Diphenhydramine
Small molecule targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BENADRYL | — | 1984-08-30 | fda.gov ↗ |
| Approved | US (FDA) | BENADRYL | — | 1946-03-04 | fda.gov ↗ |
Trials 56
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02142543 | Mar → Dec 2012 | aphthous stomatitis | Texas A&M University | Completed | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT04741139 | Sep 2021 → Dec 2022 | autoimmune thrombocytopenia | Baylor College of Medicine | Unknown | No outcome recorded |
| Phase 1 | NCT04093271 | Sep → Dec 2019 | — | LifeSeasons Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03424135 | Mar → Apr 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03396250 | Feb → Mar 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02476058 | Jun 2015 → Jan 2016 | major depressive disorder | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT01965301 | Oct 2014 | — | Bioprojet | Terminated | No outcome recorded |
| Phase 1 | NCT01737931 | Aug → Oct 2012 | — | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00762749 | Sep → Nov 2008 | allergic rhinitis | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 1 | NCT00240123 | Jul 2005 → Jul 2007 | gallbladder disorder, gallstones, hyperbilirubinemia, pancreatitis | University of Rochester | Withdrawn | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 28 trials | ||||||
| Phase 2 | NCT07358689 | Jun 2026 → Jan 2028 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05501678 | Aug 2023 → Dec 2027 expected | autism | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT04846348 | Jul → Sep 2021 | cutaneous mastocytosis | Joseph Butterfield | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02671760 | Feb → Jun 2016 | insomnia | Sequential Medicine Ltd | Completed | No outcome recorded |
| Phase 2 | NCT02142712 | Dec 2014 | brain edema, stroke disorder | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT00837941 | Apr → Aug 2009 | diabetic polyneuropathy | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT00590590 | Oct 2007 → Jun 2009 | vulvodynia | Lumara Health, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00429702 | Oct 2007 → Aug 2009 | childhood malignant neoplasm | University of South Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06702670 | Mar 2025 → Mar 2027 expected | dystocia | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 313 trials · 2 missed | ||||||
| Phase 3 | NCT06910241 | Sep 2025 → Jun 2027 expected | — | Florida Atlantic University | Recruiting | No outcome recorded |
| Phase 3 | NCT06704620 | Dec 2024 → Nov 2026 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06819774 | Apr 2024 → Aug 2025 overdue | urticaria | Shandong New Time Pharmaceutical Co., LTD | Recruiting | No outcome recorded |
| Phase 3 | NCT03338764 | May → Dec 2023 | insomnia | Sequential Medicine Ltd | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04175834 | Feb 2020 → May 2022 | multiple sclerosis | Providence Health & Services | Completed | No outcome recorded |
| Phase 3 | NCT03331042 | Oct 2017 → Mar 2018 | insomnia | Sequential Medicine Ltd | Completed | 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 | NCT01888497 | Jul → Dec 2013 | — | Viatris Inc. | Completed | Missed primary |
| Phase 3 | NCT01495858 | Dec 2011 → Feb 2012 | — | Bayer | Completed | Missed primary |
| Phase 3 | NCT01177852 | Oct 2011 → Apr 2012 | rhinitis | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01199497 | Aug 2011 → Aug 2012 | nasal cavity disorder | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01365052 | May → Jul 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00814359 | May 2009 → Sep 2010 | head and neck cancer, mucositis | Juravinski Cancer Centre Foundation | Completed | No outcome recorded |
| Phase 415 trials · 2 met primary | ||||||
| Phase 4 | NCT07542756 | May 2026 → Jan 2032 expected | insomnia | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 4 | NCT07542730 | May 2026 → Feb 2027 expected | anxiety | University of Rochester | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06819033 | Mar 2025 → Feb 2026 overdue | aphthous stomatitis | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 4 | NCT06217367 | Dec 2023 → Jun 2024 | allergic rhinitis, dysautonomia-like disorder | Lakehead University | Unknown | No outcome recorded |
| Phase 4 | NCT05586477 | Nov 2022 → Jun 2023 | allergic rhinitis | Lakehead University | Completed | No outcome recorded |
| Phase 4 | NCT05219604 | Mar → Oct 2022 | — | Dent Neuroscience Research Center | Terminated | No outcome recorded |
| Phase 4 | NCT04255420 | Feb 2020 → May 2021 | headache disorder | Kendall Healthcare Group, Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT03490396 | May 2018 → Nov 2019 | chemotherapy-induced oral mucositis | Midatech Pharma US Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02463929 | Apr → Jun 2014 | — | Universitas Diponegoro | Completed | No outcome recorded |
| Phase 4 | NCT02062710 | Jan → Jun 2014 | — | Montefiore Medical Center | Completed | Met primary |
| Phase 4 | NCT01967433 | Dec 2013 → Mar 2018 | — | University of Oklahoma | Completed | No outcome recorded |
| Phase 4 | NCT02578186 | Nov 2013 → Dec 2014 | insomnia | Procter and Gamble | Completed | Met primary |
| Phase 4 | NCT00638443 | Mar 2008 → Mar 2010 | lumbar spinal stenosis | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT00937924 | Feb 2008 → Jun 2012 | — | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT00648973 | Nov 2006 → May 2007 | nasal cavity disorder | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07285031 | Dec 2025 → Aug 2026 overdue | — | University of British Columbia | Recruiting | No outcome recorded |
| — | NCT05036174 | Sep 2021 → Apr 2022 | osteoarthritis, knee | Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology | Unknown | No outcome recorded |
| — | NCT04700007 | Jan → Dec 2021 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT01556932 | Mar 2012 → May 2013 | — | Virginia Commonwealth University | Completed | No outcome recorded |
| — | NCT01321021 | Mar → Jul 2011 | — | University of Basel | Completed | No outcome recorded |
| — | NCT01204255 | Nov 2010 → Apr 2011 | — | Virginia Commonwealth University | Completed | No outcome recorded |
| — | NCT01067677 | Feb 2010 → Feb 2012 | — | Franklyn Cladis | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00961792 | Mar 2004 → Sep 2026 overdue | alcohol dependence | University of Chicago | Active not recruiting | No outcome recorded |
| Comparator or background therapy173 trials | ||||||
| Phase 0 | NCT05013437 Background | Sep → Dec 2023 | plasma cell myeloma | Koen van Besien | Withdrawn | No outcome recorded |
| Phase 0 | NCT03688464 Comparator | Feb 2019 | atopic eczema | University of Nebraska | Withdrawn | No outcome recorded |
