Moonlight Therapeutics' peanut allergy study on clinical hold

A phase 1 study of Moonlight Therapeutics' MOON101, a microneedle-based peanut allergen treatment, is listed as suspended, with the registry citing a "Clinical Hold" as the reason, per an update posted October 16, 2026. The record does not specify which agency issued the hold.

The trial, known as SURVEYOR (NCT07580898, sponsor ID U44-MNLT-01), is an open-label, single escalating dose study in 3 sequential groups of adults, adolescents, and children with peanut allergy designed to assess the safety of MOON101.¹ Moonlight Therapeutics is listed as the sole lead sponsor, with the National Institute of Allergy and Infectious Diseases (NIAID) named as a collaborator.

The study's main goals are to track the incidence and frequency of all treatment emergent adverse events from baseline through study exit, and to determine the highest tolerated dose for each participant, defined as the highest MOON101 dose level that did not cause a dose-limiting symptom.¹

MOON101 is described as a microneedle stamp, a square stainless steel array, coated with peanut extract as the active drug¹, administered across five escalating doses: 1 μg, 10 μg, 25 μg, 50 μg, and 100 μg of peanut extract, with matching placebo at each level, as stated in the design. A total of approximately 40 participants was planned, split into Group 1 adults (n=10), Group 2 adolescents (n=10), and Group 3 children (n=20).¹

An independent NIAID Data and Safety Monitoring Board was set to meet periodically to review safety data and make recommendations on advancing to Group 2 and Group 3.¹ The study actually started June 29, 2026, with an estimated primary completion date of December 31, 2027, according to the registry.