, 1995

PAMELOR

NDA NDA018013

Apr 15, 1999

PAMELOR

NDA NDA018013

Apr 28, 1999

PAMELOR

NDA NDA018013

Apr 27, 2000

PAMELOR

NDA NDA018013

Jun 7, 2001

PAMELOR

NDA NDA018013

Jul 31, 2001

PAMELOR

NDA NDA018013

Dec 6, 2004

PAMELOR

NDA NDA018013

Jan 12, 2005

PAMELOR

NDA NDA018013

Jul 13, 2007

PAMELOR

NDA NDA018013

Oct 26, 2012

PAMELOR

NDA NDA018013

Jul 10, 2014

PAMELOR

NDA NDA018013

Jul 28, 2014

PAMELOR

NDA NDA018013

Apr 9, 2019

PAMELOR

NDA NDA018013

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Nortriptyline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pamelor drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nortriptyline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nortriptyline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018013). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Specgx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Pamelor

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2030

Trials by Indication[1]

Parkinson's Disease2 trials

Migraine2 trials

Dyspepsia2 trials

Depression2 trials

Medication1 trial

Bipolar Disorder1 trial

Major Depression1 trial

Heartburn1 trial

Postherpetic Neuralgia1 trial

Sciatica1 trial

Psoriasis1 trial

Concussion1 trial

Prevention1 trial

Pathophysiology1 trial

Irritable Bowel Syndrome1 trial

Melancholia1 trial

Treatment Resistant Depression1 trial

Temporomandibular Joint Disorder1 trial

Neuropathy1 trial

Elderly Patients1 trial

Smoking Cessation1 trial

Tinnitus1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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