mufemilast (Hemay005) / Tianjin Hemay Pharma - LARVOL DELTA

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

A Double-blind, Placebo-parallel Controlled Phase III Clinical Study of the Efficacy and Safety of Hemay005 Tablets in Patients with Moderate to Severe Chronic Plaque Psoriasis in China (ACR Convergence 2023) - "Improvements in the side effect /efficacy ratio vs Apremilast are anticipated to improve the efficacy of Apremilast, which was side effect limited at doses >30mg. Hemay005 has the potential to be the best-in-class oral PDE4 in the management of psoriasis. The results from this study showed that Hemay005 significantly reduced the severity of moderate to severe plaque psoriasis over 16 weeks. Most AEs were mild."

Clinical • P3 data • Dermatology • Dyslipidemia • Gastrointestinal Disorder • Hypertriglyceridemia • Immunology • Infectious Disease • Inflammation • Pain • Psoriasis • IFNG • IL12A • IL2 • IL23A • TNFA

A Phase II Clinical Study to Investigate the Efficacy and Safety of Hemay005 Tablets in Patients with Active Behçet`sDisease (ACR Convergence 2023) - "Improvements in the side effect /efficacy ratio vs Apremilast are anticipated to improve on the efficacy of Apremilast, which was side effect limited at doses >30mg. Hemay005 60 mg BID and 45 mg BID for 12 weeks effectively reduced the AUC for the number of oral ulcers from baseline to Week 12 in BD patients. The study drug was safe and well-tolerated. A phase Ⅲ clinical trial in patients with Bechet's disease is underway."

Clinical • P2 data • Cardiovascular • Gastrointestinal Disorder • Inflammation • Ophthalmology • Rare Diseases • IFNG • IL12A • IL2 • IL23A • TNFA

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

Enrollment closed

A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial