Overview
Roflumilast is a highly selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is a major cyclic-3',5′-adenosinemonophosphate (cyclic AMP, cAMP)-metabolizing enzyme expressed on nearly all immune and pro-inflammatory cells, in addition to structural cells like those of the smooth muscle or epithelium. The resultant increase in intracellular cAMP induced by roflumilast's inhibition of PDE4 is thought to mediate its disease-modifying effects, although its precise mechanism of action has yet to be elucidated. The oral formulation of roflumilast is indicated to manage the chronic obstructive pulmonary disease. It was first approved by the EMA in July 2010, and by the FDA in January 2018. Roflumilast topical cream is indicated to treat plaque psoriasis. It was first approved by FDA in July 2022 and by Health Canada in April 2023.
Indication
Oral roflumilast is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Topical roflumilast is indicated to treat plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Associated Conditions
- Exacerbation of COPD
- Psoriasis Vulgaris (Plaque Psoriasis)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/18 | Phase 1 | Recruiting | |||
2025/03/06 | Phase 3 | Recruiting | |||
2024/11/07 | Phase 2 | Completed | |||
2024/10/18 | Phase 3 | Recruiting | |||
2024/10/16 | Early Phase 1 | Recruiting | |||
2024/10/08 | Phase 3 | Recruiting | |||
2024/06/13 | Phase 1 | Active, not recruiting | |||
2024/06/03 | Phase 4 | Recruiting | |||
2023/06/01 | Phase 1 | Not yet recruiting | |||
2023/03/10 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | 0310-0095 | ORAL | 500 ug in 1 1 | 3/12/2020 | |
| Golden State Medical Supply, Inc. | 51407-975 | ORAL | 500 ug in 1 1 | 3/21/2025 | |
| Zydus Lifesciences Limited | 70771-1673 | ORAL | 250 ug in 1 1 | 9/27/2023 | |
| Arcutis Biotherapeutics, Inc. | 80610-130 | TOPICAL | 3 mg in 1 g | 1/19/2024 | |
| American Health Packaging | 60687-786 | ORAL | 500 ug in 1 1 | 10/30/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-201 | ORAL | 250 ug in 1 1 | 10/28/2019 | |
| Camber Pharmaceuticals, Inc. | 31722-623 | ORAL | 500 ug in 1 1 | 4/28/2023 | |
| AstraZeneca Pharmaceuticals LP | 0310-0088 | ORAL | 250 ug in 1 1 | 3/12/2020 | |
| Novadoz Pharmaceuticals LLC | 72205-200 | ORAL | 500 ug in 1 1 | 10/28/2019 | |
| Camber Pharmaceuticals, Inc. | 31722-676 | ORAL | 250 ug in 1 1 | 4/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/5/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ROFMILAS TABLETS 500MCG | N/A | N/A | N/A | 1/8/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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