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
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KOSDAQ Filing Information
- 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