Drugs / Doxepin
Doxepin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DOXEPIN HYDROCHLORIDE | — | 1975-04-28 | fda.gov ↗ |
| Approved | US (FDA) | SINEQUAN | — | 1969-09-23 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01489982 | Jan 2011 → Dec 2012 | Parkinson disease, insomnia | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02062632 | Apr 2014 → May 2015 | carcinoma of esophagus, hypopharyngeal carcinoma, laryngeal carcinoma, lymphoma +9 | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00755495 | Jul 2006 → Mar 2007 | sleep disorder, initiating and maintaining sleep | Takeda | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05115136 | May 2022 → Jan 2023 | urticaria | State University of New York - Upstate Medical University | 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 | NCT02229539 | Nov 2014 → May 2016 | mucositis | Alliance for Clinical Trials in Oncology | Completed | Met primary |
| Phase 3 | NCT01156142 | Dec 2010 → May 2012 | head and neck cancer, stomatitis | Alliance for Clinical Trials in Oncology | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07598734 | Jun 2026 → Jun 2028 expected | — | University of Washington | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07542756 | May 2026 → Jan 2032 expected | insomnia | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06017895 | Oct 2023 → Jul 2026 overdue | — | Nanfang Hospital, Southern Medical University | Recruiting | No outcome recorded |
| — | NCT04554888 | Mar → May 2022 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT04588532 | Oct 2020 → May 2021 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT03943407 | Nov 2019 → Jun 2021 | — | Aalborg University | Withdrawn | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT02447211 Comparator | May 2015 → Jan 2019 | breast cancer | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT01268709 Comparator | — | irritable bowel syndrome | Qom University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT03758079 Comparator | Jun → Oct 2018 | — | University of Balamand | Completed | No outcome recorded |
| Phase 4 | NCT00465972 Comparator | Mar 2007 → Aug 2010 | HIV infectious disease, insomnia | Duke University | Completed | No outcome recorded |
| — | NCT05107999 Comparator | Feb 2021 → Aug 2022 | dyspepsia, physiological malfunction arising from mental factor | RenJi Hospital | Unknown | Met primary |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Doxepin | “The anti-histamine cream Prudoxin, containing 5% doxepin hydrochloride (1 g contains 50 mg of doxepin) (Healthpoint, San Antonio, TX) will be applied on the volar forearm.” NCT03943407 ↗17“Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length” NCT00465972 ↗ |
| Known as | desipramine | “this will either be a medication called desipramine (also called Doxepin), or zopiclone (also called Imovane).” NCT01489982 ↗ |
| Known as | doxepin hydrochloride | “Drug: Doxepin Hydrochloride (Doxepin)” NCT05107999 ↗1“doxepin (doxepin hydrochloride)” NCT02062632 ↗ |
| Known as | Prudoxin | “The anti-histamine cream Prudoxin, containing 5% doxepin hydrochloride (1 g contains 50 mg of doxepin) (Healthpoint, San Antonio, TX) will be applied on the volar forearm.” NCT03943407 ↗ |
| Action | Inhibit | “Doxepin is a tricyclic antidepressant that has been shown to have much higher concentrations of histamine blocking activity” NCT05115136 ↗ |
| Route | Oral | “Doxepin 10 mg po nightly x duration of study length” NCT00465972 ↗ |