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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| ZORYVE | Arcutis Biotherapeutics | N-215985 RX | 2022-07-29 | 2 products, RLD, RS |
| ZORYVE | Arcutis Biotherapeutics | N-217242 RX | 2023-12-15 | 1 products, RLD, RS |
| DALIRESP | AstraZeneca | N-022522 RX | 2011-02-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daliresp | New Drug Application | 2020-03-12 |
| roflumilast | ANDA | 2025-07-24 |
| zoryve | New Drug Application | 2025-05-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic obstructive pulmonary disease | EFO_0000341 | D029424 | J44.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ROFLUMILAST, ZORYVE, ARCUTIS | |||
| 2025-07-29 | NP | ||
ROFLUMILAST, ROFLUMILAST, MSN | |||
| 2023-04-18 | PC | ||
ROFLUMILAST, ROFLUMILAST, HETERO LABS LTD III | |||
| 2023-04-17 | PC | ||
ROFLUMILAST, ROFLUMILAST, MYLAN | |||
| 2023-04-17 | PC | ||
ROFLUMILAST, ROFLUMILAST, STRIDES PHARMA | |||
| 2023-04-17 | PC | ||
Patent Expiration
HCPCS
No data
Clinical
Clinical Trials
128 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 disease | D029424 | EFO_0000341 | J44.9 | 2 | 7 | 17 | 10 | 10 | 44 |
| Obstructive lung diseases | D008173 | — | — | 1 | 4 | 13 | 7 | 5 | 29 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 4 | 12 | 6 | 3 | 24 |
| Eczema | D004485 | — | L30.9 | 1 | 4 | 5 | 1 | — | 11 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 3 | 1 | 2 | — | 6 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 1 | 2 | — | 3 |
| Disease progression | D018450 | — | — | — | — | — | 1 | 2 | 3 |
| Chronic disease | D002908 | — | — | — | 1 | — | 1 | — | 2 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | 1 | — | 1 |
| Bronchitis | D001991 | — | J40 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 9 | 7 | — | — | 16 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 4 | 6 | — | 2 | 12 |
| Dermatitis | D003872 | — | L30.9 | 1 | 5 | 6 | — | — | 12 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 4 | 5 | — | — | 10 |
| Bronchiectasis | D001987 | — | J47 | 1 | 4 | 1 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 1 | — | — | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 1 | — | — | 2 |
| Depression | D003863 | — | F33.9 | 1 | 1 | 1 | — | — | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 1 | — | — | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 2 | — | — | — | 2 |
| Fibrosis | D005355 | — | — | — | 2 | — | — | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 2 | — | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 1 | — | — | — | 1 |
| Amnesia | D000647 | EFO_1001454 | F44.0 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 4 | — | — | — | — | 4 |
| B-cell lymphoma | D016393 | — | — | 3 | — | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | — | — | — | — | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | 1 | 2 |
| Neuronal plasticity | D009473 | — | — | 1 | — | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | — | — | — | 1 |
| Memory disorders | D008569 | — | — | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Show 7 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | — | — | — | 1 | 1 |
| Pulmonary fibrosis | D011658 | — | J84.10 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Roflumilast |
| INN | roflumilast |
| 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 class | antiasthmatics/antiallergics (not acting primarily as antihistamines): type IV phosphodiesterase |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 162401-32-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL193240 |
| ChEBI ID | 47657 |
| PubChem CID | 449193 |
| DrugBank | DB01656 |
| UNII ID | 0P6C6ZOP5U (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
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Daliresp – AstraZeneca
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Estimated US medical usage
Roflumilast
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,216 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,485 adverse events reported
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