IN-115314 / Korea Kolmar - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients (clinicaltrials.gov) - P1 | N=81 | Completed | Sponsor: HK inno.N Corporation | Not yet recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients (clinicaltrials.gov) - P2 | N=162 | Recruiting | Sponsor: HK inno.N Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Novel Topical JAK1 Inhibitor for Atopic Dermatitis: Safety and Early Efficacy of IN-115314 (EADV 2025) - "In the patient cohort, individuals with 3–30% body surface area (BSA) involvement and mild to moderate AD (EASI score < 23) received either 1% or 3% IN-115314 ointment, or pimecrolimus cream, applied twice daily for 28 days, with twelve participants (8 active:4 comparator) in each group. IN-115314 showed favorable safety, low systemic exposure, and early signs of clinical efficacy when applied topically to both healthy individuals and patients with AD. These findings support its further development as a topical selective JAK1 inhibitor for the treatment of atopic dermatitis."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13 • IL22 • IL4

A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: HK inno.N Corporation

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

JAK-STAT inhibitory effect of IN-115314, a novel small molecule inhibitor, and pharmacokinetic/pharmacodynamic study in canine. (PubMed, Br J Pharmacol) - "In summary, this study confirmed IN-115314 JAK-STAT inhibitory effect, along with data on its pharmacokinetics, pharmacodynamics, safety, efficacy and optimal dosage. We anticipate that IN-115314 will be developed as a new therapeutic agent for various diseases involving the JAK-STAT pathway."

Journal • PK/PD data • CD4 • IL6 • JAK1 • JAK2

HK inno.N, this time, challenges a new drug called ’JAK inhibitor’ for atopic dermatitis [Google translation] (Medipharms Today) - "On the 12th, the Ministry of Food and Drug Safety approved the phase 2 clinical trial of HK inno.N's 'IN-115314'. This trial was a randomized, double-blind, placebo-controlled, parallel, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of IN-115314 ointment in adult patients with mild to moderate atopic dermatitis."

New P2 trial • Atopic Dermatitis

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: HK inno.N Corporation

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

"Dec 2, 1986 First participant enrolled in A002 #HIV #ResearchersRock @ACTGNetwork @WCM_ID @joseph_eron @6dm4 @MorenikeGO @MARTHOLANAH @Flatmi @EmoryCFAR @rstrange_dc @AwesomeJonesLab @REACHforthecure @TheNixonLab @HOPEforHIVCure https://t.co/pv7Oxt4KlI" (,@YvesGebhardt)

Human Immunodeficiency Virus • Infectious Disease

A Study to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: HK inno.N Corporation

Clinical • New P1 trial

[VIRTUAL] PRECLINICAL CHARACTERIZATION OF CJ-15314, A HIGHLY SELECTIVE JAK1 INHIBITOR, FOR THE TREATMENT OF AUTOIMMUNE DISEASES (EULAR 2020) - "Tofacitinib, oral Pan-JAK inhibitor, demonstrated efficacy in RA patients, but its widespread use is limited by safety issues...Accordingly, in human whole blood assays, CJ-15314 is 11 fold more potent against IL-6 induced pSTAT1 inhibition through JAK1 (IC50 value: 70 nM) than GM-CSF-induced pSTAT5 inhibition (JAK2) whereas baricitinib and filgotinib exhibited only 2 fold and 7 fold respectively... CJ-15314 is a highly selective JAK1 inhibitor, demonstrates robust efficacy in RA animal model and is good candidate for further development for inflammatory diseases. * CJ-15314 is currently conducting a phase I trial in south Korea."

Preclinical • Hematological Disorders • Immunology • Rheumatology • Thrombocytopenia • CXCL8 • IL6 • JAK2 • JAK3

Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects (clinicaltrials.gov) - P1; N=55; Recruiting; Sponsor: CJ HealthCare Corporation

Clinical • New P1 trial