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 18 indications[4].[1]

Pamelor is one of 482 small molecule programs targeting Dyspepsia. It is currently in Approved.

Indications

Total Trials

Active Trials

481

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

DyspepsiaActive, not recruiting

Nicotine DependenceApproved

Depressive DisorderActive, not recruiting

MelancholiaActive, not recruiting

Temporomandibular Joint DisorderActive, not recruiting

ConcussionActive, not recruiting

Gastroesophageal Reflux DiseaseApproved

SciaticaActive, not recruiting

Abdominal PainActive, not recruiting

Postherpetic NeuralgiaActive, not recruiting

DyspepsiaPhase 3

Active, not recruiting

Nicotine DependenceApproved

Approved

Depressive DisorderApproved

Active, not recruiting

MelancholiaApproved

Active, not recruiting

Temporomandibular Joint DisorderPhase 2

Active, not recruiting

ConcussionApproved

Active, not recruiting

Gastroesophageal Reflux DiseaseApproved

Approved

SciaticaPhase 2

Active, not recruiting

Abdominal PainPreclinical

Active, not recruiting

Postherpetic NeuralgiaPhase 3

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Pamelor

SSpecgx

Approved

1 2

Cosentyx

Novartis

Preclinical

53 3

Stelara

Johnson & Johnson

Preclinical

37 4

Taltz

Eli Lilly

Preclinical

20 5

Bimzelx

UCB

Preclinical

17 6

Humira

CCelltrion

Preclinical

42 7

Ilumya

Sun Pharmaceutical Industries, Inc.

Preclinical

15 8

Remicade

OOrganon and Co

Preclinical

20 9

Siliq

BBausch Health Americas, Inc.

Victoza

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Migraine

NCT06799169

Clinical

Trials by Indication[1]

Depression2 trials

Optimizing Electroconvulsive Therapy for Depression

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

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

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

Migraine2 trials

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

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

Management of Acute Tinnitus With Migraine Medications

Active, not recruiting·UUniversity of California, Irvine·Phase 4·NCT06799169·100 enrolled

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

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

Abdominal pain1 trial

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

Terminated·TThe Cleveland Clinic·N/A·NCT00547703·5 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

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

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

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

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

Concussion1 trial

Pediatric Concussion Outcomes

Terminated·—·Phase 4·NCT04226365·8 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

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

Smoking Cessation1 trial

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

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

Dyspepsia1 trial

Nortriptyline for the Treatment of Functional Dyspepsia

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

Irritable Bowel Syndrome1 trial

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Completed·—·Phase 2·NCT01268709

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

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

AVENTYL HYDROCHLORIDE

NDA NDA014684

Jan 1, 1982

PAMELOR

NDA NDA018013

Jan 1, 1982

AVENTYL

NDA NDA014685

Jan 1, 1982

PAMELOR

NDA NDA018012

Sources

References

[1]
ClinicalTrials.gov — 26 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 NDA014684). 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 2026

Trials by Indication[1]

Depression2 trials

Migraine2 trials

Parkinson's Disease2 trials

Heartburn1 trial

Abdominal pain1 trial

Bipolar Disorder1 trial

Major Depression1 trial

Psoriasis1 trial

Melancholia1 trial

Treatment Resistant Depression1 trial

Neuropathy1 trial

Elderly Patients1 trial

Postherpetic Neuralgia1 trial

Sciatica1 trial

Concussion1 trial

Medication1 trial

Prevention1 trial

Pathophysiology1 trial

Smoking Cessation1 trial

Dyspepsia1 trial

Irritable Bowel Syndrome1 trial

Temporomandibular Joint Disorder1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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