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Tripelennamine

Phase 1

Healthy | Small molecule | Other |Atlantic International Corp.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

Tripelennamine · 1 trial · 1 indication

Early Phase 1 1
NCT07778472Topical Tripelennamine 1% Cream Versus Diphenhydramine 1% Cream for the Relief of Histamine-Induced Itching: A Proof Concept Study in Healthy Adults.Healthy
COMPLETED37 Analytics
EARLY_PHASE1COMPLETED
Topical Tripelennamine 1% Cream Versus Diphenhydramine 1% Cream for the Relief of Histamine-Induced Itching: A Proof Concept Study in Healthy Adults.
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Study Endpoints

Primary Endpoints

VAS
Subjects rated their itch intensity every 60 seconds until the itch sensation had completely subsided using a visual analog scale (VAS) for 60 minutes.

The effectiveness of tripelennamine 1% cream compared to diphenhydramine 1% cream in relieving histamine-induced itching was determined using a visual analogue scale for pruritus (VAS) as an endpoint. The following parameters were determined from the VAS itch score vs time curves: area under the curve, peak VAS itch score and duration of itch.

Secondary Endpoints

Histamine Triple Response
Research assistants rated the magnitude of the wheal and flare in 5-minute intervals for up to 20 minutes using a rating of 1-mild, 2-moderate, 3-severe.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vehicle control cream basePLACEBO_COMPARATORParticipants received a single topical application of vehicle cream base prior to histamine iontophoresis to serve as a control condition.
Diphenhydramine 1% topical creamACTIVE_COMPARATORParticipants received a single topical application of diphenhydramine 1% cream prior to histamine iontophoresis to evaluate its effect on histamine-induced itch and skin reactions.
Tripelennamine 1% topical creamEXPERIMENTALParticipants received a single topical application of tripelennamine 1% cream prior to histamine iontophoresis to evaluate its effect on histamine-induced itch and skin reactions.

Interventions

NameTypeDescription
TripelennamineDRUGTripelennamine 1% topical cream applied to the skin of one arm of an individual 15 minutes before the application of iontophoretically administered histamine 2% gel.
DiphenhydramineDRUGDiphenhydramine 1% topical cream applied to the skin of one arm of an individual 15 minutes before the application of iontophoretically administered histamine 2% gel.
Vehicle Control Cream BaseDRUGApproximately 0.2 g of vehicle cream base without antihistamine was applied topically to designated forearm test areas. The cream remained on the skin for 15 minutes before histamine iontophoresis was performed.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception. * No history of chronic itch or pain. * Must abstain from the use of any systemic or topical antihistamine, steroid, or pain relief medications from ...

Countries:United States
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Frequently asked questions about Tripelennamine

What is Tripelennamine used for?

Tripelennamine is an investigational small molecule being studied as a topical 1% cream for the relief of histamine-induced itching in healthy adults. It is currently in early Phase 1 clinical development and is not yet approved by the FDA.

What does Tripelennamine target?

Tripelennamine is an antihistamine that works by blocking the effects of histamine, a compound involved in allergic reactions and itching. In the clinical trial, it is being compared to diphenhydramine 1% cream for the relief of histamine-induced itching.

Who is developing Tripelennamine?

Tripelennamine is being developed by Atlantic International Corp. (ticker: ATLN). The company is conducting clinical trials to evaluate the safety and efficacy of the drug for the relief of histamine-induced itching.

What phase is Tripelennamine in?

Tripelennamine is in early Phase 1 clinical development. A proof-of-concept study in healthy adults has been completed, but the drug remains investigational and has not received FDA approval.

What clinical trials is Tripelennamine in?

Tripelennamine has one completed clinical trial, NCT07778472, which evaluated topical Tripelennamine 1% cream versus diphenhydramine 1% cream for the relief of histamine-induced itching in healthy adults. The study enrolled 37 participants in the United States.

Is Tripelennamine the same as diphenhydramine?

No, Tripelennamine is not the same as diphenhydramine. Both are antihistamines, but they are different drugs. In the clinical trial, Tripelennamine 1% cream was compared directly against diphenhydramine 1% cream to assess their relative effectiveness in relieving histamine-induced itching.