Histamine Phosphate

Sold as Histamine Phosphate. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Histamine Phosphate (sold as Histamine Phosphate), first approved Apr 25, 1939, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 25, 1939
Applications: 1
New uses approved: 0
Complete response letters: 0
First approved in the EU: Oct 7, 2008

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

For use as an adjunct to cytokine therapy in the treatment of malignant melanoma.EpiCept Corporation · designated Feb 1, 2000
Adjunct to cytokine therapy in the treatment of acute myeloid leukemia.EpiCept Corporation · designated Dec 15, 1999

Approvals in the EU (EMA)

First approved in the EU 833 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ceplene, new substanceLaboratoires Delbert · Oct 7, 2008

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Allergen Scratch Extract Positive control “TORII” Histamine dihydrochloride, new approvalA drug with a new indication and a new dosage in a newly-added dosage form indicated for positive control in skin tests when diagnosing allergy. · Japan Tobacco Inc. · Sep 28, 2015 · Review report

Clinical Trials

65 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effect of Oral Diamine Oxidase on Symptoms Induced by Histamine Oral ChallengeHistamine Intolerance, Food Hypersensitivity · DR Healthcare - biotexia	Not applicable	Recruiting	Nov 13, 2026
Effect of Pre-heat Conditioning on Histaminergic ItchITCH, Heat · Aalborg University	Not applicable	Not yet recruiting	Nov 12, 2026
Pain Sensitivity and Pruritus of Peripheral NervesITCH · Aalborg University	Not applicable	Active, not recruiting	Oct 22, 2026
Personalized Probiotic Treatments for Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS) · McMaster University	Not applicable	Enrolling by invitation	Oct 13, 2026
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2Functional Gastrointestinal Disorders · Buddhist Tzu Chi General Hospital	Phase 2	Recruiting	Oct 5, 2026
Apremilast Added to Antihistamines in Chronic UrticariaChronic Urticaria, Chronic Spontaneous Urticaria · Rashid Latif Medical College	Phase 2	Enrolling by invitation	Sep 30, 2026
Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance SymptomsGI Health · Radicle Science	Not applicable	Not yet recruiting	Sep 23, 2026
A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)Advanced Solid Tumors, Malignant Neoplasm · Merck Sharp & Dohme LLC	Phase 2	Recruiting	Aug 25, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Apr 25, 1939	Histamine PhosphateNDA 734	Lilly	1	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA