CLINICAL TRIALS PROFILE FOR HISTAMINE

505(b)(2) Clinical Trials for HISTAMINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC	NCT01537471 ↗	The Effects of Antihistamines on Pre-Pulse Inhibition	Completed	Wallace H. Coulter Foundation	Phase 1	2012-01-01	The purpose of the investigators research is to test whether problems people have with processing their senses (feeling overwhelmed, distracted or upset by sounds and other stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines, which are medicines used for things like allergies, sleep problems, or the common cold.

All Clinical Trials for HISTAMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003991 ↗	Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia	Completed	Maxim Pharmaceuticals	Phase 3	1998-07-01	RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission. PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy.
NCT00004316 ↗	Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis	Completed	University of Pittsburgh	Phase 1/Phase 2	1995-06-01	OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
NCT00004316 ↗	Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/Phase 2	1995-06-01	OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

Clinical Trial Conditions for HISTAMINE

Condition Name

Condition Name for HISTAMINE
Intervention	Trials
Asthma	22
Allergic Rhinitis	17
Itch	8

Condition MeSH

Condition MeSH for HISTAMINE
Intervention	Trials
Rhinitis	30
Rhinitis, Allergic	28
Asthma	18

Clinical Trial Locations for HISTAMINE

Trials by Country

Trials by Country for HISTAMINE
Location	Trials
United States	210
Canada	32
United Kingdom	22
Belgium	19
Germany	17

Trials by US State

Trials by US State for HISTAMINE
Location	Trials
New York	21
Illinois	13
Texas	13
North Carolina	12
Florida	11

Clinical Trial Progress for HISTAMINE

Clinical Trial Phase

Clinical Trial Phase for HISTAMINE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for HISTAMINE
Clinical Trial Phase	Trials
Completed	169
Recruiting	49
Unknown status	25

Clinical Trial Sponsors for HISTAMINE

Sponsor Name

Sponsor Name for HISTAMINE
Sponsor	Trials
GlaxoSmithKline	11
Aalborg University	11
Sanofi	5

Sponsor Type

Sponsor Type for HISTAMINE
Sponsor	Trials
Other	319
Industry	110
NIH	23

Last updated: April 25, 2026

Histamine Drug: What Do Clinical Trials, Market Data, and Projections Show?

Is there enough public clinical-trial signal for “histamine” as a drug?

No. “Histamine” is widely used as a pharmacologic reference substance and as a biologic mediator in basic and translational research, but the term does not map cleanly to a single, regulated, branded therapeutic product with a consistent development pipeline. Public clinical trial registries list histamine under multiple contexts (diagnostics, pharmacology challenges, biologics research tools), and those records do not consolidate into one development program that supports a drug-specific clinical-trials update.

Which indication-level “histamine” programs exist in public development?

Public records are fragmented across uses that are not directly comparable as a therapeutic “histamine drug” thesis. Common buckets include:

• Diagnostic or physiological challenge studies using histamine to probe airway reactivity, gastric function, or immune responses.
• Formulation or delivery research (e.g., local delivery, controlled release, stability) that does not translate into one dominant late-stage therapeutic claim.
• Histamine-pathway agents (H1 antagonists, H2 antagonists, mast-cell stabilizers, anti-IgE, anti-cytokine drugs) that are frequently confused in business discussions with “histamine” itself, but they are separate drug classes with their own regulatory and IP trajectories.

Because the development taxonomy is not consistent, an “indication-agnostic” clinical update for “histamine” cannot be stated as a single drug narrative without producing incorrect or misleading signal.

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Market Analysis: What market can be attributed to “histamine” as a drug?

What is the commercial market for histamine itself?

Commercial market reporting for “histamine” typically falls into:

• Laboratory/diagnostic reagent markets
• Used-in-study supply
• Specialized formulations for research or limited clinical use

It does not show the structure needed for a standard market forecast (addressable patient population, treatable indication, reimbursed regimen, and standard-of-care comparators) that investors and R&D teams require for projections.

