Drugs / Nortriptyline
Nortriptyline
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PAMELOR | — | 1978-06-29 – 1982-02-18 | fda.gov ↗ |
| Approved | US (FDA) | AVENTYL HYDROCHLORIDE | — | 1964-11-06 | fda.gov ↗ |
Trials 33
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02881125 | Nov 2016 → Jan 2018 | small cell carcinoma | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT00721331 | Jul → Sep 2008 | atopic eczema | Zalicus | Completed | No outcome recorded |
| Phase 1 | NCT00544687 | Sep → Nov 2007 | — | Zalicus | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT00742573 | Aug 2008 → Jan 2014 | major depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00557739 | Nov 2007 → Jan 2008 | psoriasis | Zalicus | Completed | No outcome recorded |
| Phase 2 | NCT00062738 | Jun 2003 → Jan 2009 | Parkinson disease, depressive disorder | Rutgers, The State University of New Jersey | Completed | Mixed |
| Phase 2 | NCT00066937 | Nov 2002 → Jun 2008 | temporomandibular joint disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00009672 | Jan 2001 → Dec 2006 | radiculopathy, sciatica | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00018148 | Apr 1998 → Dec 2002 | — | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT03652571 | Sep 2018 → Aug 2024 | dyspepsia | Maastricht University Medical Center | Terminated | Missed primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01065649 | Jan → Jun 2010 | gastroesophageal reflux disease | Universidade de Passo Fundo | Completed | No outcome recorded |
| Phase 3 | NCT00004390 | Feb 1995 → ? | postherpetic neuralgia | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 416 trials · 1 met primary | ||||||
| Phase 4 | NCT07856056 | May 2027 → May 2030 expected | migraine disorder | Sultan Qaboos University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07795593 | Oct 2026 → May 2031 expected | diabetic kidney disease, diabetic neuropathy | University of Michigan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05582837 | Aug 2022 → Dec 2027 expected | Meniere disease | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 4 | NCT04226365 | Feb 2020 → May 2023 | traumatic brain injury, traumatic encephalopathy | Lancaster General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04404439 | Sep 2019 → Dec 2023 | tinnitus | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT05531591 | Aug 2019 → Jul 2024 | cognitive impairment with or without cerebellar ataxia, dementia, major depressive disorder | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 4 | NCT03548675 | May 2018 → Feb 2022 | major depressive disorder | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02960763 | Feb 2017 → Sep 2020 | major depressive disorder | Washington University School of Medicine | Completed | Mixed |
| Phase 4 | NCT02260388 | Oct 2014 → Sep 2017 | idiopathic progressive polyneuropathy | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02237937 | Sep 2011 → Dec 2014 | major depressive disorder | HolsboerMaschmeyer NeuroChemie GmbH | Unknown | No outcome recorded |
| Phase 4 | NCT02918097 | May 2010 → Nov 2014 | bipolar disorder | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| Phase 4 | NCT02901249 | May 2010 → Nov 2014 | major depressive disorder | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| Phase 4 | NCT00118430 | Sep 2004 → Jul 2008 | depressive disorder | Indiana University | Completed | Met primary |
| Phase 4 | NCT00021528 | Jul 2001 → Sep 2006 | major depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT00045916 | Feb 2001 → Dec 2006 | bipolar disorder, depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00000375 | Feb 1997 → ? | major depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT00386243 | Dec 2007 → May 2012 | chronic pain syndrome | VA Office of Research and Development | Completed | Met primary |
| — | NCT01352572 | Jan 2002 → Dec 2018 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT01352559 | Nov 2001 → Mar 2007 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT00000377 | Mar 1989 → Apr 2000 | depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1/2 | NCT00612807 Background | Jul 2006 → Jun 2010 | major depressive disorder | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT03844412 Comparator | Nov 2019 → Mar 2024 | endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome +4 | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT00796211 Comparator | Nov → Dec 2008 | psoriasis | Zalicus | Completed | No outcome recorded |
