Drugs / Amitriptyline
last change Aug 2026 re-read 2 minutes ago

Amitriptyline

Small molecule

Developed for
depressive disorder · fibromyalgia · peripheral neuropathy · dyspepsia · laryngeal disorder · migraine disorder · neuropathy, painful · peripheral nervous system disorder
+42 more · avoidant/restrictive food intake disorder · carpal tunnel syndrome · chemotherapy-induced neuropathy · chronic pain syndrome · Crohn disease · diabetes mellitus · female reproductive system disorder · gastroesophageal reflux disease · headache disorder · inflammatory bowel disease · interstitial lung disease · irritable bowel syndrome · major depressive disorder · migraine with aura · migraine without aura · occupational disorder · radiation-induced neuropathy · rosacea · sleep disorder, initiating and maintaining sleep · spinal cord injury · toxic polyneuropathy · traumatic brain injury · type 1 diabetes mellitus · vertebral column disorder · autism spectrum disorder · biliary dyskinesia · cancer · cystic fibrosis · diabetic polyneuropathy · erythromelalgia · frozen shoulder · insomnia · interstitial cystitis · myofascial pain syndrome · neuralgia · obsessive-compulsive disorder · postherpetic neuralgia · radiculopathy · temporomandibular joint disorder · tinnitus · urinary bladder disorder · vulvodynia
Investigated by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Boehringer Ingelheim · Boston Medical Center · Mayo Clinic · National Cancer Institute (NCI) · National Center for Complementary and Integrative Health (NCCIH)
+65 more · National Institute of Allergy and Infectious Diseases (NIAID) · Wright State University · Aalborg University · AlgoTherapeutix · Alliance for Clinical Trials in Oncology · American College of Gastroenterology · American Laryngological Association · Ann & Robert H Lurie Children's Hospital of Chicago · Ann Davis, PhD, MPH, ABPP · Asan Medical Center · Blantyre College of Medicine · Brigham and Women's Hospital · British Columbia Cancer Agency · Children's Hospital Medical Center, Cincinnati · Chonbuk National University Hospital · Cristália Produtos Químicos Farmacêuticos Ltda. · Dong Wha Pharmaceutical Co. Ltd. · First Affiliated Hospital of Zhejiang University · Gary Morrow · Gil Yosipovitch · Hannover Medical School · HolsboerMaschmeyer NeuroChemie GmbH · Hospital de Clinicas de Porto Alegre · Hunan DongtingPharm.Co.Ltd · Institut Català de la Salut · Institut Claudius Regaud · Jordi Gol Institute for Primary Care Research · KAZM Pharmaceuticals Inc. · Madigan Army Medical Center · Mae Stone Goode Foundation · Mansoura University · Max-Planck-Institute of Psychiatry · McGill University Health Centre/Research Institute of the McGill University Health Centre · McMaster University · Md. Moktadirul Hoque Shuvo · Ministry of Health, Malawi · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Mental Health (NIMH) · Partners in Health · Patient-Centered Outcomes Research Institute · Polyclinique de l'Europe · RAND · Sant Pau Research Institute · Shalamar Institute of Health Sciences · Tabriz University · Tehran University of Medical Sciences · Temple University · The Leona M. and Harry B. Helmsley Charitable Trust · Tillotts Pharma AG · Tufts Medical Center · U.S. Army Medical Research and Development Command · UMC Utrecht · University Hospital, Clermont-Ferrand · University Medical Center Goettingen · University of Birmingham · University of California, Davis · University of Michigan · University of Rochester · University of Sao Paulo · University of Surrey · University of Utah · University of Washington · Utrecht University · VA Office of Research and Development · Winfried Rief

