Elavil

(Amitriptyline)

ApprovedSmall molecule

Amitriptyline is used to treat depression by increasing amounts of certain natural chemicals in the brain needed for mental balance. It belongs to a class of older antidepressants and may also be used for nerve pain, eating disorders, and migraine prevention.[2] Elavil is currently approved and in use across 25 indications[4].[1]

Elavil is one of 438 small molecule programs targeting Diabetic Neuropathy. It is currently in Approved.

Indications

Total Trials

Active Trials

437

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Diabetic NeuropathyApproved

Frozen ShoulderApproved

Reproductive System DiseaseApproved

Intervertebral Disc DisplacementApproved

NeuropathyApproved

Biliary DyskinesiaApproved

Gastroesophageal Reflux DiseaseActive, not recruiting

Depressive DisorderActive, not recruiting

Gastrointestinal DiseaseApproved

Laryngeal DiseaseApproved

Diabetic NeuropathyApproved

Approved

Frozen ShoulderApproved

Approved

Reproductive System DiseaseApproved

Approved

Intervertebral Disc DisplacementApproved

Approved

NeuropathyApproved

Approved

Biliary DyskinesiaApproved

Approved

Gastroesophageal Reflux DiseasePreclinical

Active, not recruiting

Depressive DisorderApproved

Active, not recruiting

Gastrointestinal DiseaseApproved

Approved

Laryngeal DiseaseApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

105 competitors in Migraine

#DrugCompanyPhaseTrials

Elavil

AstraZeneca

Approved

11 2

Zonegran

AAzurity Pharmaceuticals

Phase 3

3 3

Magnesium

SSpherium Biomed

Phase 3

3 4

Triptans

Pfizer

Phase 3

2 5

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 6

BAT7104

Teva

Phase 3

1 7

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 8

Tizanidine Hydrochloride

EElan Pharmaceuticals

Phase 3

1 9

Bayer Aspirin

Bayer

Preclinical

2 10

Cymbalta

Jazz Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Interstitial Lung Disease

NCT05120934

Phase 2Recruiting

Chronic Cough

NCT05110144

Post-ApprovalNot yet recruiting

Migraine

NCT06499116

Q4 2027

PreclinicalRecruiting

Headache

NCT05889624

Q4 2028

Phase 2Recruiting

Rosacea

NCT06312813

Q3 2032

Phase 1Not yet recruiting

Burn

NCT07716722

Clinical

Trials by Indication[1]

Migraine11 trials

Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis

Unknown status·—·Phase 4·NCT05759845·150 enrolled

Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis

Unknown status·—·N/A·NCT06162819·84 enrolled

Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation

Completed·RRambam Health Care Campus·N/A·NCT02101892·54 enrolled

Show 8 more trials

Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine

Enrolling by invitation·VVanderbilt University Medical Center·Phase 1·NCT06417684·100 enrolled

Mind and Body Approaches to Pain Reduction in Youth With Migraine

Completed·—·Phase 2·NCT03472092·132 enrolled

Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine

Completed·HHospital Israelita Albert Einstein·Phase 3·NCT01357031·192 enrolled

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

Not yet recruiting·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 4·NCT06499116·460 enrolled

The Childhood and Adolescent Migraine Prevention Study

Terminated·—·Phase 3·NCT01581281·488 enrolled

Amitriptyline vs GON and SON Blocks in Migraine

Completed·—·N/A·NCT04750967·57 enrolled

Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Completed·RRambam Health Care Campus·N/A·NCT01161017·67 enrolled

A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine

Terminated·RRutgers, The State University of New Jersey·Approved·NCT02090998·10 enrolled

Treatment7 trials

Novel Topical Therapies for the Treatment of Genital Pain

Completed·UUniversity of Rochester·Phase 2/3·NCT02099006·9 enrolled

Treatment of Chronic Laryngitis With Amitriptyline

Terminated·—·Phase 2/3·NCT02552225·6 enrolled

Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Terminated·—·Phase 2/3·NCT02434523·30 enrolled

