THEO-24 (theophylline)
Theo-24 is an extended-release methylxanthine indicated for the chronic treatment of symptoms and reversible airflow obstruction associated with long-term lung conditions, including bronchial asthma, emphysema, and chronic bronchitis. It is used for the maintenance of airway patency and to reduce the airways' hyperresponsiveness to various respiratory stimuli; however, it is not intended for the treatment of acute bronchospasm.
How THEO-24 Works
While its exact mechanisms are not known with certainty, theophylline is believed to induce bronchodilation by inhibiting phosphodiesterase isozymes (primarily PDE III and, to a lesser extent, PDE IV), resulting in airway smooth muscle relaxation. It also exerts non-bronchodilator prophylactic effects by suppressing airway response to stimuli through molecular pathways distinct from PDE inhibition. Additionally,
Details
- Status
- Prescription
- First Approved
- 1983-08-22
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
THEO-24 Approval History
What THEO-24 Treats
4 indicationsTHEO-24 is approved for 4 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Emphysema
- Chronic Bronchitis
- Chronic Lung Disease
THEO-24 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in THEO-24's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications THEO-24 treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to THEO-24
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03029429 | IND 133103 | Ph 2 | active not recruiting | Theophylline Treatment for Pseudohypoparathyroidism |
| NCT04551170 | IND 133103 R01 | Ph 2 | active not recruiting | Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old |
| NCT05076682 Renaissance | 2107239-9 | Ph 2 | recruiting | Reverse Triple Negative Immune Resistant Breast Cancer |
| NCT05947643 results posted | 202209062 | Ph 2 | completed | Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3) |
| NCT02479451 HONORR results posted | 2015P001231 | Ph 2 | completed | Helping Olfaction and Nutrition On Renal Replacement |
| NCT06189404 | LG-GDCL013 | Ph 1 | completed | Effect of Tigulixostat on the Pharmacokinetics of Theophylline |
| NCT03718403 | Theophylline in PHP | Ph 4 | recruiting | Effect of Theophylline in Pseudohypoparathyroidism |
| NCT03990766 SCENT results posted | 201901107 | Ph 2 | completed | Smell Changes & Efficacy of Nasal Theophylline |
| NCT02261727 TASCS results posted | TGI-Resp-01 1033117 | Ph 4 | completed | Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study |
| NCT01263106 results posted | 12594 H9P-EW-LNCE | Ph 1 | completed | A Study of LY2216684 and Theophylline in Healthy Subjects |
| NCT02080078 | Theophylline 1.0 | Ph 1 | terminated | A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline |
| NCT02537691 | MB29599 2015-000742-35 | Ph 4 | completed | Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers |
| NCT02340520 results posted | 14-032-3 | Ph 3 | completed | Enhancement of Corticosteroid Efficacy in COPD |
| NCT01599871 ASSET | 1559-F-447 | Ph 3 | completed | Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease |
| NCT02463409 results posted | IRB 150497 | Ph 2 | completed | Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy) |
| NCT01684683 | theophylline in NCFB | Ph 4 | completed | The Effect of Theophylline in the Treatment of Bronchiectasis |
| NCT01769898 | theophylline in bronchiectasis | Ph 4 | completed | The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis |
| NCT01799161 | 20110847 | Ph 1 | withdrawn | Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer |
| NCT01601132 results posted | MPC-004-11-4001 U1111-1141-7355 | Ph 4 | completed | Drug Interaction Study of Colchicine and Theophylline |
| NCT01017939 | CR017128 COU-AA-015 | Ph 1 | completed | A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT00983905 results posted | MPC-004-08-1010 | Ph 1 | completed | Drug-Drug Interaction Study of Colchicine and Theophylline |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
THEO-24 FDA Label Details
Indications & Usage
THEO-24 is indicated for the treatment of Asthma; Emphysema; Chronic Bronchitis; Chronic Lung Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.