| Phase 2 | NCT01268709 Comparator | — | irritable bowel syndrome | Qom University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT00539240 Comparator | Apr 2006 → Apr 2010 | gastroesophageal reflux disease | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03652870 Comparator | Mar 2021 → Jan 2023 | Parkinson disease, depressive disorder | University College, London | Completed | No outcome recorded |
| Phase 3 | NCT00765895 Comparator | Jan 2009 → Oct 2012 | idiopathic gastroparesis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 4 | NCT07655440 Comparator | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06799169 Comparator | Jun 2025 → Dec 2026 expected | tinnitus | University of California, Irvine | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00660062 Comparator | Aug 2009 → Nov 2014 | major depressive disorder | Hillerod Hospital, Denmark | Terminated | Missed primary |
| Phase 4 | NCT01305707 Comparator | Jul 2009 → Jul 2014 | major depressive disorder | Hospital Universitari de Bellvitge | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01476930 Comparator | Jun 2008 → Sep 2009 | migraine disorder | Birjand University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00251732 Comparator | Mar 2005 → May 2010 | gastroesophageal reflux disease | University of Arizona | Completed | No outcome recorded |
| Phase 4 | NCT00000378 Comparator | Jul 1997 → Jun 2002 | major depressive disorder, melancholia | New York State Psychiatric Institute | Completed | No outcome recorded |
| — | NCT02169830 Comparator | Aug 2014 → Oct 2019 | migraine disorder | St. Louis University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01943435 Comparator | Nov 2013 → Jun 2016 | lumbar spinal stenosis | Michael Schneider, DC, PhD | Completed | No outcome recorded |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT00547703 Comparator | Feb 2008 → Apr 2010 | dyspepsia | The Cleveland Clinic | Terminated | No outcome recorded |
| — | NCT00564278 Background | Feb 2008 → Aug 2013 | depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| — | NCT00817011 Comparator | Apr 2006 → Dec 2016 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT00817375 Comparator | Feb 2003 → Dec 2018 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT01228357 Comparator | Feb 2003 → Dec 2018 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-02-25 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from USFDA for Nortriptyline Hydrochloride Capsules zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Nortriptyline Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg and 75 mg (US RLD: Pamelor Capsules). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-02-25 | Zydus Lifesciences Limited | Zydus Cadila receives final approval from USFDA for Nortriptyline Hydrochloride Capsules zyduslife.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nortriptyline | “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗52“Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.” NCT00742573 ↗ “Patients were treated with the TCAs nortriptyline, clomipramine, or imipramine, with clinical follow-up of 7 weeks.” PMID 37155164 ↗ May 2023 “non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine” NCT00817375 ↗ “Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms” NCT00018148 ↗ “Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine” NCT01943435 ↗ “Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline” NCT07795593 ↗ “nortriptyline ,propranolol ,ergotamine , sumatriptan tablets” NCT01476930 ↗ “low dose tricyclic antidepressant (nortriptyline 50mg)” NCT00539240 ↗ “Nortriptyline, start at 10-25, titrate to 100 mg” NCT00386243 ↗ “nortriptyline (25 mg, increased to 50 to 75 mg)” NCT00118430 ↗ |
| Known as | Aventyl | “nortriptyline_Aventyl, Pamelor, Noritren” NCT00817011 ↗ |
| Known as | Noritren | “nortriptyline_Aventyl, Pamelor, Noritren” NCT00817011 ↗ |
| Known as | nortriptyline HCl | “CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)” NCT00544687 ↗ |
| Known as | Nortriptyline Hydrochloride | “Nortriptyline Hydrochloride” NCT07296770 ↗ |
| Known as | Pamelor | “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗1“nortriptyline_Aventyl, Pamelor, Noritren” NCT00817011 ↗ |
| Action | Inhibit | “Nortriptyline is a metabolite of amitriptyline. However, unlike amitriptyline it has mainly noradrenergic effects, and weakly blocks dopaminergic reuptake.” NCT03652870 ↗ |
| Modality | Small molecule | “a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms” NCT00018148 ↗ |
| Route | Oral | “Patients start with nortriptyline, morphine, or placebo, taken orally every day.” NCT00004390 ↗ |