Overview
A methylxanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Mechanistically, theophylline acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. Theophylline is marketed under several brand names such as Uniphyl and Theochron, and it is indicated mainly for asthma, bronchospasm, and COPD.
Indication
For the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, such as emphysema and chronic bronchitis.
Associated Conditions
- Asthma
- Bronchitis
- Bronchoconstriction
- Bronchospasm
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic bronchial inflammation
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/12/20 | Phase 1 | Completed | |||
2010/05/28 | Phase 2 | Completed | |||
2010/02/10 | Phase 2 | Completed | |||
2009/11/23 | Phase 1 | Completed | |||
2009/09/24 | Phase 1 | Completed | |||
2009/05/05 | Not Applicable | UNKNOWN | |||
2008/10/24 | Phase 1 | Completed | |||
2008/09/22 | Phase 4 | Completed | |||
2008/05/05 | Not Applicable | Completed | Hospital Universitari Son Dureta | ||
2008/03/13 | Phase 2 | Completed | Pulmagen Therapeutics |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Carilion Materials Management | 68151-4210 | ORAL | 600 mg in 1 1 | 11/8/2014 | |
| Golden State Medical Supply, Inc. | 51407-318 | ORAL | 400 mg in 1 1 | 1/31/2024 | |
| Tris Pharma Inc | 27808-033 | ORAL | 80 mg in 15 mL | 9/17/2018 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-380 | ORAL | 400 mg in 1 1 | 6/30/2019 | |
| Nostrum Laboratories, Inc. | 29033-002 | ORAL | 600 mg in 1 1 | 1/21/2020 | |
| PAI Holdings, LLC | 0121-0820 | ORAL | 80 mg in 15 mL | 8/11/2023 | |
| Endo Pharmaceuticals, Inc. | 52244-400 | ORAL | 400 mg in 1 1 | 8/30/2017 | |
| Marlex Pharmaceuticals Inc | 10135-604 | ORAL | 80 mg in 15 mL | 10/25/2019 | |
| Alembic Pharmaceuticals Limited | 46708-025 | ORAL | 300 mg in 1 1 | 1/11/2023 | |
| Bionpharma Inc., | 69452-267 | ORAL | 300 mg in 1 1 | 10/12/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Theophylline Sustained-release Tablets | 国药准字H20103796 | 化学药品 | 片剂 | 9/28/2021 | |
| Theophylline Sustained-release Tablets | 国药准字H12020152 | 化学药品 | 片剂 | 9/24/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H22022434 | 化学药品 | 片剂(缓释) | 4/25/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H44023791 | 化学药品 | 片剂(缓释) | 12/5/2019 | |
| Theophylline Sustained-release Tablets | 国药准字H20065702 | 化学药品 | 片剂 | 6/10/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H21020004 | 化学药品 | 片剂(缓释) | 5/12/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H20033006 | 化学药品 | 片剂 | 12/4/2019 | |
| Theophylline Sustained-release Tablets | 国药准字H37020529 | 化学药品 | 片剂 | 3/12/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H22023973 | 化学药品 | 片剂(缓释) | 6/10/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H19994050 | 化学药品 | 片剂 | 3/25/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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