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 · a red edge is where a trial was stopped

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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Phase 1/2 NCT01324960 Mar 2011 → Dec 2014 myelodysplastic syndrome Groupe Francophone des Myelodysplasies Withdrawn No outcome recorded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
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
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 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.

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

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

NCT01719133

NCT01777464

NCT04700007

NCT04588532

NCT04554888

NCT01925729

NCT01689363

NCT04058054

NCT04115462

NCT01963741

NCT04676763

NCT01937494

NCT04076865

NCT01292070

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

NCT00005038

NCT05810792

NCT00039234

NCT01347996

NCT00003991

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