How do industry “histamine” numbers usually get misread?

Market discussions often blend three distinct categories:

• Histamine molecule (active mediator or reagent)
• Histamine receptor antagonists (H1, H2)
• Upstream allergy and mast-cell pathway therapies

These categories trade on different prescriber behavior, different regulatory pathways, and different IP landscapes. Without an explicit, branded, indication-specific product identity, “histamine market” numbers do not support a defensible forecast.

Comparable market benchmarks are not applicable

A defensible projection requires:

• A defined drug identity (brand or INN with clear formulation)
• A defined indication and line of therapy
• A defined trial-to-approval path and label assumptions

Public data for “histamine” does not anchor to one such pathway.

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Projections: Can a credible revenue and adoption forecast be built?

What can be projected for “histamine” given the absence of a definable development program?

A credible projection cannot be produced because:

• There is no single, publicly consistent late-stage development track for “histamine” as one therapeutic product.
• The term “histamine” does not identify a stable, reimbursed clinical regimen.
• Market sizing databases do not consistently classify “histamine” as a standalone therapeutic market the way they do for receptor antagonists or pathway inhibitors.

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Clinical Trials Update Framework (for “histamine” specifically): What is measurable right now?

What trial endpoints are typically tracked for histamine studies?

Trials involving histamine commonly focus on:

• Physiologic responsiveness (bronchoprovocation thresholds, gastric acid secretion response)
• Safety tolerability of administration (dose-limiting reactions, systemic effects)
• Biomarker shifts (histamine-mediated signaling readouts)

Those endpoints are common in translational and challenge settings. They are not enough to infer a therapeutic label and therefore do not support commercialization-grade adoption models.

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Investment and R&D Implications: What do business teams do with this?

What is the actionable bottom line?

• Treat “histamine” as a platform molecule/research mediator rather than a single, investable therapeutic program unless and until it is tied to an explicit branded product or INN with a defined therapeutic indication.
• For strategy work, re-map the request to histamine-pathway drugs (H1/H2 receptor antagonists, mast-cell targeting, allergy biologics) if the goal is a forecastable revenue model.
• If the internal objective is “histamine replacement therapy” or “histamine agonism,” the development program must be tied to a specific formulation and claim; generic “histamine” will not support a reliable clinical and market view.

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Key Takeaways

1. “Histamine” as a drug term does not resolve to one coherent therapeutic development program suitable for a clinical trials update.
2. Market reporting for “histamine” is generally dominated by reagent or specialized uses, not a standard reimbursed therapeutic market that supports projections.
3. Revenue and adoption forecasts require an indication-specific, product-specific identity that the generic “histamine” label does not provide.

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FAQs

1. Is histamine being developed as a standalone therapeutic in late-stage trials?
   No single late-stage, indication-consistent “histamine” program is discernible from public trial records under that generic label.

2. What’s the main confusion when people ask about the “histamine market”?
   They often mix histamine the mediator with histamine receptor antagonists and mast-cell pathway therapies.

3. Do clinical histamine studies count as drug development?
   They often function as diagnostic or physiologic challenge studies and do not reliably translate into a therapeutic regulatory pathway.

4. Can a forecast be built without an indication and branded product identity?
   Not in a defensible way; standard market forecast inputs depend on a defined label and regimen.

5. What category should investors look at if they want histamine-related commercialization?
   Histamine-pathway drugs (H1/H2 receptor antagonists, anti-allergy and mast-cell pathway therapies) where indication and market structure are established.

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References

[1] ClinicalTrials.gov. “Histamine” results. U.S. National Library of Medicine. https://clinicaltrials.gov/
[2] WHO. ATC/DDD Index. World Health Organization. https://www.whocc.no/atc_ddd_index/
[3] FDA. Drug Development and Approval Process (overview of review pathways and labeling concepts). U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs