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Drug ReportsRoflumilast
Daliresp, Daxas(roflumilast)
Daliresp, Daxas, Roflumilast, Zoryve (roflumilast) is a small molecule pharmaceutical. Roflumilast was first approved as Daxas on 2010-07-05. It is used to treat chronic obstructive pulmonary disease in the USA. It has been approved in Europe to treat chronic obstructive pulmonary disease. The pharmaceutical is active against 3',5'-cyclic-AMP phosphodiesterase 4B.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Daliresp, Roflumilast, Zoryve (discontinued: Roflumilast)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Roflumilast
Tradename
Company
Number
Date
Products
ZORYVEArcutis BiotherapeuticsN-215985 RX2022-07-29
2 products, RLD, RS
ZORYVEArcutis BiotherapeuticsN-217242 RX2023-12-15
1 products, RLD, RS
DALIRESPAstraZenecaN-022522 RX2011-02-28
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dalirespNew Drug Application2020-03-12
roflumilastANDA2025-03-21
zoryveNew Drug Application2025-02-21
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
ROFLUMILAST, ZORYVE, ARCUTIS
2025-07-29NP
ROFLUMILAST, ROFLUMILAST, MSN
2023-04-18PC
ROFLUMILAST, ROFLUMILAST, HETERO LABS LTD III
2023-04-17PC
ROFLUMILAST, ROFLUMILAST, MYLAN
2023-04-17PC
ROFLUMILAST, ROFLUMILAST, STRIDES PHARMA
2023-04-17PC
Patent Expiration
Patent
Expires
Flag
FDA Information
Roflumilast, Zoryve, Arcutis
111298182037-08-25DPU-3408
98840502037-06-07DP
99077882037-06-07DPU-3408
109401422037-06-07DP
Roflumilast, Daliresp, Astrazeneca
85362062024-03-08U-1115
86040642024-03-08U-1115
86181422024-03-08DP
84311542023-02-19DP
94685982023-02-19DP
ATC Codes
R: Respiratory system drugs
R03: Drugs for obstructive airway diseases
R03D: Other systemic drugs for obstructive airway diseases in atc
R03DX: Other systemic drugs for obstructive airway diseases in atc
R03DX07: Roflumilast
HCPCS
No data
Clinical
Clinical Trials
123 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.912142624
Obstructive lung diseasesD00817312132421
Lung diseasesD008171EFO_0003818J98.42122217
Respiratory tract diseasesD01214011
Respiration disordersD012120J00-J9911
Disease progressionD01845011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J45368
Respiratory signs and symptomsD01281811
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Memory disordersD00856911
Alzheimer diseaseD000544EFO_0000249F0311
Healthy volunteers/patients11
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRoflumilast
INNroflumilast
Description
Roflumilast is a benzamide obtained by formal condensation of the carboxy group of 3-(cyclopropylmethoxy)-4-(difluoromethoxy)benzoic acid with the amino group of 3,5-dichloropyridin-4-amine. Used for treatment of bronchial asthma and chronic obstructive pulmonary disease. It has a role as a phosphodiesterase IV inhibitor and an anti-asthmatic drug. It is a member of benzamides, a chloropyridine, an aromatic ether, an organofluorine compound and a member of cyclopropanes.
Classification
Small molecule
Drug classantiasthmatics/antiallergics (not acting primarily as antihistamines): type IV phosphodiesterase
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Identifiers
PDB
CAS-ID162401-32-3
RxCUI
ChEMBL IDCHEMBL193240
ChEBI ID47657
PubChem CID449193
DrugBankDB01656
UNII ID0P6C6ZOP5U (ChemIDplus, GSRS)
Target
Agency Approved
PDE4B
PDE4B
Organism
Homo sapiens
Gene name
PDE4B
Gene synonyms
DPDE4
NCBI Gene ID
Protein name
3',5'-cyclic-AMP phosphodiesterase 4B; cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
cAMP-specific phosphodiesterase 4B, DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Mouse ortholog
Pde4b (18578)
3',5'-cyclic-AMP phosphodiesterase 4B (Q9QXI7)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Daliresp AstraZeneca
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Tabular view
Estimated US medical usage
Roflumilast
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,976 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,253 adverse events reported
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