Daliresp, Daxas(roflumilast)
Daliresp, Daxas, 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 cAMP-specific 3',5'-cyclic phosphodiesterase 4B. In addition, it is known to target cAMP-specific 3',5'-cyclic phosphodiesterase 4D.
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Commercial
Trade Name
FDA
EMA
Daliresp, Zoryve (generic drugs available since 2018-07-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daliresp | New Drug Application | 2020-03-12 |
| roflumilast | New Drug Application | 2022-08-05 |
| roflumilast | ANDA | 2023-05-18 |
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
107 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 | 18 | 9 | 5 | 39 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 2 | 1 | 2 | — | 5 |
| Chronic bronchitis | D029481 | J42 | — | — | 1 | 1 | — | 2 | |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | — | 1 | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | 1 | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | 1 | — | 1 |
| Respiration disorders | D012120 | J00-J99 | — | — | — | 1 | — | 1 | |
| Disease progression | D018450 | — | — | — | 1 | — | 1 | ||
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | 1 | — | 1 |
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 | 4 | — | — | 13 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 4 | 6 | — | — | 10 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | 1 | 4 | 1 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 1 | — | — | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 1 | — | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | 1 | |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 2 | — | — | — | 3 |
| Dementia | D003704 | F03 | — | 2 | — | — | — | 2 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | — | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Amnesia | D000647 | EFO_1001454 | F44.0 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | — | 1 | |
| Nervous system diseases | D009422 | G00-G99 | 1 | 1 | — | — | — | 1 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | — | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | 1 | 2 |
| Neuronal plasticity | D009473 | 1 | — | — | — | — | 1 | ||
| B-cell lymphoma | D016393 | 1 | — | — | — | — | 1 | ||
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | 1XOQ |
| CAS-ID | 162401-32-3 |
| RxCUI | 1091836 |
| 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
cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Mouse ortholog
Pde4b (18578)
cAMP-specific 3',5'-cyclic phosphodiesterase 4B (Q8VBU5)
Alternate
PDE4D
PDE4D
Organism
Homo sapiens
Gene name
PDE4D
Gene synonyms
DPDE3
NCBI Gene ID
Protein name
cAMP-specific 3',5'-cyclic phosphodiesterase 4D
Protein synonyms
cAMP-specific phosphodiesterase PDE4D6, DPDE3, PDE43, phosphodiesterase 4D, cAMP-specific (phosphodiesterase E3 dunce homolog, Drosophila), testicular tissue protein Li 136
Uniprot ID
Mouse ortholog
Pde4d (238871)
cAMP-specific 3',5'-cyclic phosphodiesterase 4D (Q8CG05)
Variants
Clinical Variant
No data
Financial
Daliresp - AstraZeneca
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,321 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,941 adverse events reported
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