Show 4 more trials

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02256956·48 enrolled

Physiology of GERD and Treatment Response

Completed·UUniversity of California, Davis·N/A·NCT04292470·7 enrolled

Sham Device, Pill Placebo or Treatment For Arm Pain

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00029497·240 enrolled

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02256943·48 enrolled

Neuropathic Pain4 trials

Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

Completed·IInstitut Claudius Regaud·Phase 2·NCT04704453·13 enrolled

Treatment of Neuropathic Pain in Leprosy

Unknown status·UUniversity of Sao Paulo·Phase 3·NCT03324035·102 enrolled

Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

Completed·TThe Hospital for Sick Children·Phase 3·NCT00312260·34 enrolled

Show 1 more trial

Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer

Unknown status·RRadboud University Medical Center·Phase 3·NCT00740571·130 enrolled

Headache4 trials

Medical Therapies for Chronic Post-Traumatic Headaches

Terminated·MMadigan Army Medical Center·Phase 4·NCT00862095·64 enrolled

Pediatric Chronic Headache Trial

Unknown status·—·Phase 3·NCT00389038·132 enrolled

Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Completed·DDanish Headache Center·N/A·NCT02746250·46 enrolled

Show 1 more trial

Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Preclinical·NCT05889624·400 enrolled

Fibromyalgia4 trials

Combining N-of-1 Trials to Assess Fibromyalgia Treatments

Completed·TTufts Medical Center·Phase 4·NCT00000428·58 enrolled

Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

Completed·MMansoura University·Phase 1/2·NCT02451475·75 enrolled

The Effect of Central Sensitization on Treatment Response in Patients With Fibromyalgia

Unknown status·MMarmara University··NCT05020600·40 enrolled

Show 1 more trial

Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia

Completed·UUniversidad de Granada·Phase 4·NCT00766350·90 enrolled

39 more indications

Irritable Bowel Syndrome2 trials

Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Withdrawn·TTehran University of Medical Sciences·Phase 4·NCT02190526

Unknown status·SSamsung Medical Center··NCT02638870·118 enrolled

Major Depressive Disorder2 trials

Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)

Completed·Ee-Therapeutics PLC·Phase 2·NCT02014363·164 enrolled

Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00351910·494 enrolled

Brain Injury1 trial

Amitriptyline to Prevent Headache After Traumatic Brain Injury

Completed·UUniversity of Washington·Phase 2·NCT01856270·50 enrolled

Interstitial Lung Disease1 trial

Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough

Recruiting·MMayo Clinic·Phase 2·NCT05120934·25 enrolled

Chronic Cough1 trial

Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough

Recruiting·MMayo Clinic·Phase 2·NCT05110144·50 enrolled

Tics1 trial

A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects

Unknown status·—·Phase 1·NCT02519400·24 enrolled

Rosacea1 trial

Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Recruiting·WWright State University·Phase 2·NCT06312813·48 enrolled

Cognition1 trial

Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.

Terminated·UUMC Utrecht·Phase 4·NCT00189059·24 enrolled

Chronic pain1 trial

Chronic Pain After Amputation

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 4·NCT00006427·125 enrolled

Children1 trial

Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

Completed·—·Phase 2·NCT01206478·21 enrolled

Minocycline1 trial

Effect of Minocycline on Pain Caused by Nerve Damage

Completed·ZZiekenhuis Oost-Limburg·Phase 4·NCT01869907·60 enrolled

Pregabalin1 trial

Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

Completed·UUniversity of Surrey·Phase 2/3·NCT00370656·90 enrolled

Pain1 trial

Myofascial Pain Patients' Response to the Administration of Low Doses of Amitriptyline and Citalopram Compared With the Use of Bite Splint

Unknown status·UUniversity of Coimbra·Phase 2/3·NCT04777838·80 enrolled

LAM1 trial

Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo

Completed·UUniversity Hospital Tuebingen·Phase 2·NCT00515229·18 enrolled

Prospective1 trial

Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain

Unknown status·DDoron Aframian·Phase 4·NCT02339662·50 enrolled

Laparoscopic Cholecystectomy1 trial

Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

Unknown status·—·Phase 2·NCT02195115·60 enrolled

Cystic Fibrosis1 trial

Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo

Unknown status·UUniversity Children's Hospital Tuebingen·Phase 2·NCT01309178·30 enrolled