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ELAVIL 1961-04-07 fda.gov

Trials 53 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07640061 Jun 2027 → Jun 2033 expected Wright State University Not yet recruiting No outcome recorded
Phase 1 NCT03646526 Apr 2018 → Jan 2019 depressive disorder First Affiliated Hospital of Zhejiang University Completed No outcome recorded
Phase 1 NCT02519400 Aug → Oct 2015 depressive disorder Asan Medical Center Unknown No outcome recorded
Phase 1 NCT02054299 Apr 2013 → Feb 2016 University Medical Center Goettingen Completed No outcome recorded
Phase 1 NCT01367080 Jul → Aug 2011 depressive disorder, enuresis Dong Wha Pharmaceutical Co. Ltd. Completed No outcome recorded
Phase 1 NCT00355277 Nov 2005 → Dec 2007 University Hospital, Clermont-Ferrand Completed No outcome recorded
Phase 1 NCT02256878 Aug 2004 → Nov 2006 Boehringer Ingelheim Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02451475 Feb 2013 → Sep 2014 fibromyalgia Mansoura University Completed No outcome recorded
Phase 214 trials
Phase 2 NCT07556718 Jun 2026 → Dec 2029 expected Crohn disease University of Michigan Recruiting No outcome recorded
Phase 2 NCT06261320 Feb 2024 → Dec 2026 expected inflammatory bowel disease Polyclinique de l'Europe Active not recruiting No outcome recorded
Phase 2 NCT06312813 Feb 2024 → Dec 2028 expected rosacea Wright State University Recruiting No outcome recorded
Phase 2 NCT05593614 Feb 2023 → Sep 2024 overdue chemotherapy-induced neuropathy AlgoTherapeutix Active not recruiting No outcome recorded
Phase 2 NCT05110144 Nov 2021 → Dec 2026 expected Mayo Clinic Recruiting No outcome recorded
Phase 2 NCT05120934 Nov 2021 → Oct 2026 expected interstitial lung disease Mayo Clinic Recruiting No outcome recorded
Phase 2 NCT04704453 Apr 2021 → Apr 2025 head and neck cancer Institut Claudius Regaud Completed No outcome recorded
Phase 2 NCT03591458 Aug 2018 → Jun 2019 type 1 diabetes mellitus University of Utah Terminated No outcome recorded
Phase 2 NCT03096444 May → Jul 2017 Gil Yosipovitch Terminated No outcome recorded
Phase 2 NCT01856270 Apr 2013 → Feb 2016 traumatic brain injury University of Washington Completed No outcome recorded
Phase 2/36 trials
Phase 2/3 NCT07008235 Jul 2025 → Jun 2026 overdue dyspepsia Md. Moktadirul Hoque Shuvo Recruiting No outcome recorded
Phase 2/3 NCT02552225 Apr 2016 → Jan 2021 laryngeal disorder Boston Medical Center Terminated No outcome recorded
Phase 2/3 NCT02099006 Nov 2013 → Jun 2015 female reproductive system disorder University of Rochester Completed No outcome recorded
Phase 2/3 NCT02434523 Sep 2013 → Jan 2015 laryngeal disorder Boston Medical Center Terminated No outcome recorded
Phase 2/3 NCT02041455 Jun 2010 → Jan 2014 fibromyalgia Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 2/3 NCT00370656 Feb 2007 → May 2009 diabetes mellitus, peripheral neuropathy University of Surrey Completed No outcome recorded
Phase 36 trials
Phase 3 NCT06202989 Sep 2024 → May 2026 KAZM Pharmaceuticals Inc. Completed No outcome recorded
Phase 3 NCT03324035 Mar 2017 → May 2021 leprosy, neuropathy, painful, peripheral neuropathy University of Sao Paulo Unknown No outcome recorded
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT00798083 Apr 2008 → Jul 2009 radiation-induced neuropathy British Columbia Cancer Agency Completed No outcome recorded
Phase 3 NCT00516503 Feb 2008 → Apr 2009 cancer of unknown primary site, leukemia, lymphoproliferative syndrome, myelodysplastic syndrome +4 Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 3 NCT00471445 Oct 2007 → Sep 2013 cancer of unknown primary site, chemotherapy-induced toxicity, peripheral neuropathy Gary Morrow Completed No outcome recorded
Phase 410 trials
Phase 4 NCT06499116 Oct 2024 → Dec 2026 expected migraine disorder Jordi Gol Institute for Primary Care Research Not yet recruiting No outcome recorded
Phase 4 NCT04777006 Sep 2021 → Apr 2023 depressive disorder RAND Completed No outcome recorded
Phase 4 NCT02190526 Sep 2014 → Dec 2015 irritable bowel syndrome Tehran University of Medical Sciences Withdrawn No outcome recorded
Phase 4 NCT02237937 Sep 2011 → Dec 2014 major depressive disorder HolsboerMaschmeyer NeuroChemie GmbH Unknown No outcome recorded
Phase 4 NCT00862095 Jun 2008 → Apr 2013 headache disorder Madigan Army Medical Center Terminated No outcome recorded
Phase 4 NCT00189059 Oct 2002 → May 2005 neuropathy, painful UMC Utrecht Terminated No outcome recorded
Phase 4 NCT00564525 Oct 2002 → Jun 2007 Ann & Robert H Lurie Children's Hospital of Chicago Completed No outcome recorded
Phase 4 NCT00000428 Sep 2000 → Mar 2004 fibromyalgia Tufts Medical Center Completed No outcome recorded
Phase 4 NCT00006428 Aug 1996 → May 2007 spinal cord injury Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed No outcome recorded
Phase 4 NCT00006427 Aug 1996 → Jul 2001 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed No outcome recorded
Phase not applicable9 trials
NCT06245564 Aug → Dec 2024 Aalborg University Completed No outcome recorded
NCT06162819 Jan → Jun 2024 migraine disorder Shalamar Institute of Health Sciences Unknown No outcome recorded
NCT05889624 Aug 2023 → Jul 2027 expected migraine with aura, migraine without aura Children's Hospital Medical Center, Cincinnati Recruiting No outcome recorded
NCT04292470 Nov 2020 → Nov 2021 gastroesophageal reflux disease University of California, Davis Completed No outcome recorded
NCT00386243 Dec 2007 → May 2012 chronic pain syndrome VA Office of Research and Development Completed No outcome recorded
NCT00381199 Apr 2006 → Mar 2007 fibromyalgia, sleep disorder, initiating and maintaining sleep McGill University Health Centre/Research Institute of the McGill University Health Centre Completed No outcome recorded
NCT00220844 Sep 2005 → Jun 2014 dyspepsia Temple University Terminated No outcome recorded
NCT00000817 Nov 1994 → May 1997 HIV infectious disease, peripheral nervous system disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT02127736 ? → Sep 2014 Winfried Rief Completed No outcome recorded
Also used as a comparator or background therapy in 56 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT06417684 Comparator Jun 2024 → Mar 2026 migraine disorder Vanderbilt University Medical Center Withdrawn No outcome recorded
Phase 0 NCT07016451 Background Apr 2024 → Sep 2025 radiation cystitis Ramathibodi Hospital Completed No outcome recorded
Phase 212 trials
Phase 2 NCT06091553 Comparator Oct 2023 → Sep 2024 peripheral neuropathy Beni-Suef University Unknown No outcome recorded
Phase 2 NCT05917912 Comparator Jun 2023 → Feb 2024 erythromelalgia AlgoTherapeutix Completed No outcome recorded
