mufemilast (Hemay005) / Tianjin Hemay Pharma - LARVOL DELTA

Evaluation the Safety of hemay005 Tablets (clinicaltrials.gov) - P1 | N=468 | Completed | Sponsor: Anhui Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Sep 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • Renal Disease

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2025

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

ORAL MUFEMILAST (A NOVEL SELECTIVE PDE4INHIBITOR) DEMONSTRATES EFFICACY AND SAFETY IN A PHASE II MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION TRIAL IN CHINESE PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (UEGW 2025) - P2 | "Mufemilast efficacy and safety were consistent across subgroups regardless of previous biologic use, suggesting Mufemilast is a viable potential future treatment option in patients with moderate to severe UC that breaks through the current 20% ceiling for clinical remission. A phase 3 study will be conducted to confirm these results."

Clinical • Late-breaking abstract • P2 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • IL12A

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease (clinicaltrials.gov) - P3 | N=162 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Mar 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2024 ➔ May 2026

Trial completion date • Trial primary completion date • Rare Diseases

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Evaluation the Safety of hemay005 Tablets (clinicaltrials.gov) - P1 | N=468 | Recruiting | Sponsor: Anhui Hemay Pharmaceutical Co., Ltd

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • Renal Disease

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Bioequivalence Test of Hemay005 Tablets (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial primary completion date • Dermatology • Immunology • Psoriasis

Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology. (PubMed, Pharmaceutics) - "Apremilast was the first PDE4 inhibitor approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for psoriasis, psoriatic arthritis, and oral ulcers of Behcet's disease. New oral PDE4 inhibitors are being developed, such as orismilast (LEO-32731), mufemilast (Hemay005), difamilast (OPA-15406) or lotamilast (E6005/RVT-501), among others. This narrative review provides a comprehensive synthesis of the pharmacology, clinical efficacy, safety profile, and practical considerations regarding the oral and topical use of PDE4 inhibitors in dermatology."

Journal • Review • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dental Disorders • Dermatitis • Dermatology • Dermatopathology • Discoid Lupus Erythematosus • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Lichen Planus • Lupus • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Sarcoidosis • Seborrheic Dermatitis • Seronegative Spondyloarthropathies • Stomatitis

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Bioequivalence Test of Hemay005 Tablets (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Renal Disease

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis • Renal Disease

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Study of Hemay005 in Adult With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=79 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed | Trial primary completion date: Jul 2023 ➔ Jan 2024

Trial completion • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2023

Trial completion • Trial completion date

In Vivo Mass Balance Study of [14C]Hemay005 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed

Trial completion

A Phase Ⅲ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=306 | Completed | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis (clinicaltrials.gov) - P2 | N=90 | Completed | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2023 | Trial primary completion date: Nov 2023 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TNFA

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease (clinicaltrials.gov) - P3 | N=162 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P3 trial • Rare Diseases