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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/12 | Phase 1 | Withdrawn | |||
2024/01/03 | Phase 1 | Completed | LG Chem | ||
2023/07/17 | Phase 2 | Active, not recruiting | |||
2023/05/11 | Phase 1 | Recruiting | |||
2023/02/08 | Phase 2 | Completed | Oslo University Hospital | ||
2021/03/09 | Phase 2 | Completed | |||
2020/09/16 | Phase 2 | Recruiting | |||
2020/03/16 | Early Phase 1 | Withdrawn | |||
2020/02/13 | Early Phase 1 | UNKNOWN | |||
2020/02/06 | Phase 4 | Completed | Damanhour Teaching Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Purdue Pharmaceutical Products LP | 67781-251 | ORAL | 400 mg in 1 1 | 9/19/2011 | |
| Sun Pharmaceutical Industries Limited | 70095-017 | ORAL | 300 mg in 1 1 | 1/8/2024 | |
| PAI Holdings, LLC | 0121-4820 | ORAL | 80 mg in 15 mL | 8/11/2023 | |
| Rhodes Pharmaceuticals | 42858-700 | ORAL | 300 mg in 1 1 | 5/17/2023 | |
| Atlantic Biologicals Corps | 17856-0644 | ORAL | 80 mg in 15 mL | 9/28/2010 | |
| AvKARE | 42291-922 | ORAL | 300 mg in 1 1 | 4/13/2023 | |
| Carilion Materials Management | 68151-0667 | ORAL | 400 mg in 1 1 | 12/21/2015 | |
| Sun Pharmaceutical Industries Limited | 70095-018 | ORAL | 450 mg in 1 1 | 1/8/2024 | |
| Camber Pharmaceuticals, Inc. | 31722-078 | ORAL | 450 mg in 1 1 | 9/20/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0315 | ORAL | 200 mg in 1 1 | 5/25/2010 |
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 |
|---|---|---|---|---|---|
| NUELIN-SR 125 TABLET | SIN11399P | TABLET | 125 mg | 10/9/2000 | |
| APO-THEO LA TABLET 300 mg | SIN10159P | TABLET | 300 mg | 10/5/1998 | |
| APO-THEO LA TABLET 200 mg | SIN09668P | TABLET | 200 mg | 3/7/1998 | |
| NUELIN-SR 250 TABLET | SIN10679P | TABLET | 250 mg | 1/20/1999 | |
| APO-THEO LA TABLET 100 mg | SIN10158P | TABLET | 100 mg | 10/5/1998 | |
| NUELIN SYRUP 80 mg/15 ml | SIN02770P | SYRUP | 80 mg/15 ml | 5/9/1989 | |
| THEOLIN SR TABLET 250 mg | SIN03147P | TABLET, FILM COATED | 250 mg | 6/9/1989 | |
| THEOPHYLLINE TABLETS 100 mg | SIN03139P | TABLET | 100 mg | 6/2/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lysine Tneophyllinate Tablets | 国药准字H10970077 | 化学药品 | 片剂 | 8/20/2020 | |
| Theophylline Sodium Glycinate Sustained Release Tablets | 国药准字H20110102 | 化学药品 | 片剂 | 3/16/2021 | |
| Theophylline Sustained Release Capsules（Ⅱ） | 国药准字H10940034 | 化学药品 | 缓释制剂 | 3/2/2020 | |
| Theophylline Sustained Release Capsules（Ⅱ） | 国药准字H10940037 | 化学药品 | 缓释制剂 | 3/2/2020 | |
| Theophylline Sustained-release Capsules | 国药准字H20010413 | 化学药品 | 胶囊剂(缓释) | 11/7/2019 | |
| Theophylline Sustained-release Capsules | 国药准字H20030602 | 化学药品 | 胶囊剂(缓释) | 11/8/2019 | |
| Theophylline Sustained-release Capsules | 国药准字H10960320 | 化学药品 | 胶囊剂 | 8/5/2020 | |
| Theophylline Sustained-release Capsules | 国药准字H20030601 | 化学药品 | 胶囊剂(缓释) | 11/7/2019 | |
| Theophylline Sustained-release Capsules | 国药准字H10960284 | 化学药品 | 胶囊剂 | 4/9/2020 | |
| Theophylline Sustained-release Capsules | 国药准字H20010412 | 化学药品 | 胶囊剂(缓释) | 11/7/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NUELIN-SR TAB 250MG | N/A | N/A | N/A | 9/20/1991 | |
| NUELIN SR 300 TAB 300MG (INDIA) | N/A | N/A | N/A | 12/31/1999 | |
| NUELIN-SR 125 TAB 125MG S R WHITE | N/A | N/A | N/A | 5/5/1983 | |
| NUELIN SR 200 TAB 200MG (INDIA) | N/A | N/A | N/A | 12/31/1999 | |
| NUELIN SYRUP 80MG/15ML | N/A | N/A | N/A | 2/28/1983 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NUELIN SYRUP Theophylline 26.67mg/5mL oral liquid bottle. | 114785 | Medicine | A | 11/24/2004 | |
| NUELIN SR 300 theophylline 300mg tablet bottle | 59527 | Medicine | A | 5/16/1997 | |
| DBL AMINOPHYLLINE 250mg/10mL injection ampoule | 16355 | Medicine | A | 10/8/1991 | |
| Nuelin SR 200 theophylline 200mg Export Only | 115703 | Medicine | A | 1/18/2005 | |
| THEO-24 200mg capsules | 34070 | Proqualix Pty Ltd - in Administration | Medicine | A | 11/28/1991 |
| NUELIN Syrup theophylline 26.67mg/5mL bottle | 10576 | Medicine | A | 7/4/1991 | |
| NEULIN SR 200 theophylline 200mg tablet bottle | 59526 | Medicine | A | 5/16/1997 | |
| THEO-24 100mg capsules | 34025 | Proqualix Pty Ltd - in Administration | Medicine | A | 11/28/1991 |
| THEO-24 300mg capsules | 34075 | Proqualix Pty Ltd - in Administration | Medicine | A | 11/27/1991 |
| Nuelin Syrup 100 mL | 164051 | Medicine | A | 8/5/2009 |
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