Drug ID:Drug75
Drug Name:Roflumilast
CID:449193
DrugBank ID:DB01656
Modality:Small Molecule
Groups:approved
US Approved:YES
Other Approved:YES
Identifier: NCT04209556
Molecular Formula:C17H14Cl2F2N2O3
Molecular Weight:403.2 g/mol
Isomeric SMILES:C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
Synonyms:Roflumilast; 162401-32-3; DAXAS; 3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLOROPYRIDIN-4-YL)-4-(DIFLUOROMETHOXY)BENZAMIDE; Daliresp; BY217; BYK20869; Benzamide, 3-(cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-; BY-217; ZORYVE
Phase 0: 3
Phase 1: 17
Phase 2: 44
Phase 3: 39
Phase 4: 18
Description:Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor. Due to its selective inhibition of the PDE4 isoenzyme in lung cells, roflumilast is indicated for the management of chronic obstrtuctive pulmonary disease (COPD) exacerbations. Treatment with Roflumilast is associated with an increase in psychiatric adverse reactions, including suicide and suicidal attempts.

Molecular Structure

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
dt636 449193 Roflumilast 1080 CFTR Homo sapiens (human) None
dt637 449193 Roflumilast 5143 PDE4C Homo sapiens (human) Inhibitor
dt638 449193 Roflumilast 5141 PDE4A Homo sapiens (human) None
dt639 449193 Roflumilast 5141 PDE4A Homo sapiens (human) 20689641 Inhibitor
dt640 449193 Roflumilast 5142 PDE4B Homo sapiens (human) 20689641 Inhibitor
dt641 449193 Roflumilast 5143 PDE4C Homo sapiens (human) 20689641 Inhibitor
dt642 449193 Roflumilast 5144 PDE4D Homo sapiens (human) 20689641 Inhibitor
dt643 449193 Roflumilast 1576 CYP3A4 Homo sapiens (human) Substrate
dt644 449193 Roflumilast 1544 CYP1A2 Homo sapiens (human) 20689641 Substrate

  • No data available

Phase Distribution
Phase Description
  • Phase 0: Exploratory trials to assess drug behavior in humans
  • Phase 1: Safety trials to determine safe dosage range
  • Phase 2: Efficacy trials to evaluate therapeutic effects
  • Phase 3: Large-scale trials to confirm efficacy and safety
  • Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial IDTitlePhaseStatusSponsorIndicationsInterventions
NCT05684484 Role of Roflumilast in Ulcerative Colitis PHASE4 COMPLETED Tanta University Ulcerative Colitis DRUG: Roflumilast 500 MCG Oral Tablet [DALIRESP]|… Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
S07 Blockade of cytokine Cytokine signalling apremilast; roflumilast; filgotinib; tofacitinib; ABT494; ABT-874; ustekinumab; isankizumab; LY-2525623; AMG139; MEDI2079; guselkumab Various T-cell subsets, their differentiation pathways and … Details

Roflumilast, type 4 phosphodiesterase inhibitor, attenuates inflammation in rat…

PMID: 29331766
Year: 2018
Relationship Type: Treatment Score: 6.3

BACKGROUND: Roflumilast (Rof), a phosphodiesterase 4 (PDE4) inhibitor, has been shown to be an effective agent in inflammatory diseases and marketed …

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