Last update 16 Oct 2025

Mufemilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
HEMAY 005, HEMAY-005, HEMAY005
Target
PDE4 x PDE4B
Action
inhibitors
Mechanism
PDE4 inhibitors(Phosphodieterase 4 inhibitors), PDE4B inhibitors(Phosphodiesterase 4B inhibitors)
Therapeutic Areas
Immune System DiseasesCardiovascular DiseasesCongenital Disorders+ [7]
Active Indication
Plaque psoriasisBehcet SyndromeModerate Atopic Dermatitis+ [5]
Inactive Indication-
Originator Organization
Tianjin Hemei Biological Technology Co.,Ltd.
Active Organization
Ganzhou Hemei Pharmaceutical Co LtdTianjin Hemei Biological Technology Co.,Ltd.
Inactive Organization
Hainan Hailing Chemipharma Corp. Ltd.Hainan Hailing Chemipharma Corp. Ltd.Tianjin Hemay Pharmaceutical Technology Co., Ltd.Tianjin Hemay Pharmaceutical Technology Co., Ltd.
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (30 Sep 2025),
Plaque psoriasis
RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC20H22N2O7S2
InChIKeyPRSNGWLHNWGOKD-CQSZACIVSA-N
CAS Registry1255909-03-5

Related

18
Clinical Trials associated with Mufemilast
NCT06908642
/ RecruitingPhase 1
Evaluation of the Safety of Hemay005 Tablets in Multiple Doses and Different Administration Methods in Multiple Administrations for Chinese Adult Healthy Subjects in a Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial
NCT06610890
/ RecruitingPhase 1
Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
NCT06610903
/ CompletedPhase 1
Study Protocol for a Single-center, Randomized, Open-label, Two-formulation, Single-dose, Two-cycle, Double-crossover Fasting Bioequivalence Trial of Hemay005 Tablets in Healthy Subjects
100 Clinical Results associated with Mufemilast
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100 Translational Medicine associated with Mufemilast
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100 Patents (Medical) associated with Mufemilast
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1
Literatures (Medical) associated with Mufemilast
01 Jun 2018BioanalysisQ4 · MEDICINE
Determination of a PDE4 Inhibitor Hemay005 in Human Plasma and Urine by UPLC–MS/MS and its Application to a PK Study
Q4 · MEDICINE
100 Deals associated with Mufemilast
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Plaque psoriasis
China
Ganzhou Hemei Pharmaceutical Co Ltd
30 Sep 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Behcet SyndromePhase 3
China
Ganzhou Hemei Pharmaceutical Co Ltd
16 Oct 2023
Moderate Atopic DermatitisPhase 2
China
Ganzhou Hemei Pharmaceutical Co Ltd
24 Nov 2022
Severe Atopic DermatitisPhase 2
China
Ganzhou Hemei Pharmaceutical Co Ltd
24 Nov 2022
Colitis, UlcerativePhase 2
China
Ganzhou Hemei Pharmaceutical Co Ltd
08 Nov 2022
Ankylosing SpondylitisPhase 2
China
Tianjin Hemei Biological Technology Co.,Ltd.
05 Aug 2022
Pulmonary Disease, Chronic ObstructivePhase 1
China
Ganzhou Hemei Pharmaceutical Co Ltd
25 Dec 2024
PsoriasisPhase 1-
Tianjin Hemay Pharmaceutical Technology Co., Ltd.Tianjin Hemay Pharmaceutical Technology Co., Ltd.
10 Oct 2018
Crohn DiseaseIND Approval
China
Ganzhou Hemei Pharmaceutical Co Ltd
21 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ACR2023
Phase 2
-
90
udiwyyhtku(rssajblxdb) = hroazrhzmh ahofjagbxq (zhmblbnnny )
Positive
14 Nov 2023
NCT04839328 (ACR2023)
Phase 3
Plaque psoriasis
-
xkmgcofigf(gmvljddoqd) = xosipkvoed qwbejqplaz (dcpptexgyv )
-
13 Nov 2023
Placebo
xkmgcofigf(gmvljddoqd) = uewnduqrkk qwbejqplaz (dcpptexgyv )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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