Organon pauses dosing in Phase 3 tapinarof trial for infants with atopic dermatitis
The company suspended the study after a pharmacokinetic finding, though it reports no new safety signal, as enrollment stood at 187 participants.
Organon and Co has suspended dosing in a Phase 3 trial testing Tapinarof cream, 1% in infants and toddlers with atopic dermatitis, according to the study's ClinicalTrials.gov record. The trial, registered as NCT07265479 and known by the acronym Adoring, listed an overall status of suspended, with the sponsor citing a pharmacokinetic finding as the reason for the pause. The status update describes dosing as paused as a precaution due to a PK finding in the related study OG505-3104.1 Organon said it is further investigating and assessing the data.1
The study began on 2025-12-29, with a primary completion estimated for 2027-08 and study completion also estimated for 2027-08.1 It was first posted on December 4, 2025, and last updated on October 5, 2026, according to the same record.
The trial enrolled 187 participants in a randomized, quadruple-masked, parallel design comparing tapinarof cream applied once daily against a vehicle cream placebo.1 Eligible participants were infants and toddlers born at term, ages 3 months to under 24 months, with atopic dermatitis.1
The main efficacy measure tracks the percentage of participants achieving a validated Investigator Global Assessment score of clear or almost clear with at least a 2-grade improvement from baseline to week 8.1 The study is being run at 46 sites across the United States and Canada.1 Organon and Co is listed as the lead sponsor.
Fact check notes
- Imprecise
The status update describes dosing as paused as a precaution due to a PK finding in the related study OG505-3104.
OG505-3104 (entry) / OG0505-3104 (source) appears to be this very study's own sponsor ID, not a separate 'related study' as the entry implies; also a minor digit/number discrepancy (OG505 vs OG0505). - Checker's noteThe entry describes the PK finding as occurring 'in the related study OG505-3104,' implying a separate trial, but OG0505-3104 is this same study's sponsor ID, not a distinct related study.
- Checker's noteMinor identifier mismatch: entry writes 'OG505-3104' while the source lists 'OG0505-3104.'
- Sentence removed
The sponsor stated that no safety signal or change to the established safety or benefit-risk profile has been identified.
copied source wording
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.