Amitriptyline
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ELAVIL | — | 1961-04-07 | fda.gov ↗ |
Trials 53 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT01206478 | Aug 2010 → Dec 2014 | avoidant/restrictive food intake disorder | Ann Davis, PhD, MPH, ABPP | Completed | No outcome recorded |
| Phase 2 | NCT01014520 | May 2009 → Feb 2010 | vertebral column disorder | Tabriz University | Unknown | No outcome recorded |
| Phase 2 | NCT00000793 | ? → Oct 1997 | HIV infectious disease, peripheral nervous system disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00029497 | ? → Jun 2004 | carpal tunnel syndrome, occupational disorder | National Center for Complementary and Integrative Health (NCCIH) | 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT02014363 Comparator | Oct 2013 → Oct 2015 | major depressive disorder | e-Therapeutics PLC | Completed | No outcome recorded |
| Phase 2 | NCT01306708 Comparator | Feb → Jul 2011 | frozen shoulder | University of Southern Santa Catarina | Completed | No outcome recorded |
| Phase 2 | NCT01309178 Comparator | May 2009 → May 2011 | cystic fibrosis, pneumonia | University Children's Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 2 | NCT00476151 Comparator | Jul 2007 → Apr 2008 | diabetic polyneuropathy, neuralgia | EpiCept Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00475904 Comparator | Jul 2007 → Jun 2008 | postherpetic neuralgia | EpiCept Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00515229 Comparator | Oct 2006 → Jul 2007 | Pseudomonas aeruginosa infectious disease, cystic fibrosis | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 2 | NCT00497562 Background | May 2004 → Nov 2005 | fibromyalgia, pituitary deficiency | Centro Medico Teknon | Completed | 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 3 | NCT02139098 Comparator | May 2014 → Nov 2017 | insomnia | Philipps University Marburg | Terminated | No outcome recorded |
| Phase 3 | NCT01581281 Comparator | Jun 2012 → Apr 2015 | migraine disorder | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded |
| Phase 3 | NCT01357031 Comparator | May 2010 → Dec 2011 | migraine disorder | Hospital Israelita Albert Einstein | Completed | No outcome recorded |
| Phase 3 | NCT00740571 Comparator | Sep 2008 → Jun 2010 | cancer, neuralgia | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00389038 Comparator | Oct 2006 → Aug 2012 | headache disorder | Children's Hospital Medical Center, Cincinnati | Unknown | No outcome recorded |
| Phase 3 | NCT00351910 Background | May 2006 → Apr 2007 | major depressive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00312260 Comparator | Apr 2006 → May 2010 | — | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 3 | NCT00124306 Comparator | Feb 2005 → Apr 2008 | interstitial cystitis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT01049347 Comparator | Oct 1997 → May 2000 | major depressive disorder | Central Institute of Mental Health, Mannheim | 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 4 | NCT02256943 Comparator | Nov 2014 → May 2018 | chronic pain syndrome | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 4 | NCT02256956 Comparator | Nov 2014 → May 2018 | chronic pain syndrome | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 4 | NCT02090998 Comparator | May 2014 → Mar 2020 | migraine disorder | Rutgers, The State University of New Jersey | Terminated | No outcome recorded |
| Phase 4 | NCT01869907 Comparator | Sep 2011 → Aug 2014 | radiculopathy | Ziekenhuis Oost-Limburg | Completed | No outcome recorded |
| Phase 4 | NCT00766350 Comparator | Nov 2008 → Mar 2010 | fibromyalgia | University of Granada | Completed | No outcome recorded |
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | 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 |
| — | NCT04750967 Comparator | Apr 2021 → Jan 2022 | migraine disorder | Dr. Lutfi Kirdar Kartal Training and Research Hospital | Completed | No outcome recorded |
| — | NCT02746250 Comparator | Mar 2016 → Jan 2017 | — | Danish Headache Center | Completed | No outcome recorded |
| — | NCT02101892 Comparator | Apr 2014 → Feb 2016 | migraine disorder | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT01566825 Comparator | Aug 2008 → May 2009 | — | Dieter Kunz, MD | Completed | No outcome recorded |
| — | NCT01161017 Comparator | Jul 2008 → May 2014 | migraine disorder | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT00325000 Background | Nov 2000 → Aug 2004 | major depressive disorder | German Research Foundation | Terminated | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 111 sources stand behind the page.
| Field | Value | Cited 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 amitriptyline” NCT04689984 ↗ “Gabapentin, pregabalin, or amitriptyline” NCT04689971 ↗ “Amitriptyline Hydrochloride” NCT07296770 ↗ “* Amitriptyline” NCT07016451 ↗ |
| 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 ↗ |
| 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 ↗ |