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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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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
Start date
Primary completion date
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
3 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
roflumilastANDA2026-02-09
zoryveNew Drug Application2026-01-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic obstructive pulmonary diseaseEFO_0000341D029424J44.9
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
134 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40264——11
EczemaD004485—L30.9124——7
DermatitisD003872—L30.9123——6
Atopic dermatitisD003876EFO_0000274L20122——5
Seborrheic dermatitisD012628—L21—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hidradenitis suppurativaD017497—L73.2—1———1
VitiligoD014820EFO_0004208L80—1———1
Indications Phases 1
No data
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
5142
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
Q5TEK6
Mouse ortholog
Pde4b (18578)
3',5'-cyclic-AMP phosphodiesterase 4B (Q9QXI7)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Daliresp – AstraZeneca
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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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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,607 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,492 adverse events reported
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