Phase 2 NCT06158230 Comparator Mar → Nov 2023 migraine disorder Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Unknown No outcome recorded
Phase 2 NCT03472092 Comparator Oct 2018 → Feb 2025 migraine disorder Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 2 NCT02195115 Comparator Feb 2014 → Jul 2015 biliary dyskinesia CAMC Health System Unknown No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT04777838 Comparator Mar → May 2021 myofascial pain syndrome, temporomandibular joint disorder University of Coimbra Unknown No outcome recorded
Phase 2/3 NCT04689971 Background Nov 2020 → Nov 2021 neuropathy, painful Duta Wacana Christian University Unknown No outcome recorded
Phase 2/3 NCT04689984 Background Nov 2020 → Nov 2021 diabetic polyneuropathy Duta Wacana Christian University Unknown No outcome recorded
Phase 2/3 NCT04689958 Background Nov 2020 → Nov 2021 diabetic polyneuropathy Duta Wacana Christian University Unknown No outcome recorded
Phase 2/3 NCT00248651 Comparator Oct 2006 → Jul 2013 dyspepsia Mayo Clinic Completed No outcome recorded
Phase 314 trials
Phase 3 NCT07296770 Background Oct 2026 → Dec 2027 expected chronic pain syndrome University of California, San Francisco Not yet recruiting No outcome recorded
Phase 3 NCT04725383 Comparator Nov 2023 → May 2025 autism spectrum disorder, obsessive-compulsive disorder University of Missouri, Kansas City Terminated No outcome recorded
Phase 3 NCT05658874 Background Dec 2022 → Dec 2024 interstitial cystitis, levator syndrome Jocelyn Fitzgerald Terminated No outcome recorded
Phase 3 NCT02871661 Comparator Jul 2016 → Oct 2017 vulvodynia University of Campinas, Brazil Unknown No outcome recorded
Phase 3 NCT03587025 Comparator Jun 2015 → Oct 2018 University of Campinas, Brazil Completed No outcome recorded
Phase 411 trials
Phase 4 NCT07655440 Comparator Jul 2026 → Jul 2031 expected migraine disorder, tinnitus, vestibular disorder Stanford University Not yet recruiting No outcome recorded
Phase 4 NCT05867550 Comparator Jan → Mar 2023 irritable bowel syndrome Bahria University Completed No outcome recorded
Phase 4 NCT05759845 Comparator Aug 2022 → Feb 2023 migraine disorder Dr. Reaz Mahmud Unknown No outcome recorded
Phase 4 NCT02670161 Comparator May 2016 → Dec 2026 expected Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6 Endeavor Health Enrolling by invitation No outcome recorded
Phase 4 NCT02339662 Comparator Feb 2015 → Jan 2016 myofascial pain syndrome Doron Aframian Unknown No outcome recorded
Phase not applicable12 trials
NCT06301061 Comparator Apr 2024 → Oct 2025 chronic pain syndrome, neuropathy, painful, radiculopathy Federico II University Unknown No outcome recorded
NCT07593313 Background Jan 2024 → Aug 2026 overdue Nanchong Central Hospital Recruiting No outcome recorded
NCT05690737 Comparator Sep 2023 → Dec 2025 overdue migraine disorder The Hong Kong Polytechnic University Recruiting No outcome recorded
NCT05753774 Comparator Aug 2022 → Aug 2026 overdue Biao Zou Recruiting No outcome recorded
NCT05279963 Comparator Mar 2022 → Dec 2024 overdue urinary bladder disorder The Third Affiliated hospital of Zhejiang Chinese Medical University Recruiting No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 111 sources stand behind the page.

