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 276 small molecule programs targeting Gastroesophageal Reflux Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

275

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Gastroesophageal Reflux DiseaseApproved

Depressive DisorderActive, not recruiting

Major Depressive DisorderActive, not recruiting

Nicotine DependenceApproved

MelancholiaActive, not recruiting

MigraineActive, not recruiting

Abdominal PainActive, not recruiting

Treatment Resistant DepressionActive, not recruiting

Elderly PatientsCompleted

ConcussionTerminated

Gastroesophageal Reflux DiseaseApproved

Approved

Depressive DisorderApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

MelancholiaApproved

Active, not recruiting

MigraineApproved

Active, not recruiting

Abdominal PainPreclinical

Active, not recruiting

Treatment Resistant DepressionPreclinical

Active, not recruiting

Elderly PatientsPreclinical

Completed

ConcussionApproved

Terminated

Showing 10 of 12 indications

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Pamelor

SSpecgx

Approved

26 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Clozaril

LLife Extension Foundation 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

Q4 2026

Post-ApprovalActive, not recruiting

Migraine

NCT06799169

Clinical

Trials by Indication[1]

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

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

Parkinson's Disease2 trials

Treatment of Depression in Parkinson's Disease Trial

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

Antidepressants Trial in Parkinson's Disease

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

Irritable Bowel Syndrome1 trial

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Completed·—·Phase 2·NCT01268709

17 more indications

Melancholia1 trial

Antidepressant Treatment of Melancholia in Late Life

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

Smoking Cessation1 trial

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

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

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

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

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

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

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

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]

Migraine2 trials

Dyspepsia2 trials

Depression2 trials

Parkinson's Disease2 trials

Irritable Bowel Syndrome1 trial

Melancholia1 trial

Smoking Cessation1 trial

Postherpetic Neuralgia1 trial

Sciatica1 trial

Psoriasis1 trial

Bipolar Disorder1 trial

Major Depression1 trial

Medication1 trial

Concussion1 trial

Prevention1 trial

Pathophysiology1 trial

Treatment Resistant Depression1 trial

Temporomandibular Joint Disorder1 trial

Neuropathy1 trial

Elderly Patients1 trial

Heartburn1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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