| Phase 1 | NCT06070649 Comparator | Aug 2025 → Aug 2027 expected | alcohol-related disorders | Yale University | Recruiting | No outcome recorded |
| Phase 1 | NCT05729555 Comparator | Apr → Oct 2023 | insomnia | Overseas Pharmaceuticals, Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05211336 Background | Apr 2022 → Jun 2024 overdue | diffuse large B-cell lymphoma of the central nervous system | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Show all 173 trials opens the full record — a long page | ||||||
Evidence & citations 44 cited values
Every value below carries the sentence it was read from. 232 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diphenhydramine | “Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions:...” NCT07252739 ↗216“Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related...” NCT07227597 ↗ “Before the use of utidelone, all patients will accept pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and...” NCT05866510 ↗ “Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.” NCT04548999 ↗ “The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604212 ↗ “Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.” NCT01495858 ↗ “An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.” NCT00719472 ↗ “Antihistamine (e.g., diphenhydramine) or equivalent medications per institutional standard may be administered at the discretion of the investigator.” NCT03258593 ↗ “Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.” NCT00346151 ↗ “An antihistamine (e.g., IV diphenhydramine \[1 mg/kg, 50 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab” NCT04743661 ↗ “3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.” NCT03331042 ↗ |
| Known as | Antitussive | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Beldin | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Belix | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Benadryl | “reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)” NCT05729555 ↗13“Benadryl 25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.” NCT01392183 ↗ “The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.” NCT02300727 ↗ “diphenhydramine, a first-generation antihistamine sold commercially as Benadryl®.” NCT05586477 ↗ “Oral Diphenhydramine (Benadryl), 25 mg” NCT03968939 ↗ “Diphenhydramine (Benadryl)” NCT00137202 ↗ “diphenhydramine (Benadryl)” NCT03456817 ↗ |
| Known as | Benadryl preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Benylin | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Caladryl | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Coltex | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | DHP HCL | “naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules” NCT03424135 ↗ |
| Known as | Dibenil | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Difenhidramina | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Diphen | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Diphenhdyra | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Diphenhydramin | “Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.” NCT04700007 ↗ |
| Known as | Diphenhydramine citrate | “Ibuprofen 400 mg / Diphenhydramine citrate 76 mg” NCT01118273 ↗ |
| Known as | diphenhydramine HCl | “A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule” NCT00762749 ↗4“Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.” NCT05627557 ↗ “Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.” NCT05039619 ↗ “2 x Diphenhydramine HCl 25 mg under fasting conditions” NCT01666678 ↗ |
| Known as | Diphenhydramine hydrochloride | “To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and...” NCT03396250 ↗10“Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by...” NCT02578186 ↗ “The primary purpose of the present study was to examine whether diphenhydramine hydrochloride (DPH), a first-generation antihistamine, affects the sweating, core temperature,...” PMID 39140777 ↗ Jul 2024 “The subjects received 1 ml of the injection of Diphenhydramine Hydrochloride (for deep intramuscular injection) and 1 ml of the injection of Simulated Cetirizine Hydrochloride...” NCT06819774 ↗ “Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.” NCT01495858 ↗ “50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion” NCT01382940 ↗ “Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.” NCT01118273 ↗ “reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)” NCT05729555 ↗ “Drug: Diphenhydramine Hydrochloride” NCT05627557 ↗ |
| Known as | Diphenhydramine hydrochloride component of benylin | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Diphenhydramine hydrochloride preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | DPH | “The primary purpose of the present study was to examine whether diphenhydramine hydrochloride (DPH), a first-generation antihistamine, affects the sweating, core temperature,...” PMID 39140777 ↗ Jul 20244“The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo” NCT01365052 ↗ “Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.” NCT01495858 ↗ “Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.” NCT01118273 ↗ “novel combination naproxen sodium (NS) and diphenhydramine (DPH)” PMID 25996289 ↗ May 2015 |
| Known as | DPH HCl | “To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and...” NCT03396250 ↗ |
| Known as | Dreemon | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Fedril | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Gppe cough expect paed | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Gppe oral soln | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Histergan | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Hydramine | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Medinex | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Nightcalm | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | NSC-33299 | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Nytol | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Nytol one-a-night | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Paxidorm | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Restamin | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Restamine | “Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.” NCT04700007 ↗ |
| Known as | Silphen | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Sleepia | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Tixylix catarrh | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Known as | Vicks formula 44 | ChEMBL registry synonym — accepted as the source's own label CHEMBL657 ↗ |
| Action | Inhibit | “the histamine H1 receptor antagonist diphenhydramine” NCT01321021 ↗1“Histamine H1 receptor antagonist” CHEMBL657 ↗ |
| Modality | Small molecule | — CHEMBL657 ↗ |
| Route | Intravenous | “50 mg intravenously 30-60 minutes prior to Ixabepilone (BMS-247550)” NCT00030992 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL657 ↗ |