FieldValueCited text
Known as amitriptyline “Fluoxetine, a serotonin selective reuptake inhibitor (SSRI), and amitriptyline, a tricyclic antidepressant (TCA), are part of Malawi's national formulary.” NCT04777006
106

“A bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.” NCT05593614

“The second line drug such as amitriptyline and the third line drug such as gabapentin will be adopted according to doctor's judgement if necessary.” NCT05690737

“Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%).” NCT06202989

“standard treatment (pregabalin, gabapentin, or amitriptyline) over eight weeks.” PMID 34984028 Dec 2021

“PURPOSE: Amitriptyline is the most widely used tricyclic antidepressant (TCA).” PMID 25308868 Oct 2014

“ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks” NCT00475904

“migraine (amitriptyline, propranolol, topiramate)” NCT02670161

Amitriptyline, start at 10-25, titrate to 100 mg” NCT00386243

“Gabapentin, pregabalin, or amitriptylineNCT04689984

“Gabapentin, pregabalin, or amitriptylineNCT04689971

Amitriptyline Hydrochloride” NCT07296770

“* AmitriptylineNCT07016451

NCT06261320

NCT00766350

NCT02090998

NCT04725383

NCT02099006

NCT00000428

NCT04704453

NCT01856270

NCT06245564

NCT02101892

NCT02014363

NCT00515229

NCT02451475

NCT04750967

NCT02256878

NCT06312813

NCT05120934

NCT02256943

NCT07593313

NCT02256956

NCT01869907

NCT01581281

NCT02195115

NCT02871661

NCT01309178

NCT02552225

NCT03472092

NCT06417684

NCT01896349

NCT00351910

NCT07556718

NCT00497562

NCT00355277

NCT04777838

NCT01306708

NCT01014520

NCT00029497

NCT00325000

NCT07640061

NCT01357031

NCT05658874

NCT00189059

NCT02237937

NCT00389038

NCT00798083

NCT02041455

NCT05110144

NCT06301061

NCT00124306

NCT05759845

NCT00564525

NCT02054299

NCT00220844

NCT02519400

NCT03646526

NCT00000793

NCT05917912

NCT02374567

NCT04523935

NCT07655440

NCT07008235

NCT05867550

NCT06162819

NCT04292470

NCT02339662

NCT02139098

NCT01161017

NCT06499116

NCT00248651

NCT00006427

NCT03587025

NCT00370656

NCT05889624

NCT00381199

NCT03591458

NCT05279963

NCT03324035

NCT00476151

NCT06091553

NCT01206478

NCT00312260

NCT00740571

NCT01566825

NCT00006428

NCT02190526

NCT00471445

NCT00000817

NCT02127736

NCT00862095

NCT02434523

NCT01049347

NCT05753774

NCT02746250

NCT06158230

Known as AMI “the drug amitriptyline (AMI)--CST-AMI--is effective” NCT00389038
Known as Amitriptylin-CT 25 mg “The Influence of Amitriptyline (Amitriptylin-CT 25 mg®) on Learning in a Visual Discrimination Task (Karni-Sagi-paradigm)” NCT01566825
Known as amitriptyline HCL “Patients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine...” PMID 20496177 May 2010
Known as amitriptyline hydrochloride “A multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10%...” NCT05593614
5

“Although amitriptyline hydrochloride 10 and 25 mg has been marketed in Korea, no data on the dose proportionality of amitriptyline in Korean subjects are available.” PMID 25308868 Oct 2014

amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations.” NCT03646526

Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes” NCT05867550

“ATX01 (Topical Amitriptyline Hydrochloride 15% w/w)” NCT05917912

NCT03096444

Known as ATX01 “A multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10%...” NCT05593614
1

ATX01 (Topical Amitriptyline Hydrochloride 15% w/w)” NCT05917912

Known as DWETR10 “Amitriptyline hydrochloride 10mg(DWETR10) single dose” NCT01367080
Known as DWETR25 “Amitriptyline hydrochloride 25mg(DWETR25) single dose” NCT01367080
Known as Elavil “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935
1

“Arm two will receive Amitriptyline / Elavil daily for 30 Days” NCT02090998

Action Inhibit “Inhalation of the Asm inhibitors amitriptyline, trimipramine, desipramine, chlorprothixene, fluoxetine, amlodipine, or sertraline restored normal ceramide concentrations in...” PMID 19635928 Jul 2009
Modality Small molecule “Amitriptyline is the most widely used tricyclic antidepressant (TCA).” PMID 25308868 Oct 2014
Route Oral “Amitriptyline 25 mg po” NCT00000428