Mufemilast

Summary

Mufemilast (CHEMBL5095240) is a phase-3 clinical-stage small molecule; indicated across 5 conditions including psoriasis and behcet disease.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 5 conditions
• Clinical trials: 18
• Chemistry: 466.5 Da · C20H22N2O7S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095240
Name	Mufemilast
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	137355584
Molecular formula	C20H22N2O7S2
Molecular weight	466.5
InChIKey	PRSNGWLHNWGOKD-CQSZACIVSA-N

SMILES: CCOC1=C(C=CC(=C1)[C@@H](CS(=O)(=O)C)N2C(=O)C3=CSC(=C3C2=O)NC(=O)C)OC

IUPAC name: N-[5-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4,6-dioxothieno[3,4-c]pyrrol-3-yl]acetamide

Also known as: HEMAY-005, HEMAY005, Mufemilast, MUFEMILAST

Patent coverage: 33 distinct patent families (103 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Phosphodiesterase 4, 3’,5’-cyclic-AMP phosphodiesterase 4D.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
PDE4A	6.94	IC50	114	nM	CHEMBL_ACT_29156685
PDE4D	6.94	IC50	114	nM	CHEMBL_ACT_29243150

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

5 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
psoriasis	3	MONDO:0005083	EFO:0000676
Behcet disease	2	MONDO:0007191	EFO:0003780
ankylosing spondylitis	2	MONDO:0005306	EFO:0003898
atopic eczema	2	MONDO:0004980	EFO:0000274
ulcerative colitis	2	MONDO:0005101	EFO:0000729

Clinical trials

Total trials: 18.

Phase distribution

Phase	Trials
PHASE1	10
PHASE2	6
PHASE3	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06145893	PHASE3	RECRUITING	A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet’s Disease
NCT04839328	PHASE3	COMPLETED	A Phase Ⅲ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
NCT05486104	PHASE2	ACTIVE_NOT_RECRUITING	Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
NCT07314242	PHASE2	NOT_YET_RECRUITING	A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD
NCT04102241	PHASE2	COMPLETED	Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
NCT04609397	PHASE2	TERMINATED	A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
NCT05407246	PHASE2	COMPLETED	Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis
NCT05769946	PHASE2	COMPLETED	A Study of Hemay005 in Adult With Atopic Dermatitis
NCT06376474	PHASE1	RECRUITING	To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
NCT03007810	PHASE1	COMPLETED	Safety and Pharmacokinetics of Hemay005 In Healthy Male Subjects
NCT03570346	PHASE1	UNKNOWN	Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
NCT03577626	PHASE1	UNKNOWN	A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers
NCT04837235	PHASE1	COMPLETED	Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
NCT05941247	PHASE1	COMPLETED	A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers
NCT06380153	PHASE1	COMPLETED	To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment
NCT06610890	PHASE1	COMPLETED	Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
NCT06610903	PHASE1	COMPLETED	Bioequivalence Test of Hemay005 Tablets
NCT06908642	PHASE1	COMPLETED	Evaluation the Safety of hemay005 Tablets

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).