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.
Download report
Favorite
Events Timeline
Commercial
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
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2024-09-04 |
| zoryve | New Drug Application | 2024-07-11 |
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
122 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | HP_0006536 | — | 1 | 4 | 14 | 8 | 5 | 31 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 4 | 13 | 7 | 3 | 26 |
| Eczema | D004485 | HP_0000964 | L30.9 | 1 | 3 | 5 | 1 | — | 10 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 3 | 1 | 2 | — | 6 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 1 | 2 | — | 3 |
| Bronchitis | D001991 | — | J40 | — | — | 1 | 2 | — | 3 |
| Disease progression | D018450 | — | — | — | — | — | 1 | 2 | 3 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 2 | — | 2 |
| Chronic disease | D002908 | — | — | — | 1 | — | 1 | — | 2 |
Show 9 more
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 | HP_0011123 | L30.9 | 1 | 4 | 6 | — | — | 11 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 3 | 5 | — | — | 9 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | 1 | 4 | 1 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 1 | — | — | 3 |
| Seborrheic dermatitis | D012628 | HP_0001051 | L21 | — | 1 | 1 | — | — | 2 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | 1 | 1 | 1 | — | — | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 1 | — | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 1 | — | — | — | 2 |
| 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 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 2 | — | — | — | 2 |
| Depression | D003863 | — | F33.9 | 1 | 1 | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 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 | 3 | — | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | 2 | — | — | — | — | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | 1 | 2 |
| Neuronal plasticity | D009473 | — | — | 1 | — | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 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 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | — | — | — | 1 | 1 |
| Pulmonary fibrosis | D011658 | — | — | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
Revenue by drug
$
€
£
₣
Daliresp – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Roflumilast
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,830 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
4,075 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use