Histamine
Small molecule targets HRH1 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ceplene | — | 2008-10-07 | europa.eu ↗ |
| Approved | US (FDA) | HISTAMINE PHOSPHATE | — | 1939-04-25 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02889159 | Jun 2016 → Feb 2023 | skin disorder | University of Michigan | Completed | No outcome recorded |
| Phase 1 | NCT01925729 | Oct 2013 → Mar 2019 | allergic rhinitis, otitis media | Cuneyt M. Alper | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03040401 | Feb 2017 → Dec 2018 | chronic myelomonocytic leukemia | Vastra Gotaland Region | Unknown | No outcome recorded |
| Phase 1/2 | NCT01324960 | Mar 2011 → Dec 2014 | myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Withdrawn | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05810792 | Apr 2024 → Apr 2027 expected | malignant pancreatic neoplasm, metastatic neoplasm | Sahlgrenska University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT00005038 | Jun 1999 → ? | renal cell carcinoma | The Christie NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00039234 | Sep 2002 → ? | cutaneous melanoma, metastatic malignant neoplasm | Maxim Pharmaceuticals | Unknown | No outcome recorded |
| Phase 3 | NCT00003991 | Jul 1998 → Aug 2011 | leukemia | Maxim Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01347996 | Jul 2009 → Jun 2014 | acute myeloid leukemia | Cytovia, Inc. | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT04554888 | Mar → May 2022 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT04700007 | Jan → Dec 2021 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT04588532 | Oct 2020 → May 2021 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT01937494 | May 2013 → May 2014 | asthma | Centre Hospitalier Universitaire Saint Pierre | Completed | No outcome recorded |
| — | NCT01777464 | Nov 2012 → Feb 2016 | house allergic alveolitis | Universitaire Ziekenhuizen KU Leuven | Terminated | No outcome recorded |
| — | NCT01963741 | Nov 2012 → Feb 2014 | allergic rhinitis, asthma | Guangzhou Institute of Respiratory Disease | Completed | No outcome recorded |
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01292070 Background | Mar → Apr 2011 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01567319 Background | Feb → Nov 2012 | allergic disease | Roxall Medicina España S.A | Completed | No outcome recorded |
| Phase 1 | NCT01204866 Background | Jul → Aug 2010 | allergic disease | PharmAthene, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01719133 Background | Feb → Mar 2008 | allergic rhinitis | Anergis | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01689363 Comparator | Sep → Nov 2012 | hypersensitivity reaction disease | Amphastar Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01597752 Background | Apr → Sep 2012 | — | Laboratorios Leti, S.L. | Completed | No outcome recorded |
| Phase 2 | NCT01430117 Background | Oct 2011 → Feb 2012 | allergic disease | Laboratorios Leti, S.L. | Completed | No outcome recorded |
| Phase 2 | NCT01408238 Background | Oct 2011 → Mar 2012 | allergic disease | Laboratorios Leti, S.L. | Completed | No outcome recorded |
| Phase 2 | NCT01407835 Background | Oct 2011 → Mar 2012 | allergic disease | Laboratorios Leti, S.L. | Completed | No outcome recorded |
| Phase 2 | NCT00866437 Background | Apr 2009 → May 2010 | premenstrual tension | EVE Medical Systems Ltd. | Unknown | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT04676763 Background | Mar → Jul 2021 | skin disorder | GlaxoSmithKline | Completed | No outcome recorded |
| — | NCT04115462 Comparator | Jan → May 2020 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT04076865 Background | Oct 2019 → Oct 2020 | — | Aalborg University | Completed | No outcome recorded |
| — | NCT04058054 Comparator | Jul → Aug 2019 | hypersensitivity reaction disease | KeraNetics, LLC | Completed | No outcome recorded |
| — | NCT00937196 Comparator | Aug 2006 → Mar 2007 | hypertensive disorder | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Histamine | “10 mg/ml histamine dihydrochloride solution” NCT01597752 ↗ |
| Known as | .beta.-aminoethylglyoxaline | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | Allergen scratch extract positive control 'torii' histamine dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | Ceplene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01324960 ↗ |
| Known as | Ergamine | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | Ergotidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | HDC | “histamine dihydrochloride (HDC), a NOX2 inhibitor, exerts anti-cancer efficacy in experimental tumor models” PMID 30315349 ↗ Oct 20182“histamine dihydrochloride (HDC; Ceplene®)” NCT03040401 ↗ “Histamine Dihydrochloride (HDC)” NCT05810792 ↗ |
| Known as | HISTAMINE BROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | histamine dihydrochloride | “A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.” NCT04700007 ↗10“using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively” NCT01430117 ↗ “using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively” NCT01408238 ↗ “using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively” NCT01567319 ↗ “10 mg/ml histamine dihydrochloride solution” NCT01407835 ↗ “histamine dihydrochloride (HDC; Ceplene®)” NCT03040401 ↗ |
| Known as | Histamine dihydrocloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | HISTAMINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | histamine phosphate | “7. Histamine phosphate 1mg/ml (epicutaneous- prick test)” NCT00866437 ↗ |
| Known as | Histaminum hydrochloricum | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00937196 ↗ |
| Known as | Maxamine | “histamine dihydrochloride (Maxamine)” NCT00003991 ↗ |
| Known as | NSC-257873 | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | NSC-33792 | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Known as | Peremin | ChEMBL registry synonym — accepted as the source's own label CHEMBL90 ↗ |
| Action | Activate | “The HDC component of the immunotherapy exerts agonist activity at histamine type 2 receptors (H2Rs)” PMID 28235771 ↗ Feb 20171“Histamine H1 receptor agonist” CHEMBL90 ↗ |
| Modality | Small molecule | — CHEMBL90 ↗ |
| Route | Subcutaneous | “histamine dihydrochloride subcutaneously” NCT00003991 ↗ |
| Target | HRH1 | “Histamine H1 receptor agonist” CHEMBL90 ↗ |