Overview
Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline . Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug . The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.
Background
Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline . Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug . The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.
Indication
Indicated for the treatment of chronic obstructive pulmonary disease (COPD), bronchial asthma and pulmonary disease with spastic bronchial component.
Associated Conditions
- Bronchial Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Lung Disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/04 | Phase 4 | Completed | |||
2020/01/23 | Phase 4 | UNKNOWN | |||
2019/03/19 | Phase 3 | UNKNOWN | Universidad Autonoma de Nuevo Leon |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| Doxofylline and Glucose Injection | 国药准字H20030567 | 化学药品 | 注射剂 | 6/22/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20031017 | 化学药品 | 注射剂 | 8/31/2021 | |
| Doxofylline and Glucose Injection | 国药准字H20030619 | 化学药品 | 注射剂 | 5/20/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20050132 | 化学药品 | 注射剂 | 11/15/2022 | |
| Doxofylline and Glucose Injection | 国药准字H20030371 | 化学药品 | 注射剂 | 7/23/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20030696 | 化学药品 | 注射剂 | 6/24/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20030618 | 化学药品 | 注射剂 | 11/2/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20030829 | 化学药品 | 注射剂 | 11/30/2020 | |
| Doxofylline and Glucose Injection | 国药准字H20030500 | 化学药品 | 注射剂 | 1/7/2021 | |
| Doxofylline and Glucose Injection | 国药准字H20143147 | 化学药品 | 注射剂 | 11/23/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||