Clinical-stage · Phase 2 in progress

Targeting the root of mast-cell–driven disease.

Calixis is developing a wild-type KIT inhibitor designed to deplete mast cells — the immune cells that drive chronic spontaneous urticaria and a range of allergic and inflammatory diseases.

Phase 2
study currently ongoing in chronic spontaneous urticaria
Oral
once-daily small-molecule design
KIT
Wild-type selective mechanism
molecule
Many mast-cell–driven diseases
Hives · itch Mast cell
In chronic spontaneous urticaria, skin mast cells release histamine and other mediators, producing recurring hives, swelling, and itch.
The unmet need

Millions live with disease driven by a single cell type.

Chronic spontaneous urticaria (CSU) causes unpredictable hives and swelling that can persist for years. Many patients continue to have symptoms despite antihistamines and existing therapies.

Across CSU and many other allergic and inflammatory conditions, the mast cell sits at the center of the pathology. We believe that reducing these cells at the source — rather than blocking one mediator at a time — could offer more complete and durable control.

See how our approach works
Our approach

Depleting mast cells by targeting wild-type KIT

Signaling through the KIT receptor is essential for mast cells to develop and survive. Our oral small molecules are designed to shut down that signal.

Precise target

We inhibit wild-type KIT — the form present in normal mast cells.

Depletion, not just blocking

By removing KIT survival signaling, we aim to reduce the mast-cell population itself, addressing the source of mediator release rather than one downstream signal.

Oral, once-daily design

A convenient oral small molecule is intended to make treatment practical for chronic, long-term use across a broad patient population.

Chronicurticaria Allergicdisease Mast celldisorders Asthma Atopicskin GI &other More Mast cell
A pipeline, not a single drug

One mechanism. Many diseases.

Chronic spontaneous urticaria is our first indication — chosen because its biology is clearly mast-cell driven. Because mast cells contribute to the pathology of many allergic and inflammatory conditions, we intend to advance our KIT-inhibition approach into additional diseases where depleting these cells could change outcomes.

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Latest news

Company updates

All news
Clinical

Calixis announces commencement of a Phase 2 trial of oral KIT inhibitor THB335 in chronic spontaneous urticaria

Randomized, double-blind, placebo-controlled study of once-daily THB335 in adults who remain symptomatic despite antihistamines.

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Corporate

Calixis announces $45 million Series A financing from blue-chip life-science investors

Financing from Atlas Venture, OrbiMed, and Aditum Bio will advance the company's pipeline of oral mast-cell–targeted therapies.

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Interested in our science or partnering?

We welcome inquiries from investigators, potential partners, investors, and members of the patient community.

Calixis's investigational compounds have not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Their safety and efficacy have not been established. This website is intended for general informational purposes only and is not medical advice.