Drugs / Histamine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 1/2 NCT01324960 Mar 2011 → Dec 2014 myelodysplastic syndrome Groupe Francophone des Myelodysplasies Withdrawn No outcome recorded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
— NCT01963741 Nov 2012 → Feb 2014 allergic rhinitis, asthma Guangzhou Institute of Respiratory Disease Completed No outcome recorded
— NCT01777464 Nov 2012 → Feb 2016 house allergic alveolitis Universitaire Ziekenhuizen KU Leuven Terminated No outcome recorded
Comparator or background therapy15 trials
Phase 0 NCT01292070 Background Mar → Apr 2011 — National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
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 2 NCT01689363 Comparator Sep → Nov 2012 hypersensitivity reaction disease Amphastar Pharmaceuticals, Inc. 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.

FieldValueCited text
Known as histamine “10 mg/ml histamine dihydrochloride solution” NCT01597752 ↗
15

“Histamine (1 mg/mL), positive control” NCT01204866 ↗

NCT01937494 ↗

NCT01777464 ↗

NCT01719133 ↗

NCT01292070 ↗

NCT04700007 ↗

NCT04076865 ↗

NCT04588532 ↗

NCT01925729 ↗

NCT01963741 ↗

Show 5 more sources

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 ↗
1

NCT03040401 ↗

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 2018
2

“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 ↗

NCT00003991 ↗

NCT01347996 ↗

NCT00039234 ↗

NCT05810792 ↗

NCT00005038 ↗

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 ↗
1

NCT02889159 ↗

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 2017
1

“Histamine H1 receptor agonist” CHEMBL90 ↗

Modality Small molecule — CHEMBL90 ↗
Route Subcutaneous “histamine dihydrochloride subcutaneously” NCT00003991 ↗
Target HRH1 “Histamine H1 receptor agonist” CHEMBL90 ↗