Hypoglycemia1 trial

Amitriptyline in Treating Hypoglycemia

Terminated·UUniversity of Utah·Phase 2·NCT03591458·2 enrolled

Gastric Emptying1 trial

Tricyclic Antidepressants (TCAs) on Gastric Emptying

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

Autism Spectrum Disorder1 trial

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

Terminated·UUniversity of Missouri, Kansas City·Phase 3·NCT04725383·1 enrolled

Completed·—·Phase 4·NCT00564525·95 enrolled

Treatment Resistant Depression1 trial

Interpersonal Psychotherapy for Treatment Resistant Depression

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

Conditioning1 trial

Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Completed·WWinfried Rief·N/A·NCT02127736

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

Insomnia1 trial

Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

Terminated·PPhilipps University Marburg·Phase 3·NCT02139098·23 enrolled

Dyspepsia1 trial

Functional Dyspepsia Treatment Trial

Completed·MMayo Clinic·Phase 2/3·NCT00248651·292 enrolled

Adjuvant Treatment1 trial

Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial

Unknown status·UUniversity of Campinas, Brazil·Phase 3·NCT02871661·58 enrolled

Painful Bladder Syndrome1 trial

Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00124306·271 enrolled

Major Depression1 trial

Amitriptyline and Paroxetine Treatment of Major Depression

Completed·—·Phase 3·NCT01049347·127 enrolled

Adhesive Capsulitis1 trial

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

Completed·—·Phase 2·NCT01306708·34 enrolled

Female1 trial

Study to Evaluate the Effect Single and Multiple Oral Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256878·24 enrolled

Aesthetic1 trial

Local Anaesthetic Effects of Transcutaneous Amitriptyline

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 1·NCT00355277·16 enrolled

Hysterectomy1 trial

Preemptive Analgesia With Amitryptyline for Prevention of Pain in Women After Hysterectomy

Completed·UUniversity of Campinas, Brazil·Phase 3·NCT03587025·150 enrolled

Ketamine1 trial

Effect of Ketamine, Amitriptyline and Their Combination on Itch

Completed·—·N/A·NCT06245564·30 enrolled

Burn1 trial

Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline

Not yet recruiting·WWright State University·Phase 1·NCT07716722·50 enrolled

Microvesicle Particles1 trial

Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release

Not yet recruiting·WWright State University·Phase 1·NCT07640061·20 enrolled

Unspecified2 trials

The Influence of Amitriptyline on Learning in a Visual Discrimination Task

Completed·—·N/A·NCT01566825·32 enrolled

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ELAVIL

NDA NDA012704

Jan 1, 1982

ELAVIL

NDA NDA012703

Sources

References

[1]
ClinicalTrials.gov — 72 trial records for Amitriptyline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Elavil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amitriptyline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amitriptyline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA012704). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Elavil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2028

Q3 2032

Trials by Indication[1]

Migraine11 trials

Treatment7 trials

Neuropathic Pain4 trials

Headache4 trials

Fibromyalgia4 trials

Irritable Bowel Syndrome2 trials

Major Depressive Disorder2 trials

Brain Injury1 trial

Interstitial Lung Disease1 trial

Chronic Cough1 trial

Tics1 trial

Rosacea1 trial

Cognition1 trial

Chronic pain1 trial

Children1 trial

Minocycline1 trial

Pregabalin1 trial

Pain1 trial

LAM1 trial

Prospective1 trial

Laparoscopic Cholecystectomy1 trial

Cystic Fibrosis1 trial

Hypoglycemia1 trial

Gastric Emptying1 trial

Autism Spectrum Disorder1 trial

Spinal Cord Injury1 trial

RCT1 trial

Abdominal pain1 trial

Treatment Resistant Depression1 trial

Conditioning1 trial

Medication1 trial

Insomnia1 trial

Dyspepsia1 trial

Adjuvant Treatment1 trial

Painful Bladder Syndrome1 trial

Major Depression1 trial

Adhesive Capsulitis1 trial

Female1 trial

Aesthetic1 trial

Hysterectomy1 trial

Ketamine1 trial

Burn1 trial

Microvesicle Particles1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News