IN-115314 Atopic Dermatitis Treatment Gets FDA Phase 1b IND Approval

US FDA approved Phase 1b IND for IN-115314 ointment for mild to moderate atopic dermatitis (decision date: 2026-05-01)
Phase 1b: randomized, double-blind, placebo-controlled, dose-escalation, multi-center (5 US sites), target 36 patients
Primary endpoint: safety and tolerability; secondary: pharmacokinetics; exploratory efficacy
Trial duration: approx. 12 months from first patient enrollment to last patient visit (estimated completion 2027-05-01)
FDA approval deemed after 30 days of no communication following submission (per CFR)
Investment caution: clinical success rate statistically ~10%; possibility of plan changes or abandonment due to unfavorable results

Filing: Key Management Matters Related to Investment Decision (Decision on Clinical Trial Plan Approval Application, etc.) (Approval of Investigational New Drug (IND) for Phase 1b Clinical Trial of IN-115314, a Candidate for Mild to Moderate Atopic Dermatitis Treatment, by the U.S. Food and Drug Administration (FDA))
Company: HK inno.N (195940)
Submission: HK inno.N Corporation
Receipt: 05-13-2026
Under KRX KOSDAQ Market Division