Theo-Dur

(Theophylline)

ApprovedSmall molecule

Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD) by relaxing the muscles around the airways to make breathing easier. It can also help reduce symptoms like wheezing and shortness of breath.[2] Theo-Dur is currently approved and in use across 18 indications[4].[1]

Theo-Dur is one of 363 small molecule programs targeting Syncope. It is currently in Approved.

Indications

Total Trials

Active Trials

362

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

SyncopeActive, not recruiting

Chronic BronchitisActive, not recruiting

Airway ObstructionActive, not recruiting

AsthmaActive, not recruiting

Pseudohypoparathyroidism Type 1aApproved

LeukemiaApproved

Lung CancerApproved

Congenital Heart DiseaseApproved

NephropathyActive, not recruiting

PseudohypoparathyroidismActive, not recruiting

SyncopePreclinical

Active, not recruiting

Chronic BronchitisApproved

Active, not recruiting

Airway ObstructionApproved

Active, not recruiting

AsthmaApproved

Active, not recruiting

Pseudohypoparathyroidism Type 1aApproved

Approved

LeukemiaApproved

Approved

Lung CancerApproved

Approved

Congenital Heart DiseaseApproved

Approved

NephropathyApproved

Active, not recruiting

PseudohypoparathyroidismPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Theo-Dur

Pfizer

Approved

1 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Pseudohypoparathyroidism

NCT03029429

Phase 2Active, not recruiting

Hypoparathyroidism

NCT04551170

Q1 2027

Phase 2Recruiting

Breast Cancer

NCT05076682

Q2 2032

Post-ApprovalRecruiting

Hypoparathyroidism

NCT03718403

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease5 trials

Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Completed·HHospital Universitari Son Dureta·N/A·NCT00671151·35 enrolled

The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists

Unknown status·—·N/A·NCT00893009·30 enrolled

Theophylline in Chronic Obstructive Pulmonary Disease

Completed·OOttawa Hospital Research Institute·Phase 2/3·NCT00299858·24 enrolled

Show 2 more trials

Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study

Completed·TThe George Institute·Phase 4·NCT02261727·1,670 enrolled

Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease

Completed·—·Phase 3·NCT01599871·70 enrolled

Asthma4 trials

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00252785·340 enrolled

DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00252863·1,600 enrolled

Rosiglitazone Versus Theophylline in Asthmatic Smokers

Completed·UUniversity of Glasgow·Phase 2/3·NCT00119496·79 enrolled

Show 1 more trial

Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Completed· Roche logo

Roche·Phase 4·NCT02537691·483 enrolled

Interaction3 trials

Drug-Drug Interaction Study of Colchicine and Theophylline

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983905·30 enrolled

Drug Interaction Study of Colchicine and Theophylline

Completed· Takeda logo

Takeda·Phase 4·NCT01601132·30 enrolled

Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00779259·24 enrolled

Efficacy2 trials

Enhancement of Corticosteroid Efficacy in COPD

Completed·UUConn Health·Phase 3·NCT02340520·13 enrolled

Smell Changes & Efficacy of Nasal Theophylline

Completed·WWashington University School of Medicine·Phase 2·NCT03990766·27 enrolled

COVID-192 trials

Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3)

Completed·WWashington University School of Medicine·Phase 2·NCT05947643·77 enrolled

Smell in Covid-19 and Efficacy of Nasal Theophylline

Completed·WWashington University School of Medicine·Phase 2·NCT04789499·51 enrolled

25 more indications

Tics2 trials

Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02273440·16 enrolled

Effect of Tigulixostat on the Pharmacokinetics of Theophylline

Completed·LLG Chem·Phase 1·NCT06189404·24 enrolled

Function2 trials

Enhancement of in-Vitro GC Function in Patients With COPD

Completed·IImperial College London·Phase 2·NCT00241631·49 enrolled

The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

Unknown status·—·N/A·NCT03894189·70 enrolled

Gene Polymorphism2 trials

Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

Completed·XXiaoGuang Zou·N/A·NCT03015090·110 enrolled

Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

Completed·ZZhujiang Hospital·N/A·NCT02001935·102 enrolled

Hypoparathyroidism2 trials

Effect of Theophylline in Pseudohypoparathyroidism

Recruiting·MMassachusetts General Hospital·Phase 4·NCT03718403·100 enrolled

Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old

Active, not recruiting·VVanderbilt University Medical Center·Phase 2·NCT04551170·34 enrolled

Bronchiectasis2 trials

The Effect of Theophylline in the Treatment of Bronchiectasis

Completed·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01684683·100 enrolled

The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis

Completed·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01769898·50 enrolled

Nephropathy2 trials

Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy

Completed·TTechnical University of Munich·Phase 4·NCT00492518·254 enrolled

Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy

Unknown status·IIsfahan University of Medical Sciences·Phase 2/3·NCT02088502·96 enrolled

Age1 trial

Digital Image Correlation in Right Ventricular Evaluation

Completed·TTampere University Hospital·N/A·NCT03115294·20 enrolled

Albright hereditary osteodystrophy1 trial

Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)

Completed·VVanderbilt University Medical Center·Phase 2·NCT02463409·6 enrolled

Breast Cancer1 trial

Reverse Triple Negative Immune Resistant Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05076682·80 enrolled

Apnea of Prematurity1 trial

CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

Completed·UUniversity of Manitoba·Phase 2/3·NCT01066728·87 enrolled

Montelukast1 trial

Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

Completed·OOrganon and Co·Phase 4·NCT00756418·84 enrolled

Non-Small Cell Lung Cancer1 trial

Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer

Withdrawn·EEckhard Podack·Phase 1·NCT01799161

Ultrasound1 trial

Diaphragmatic Ultrasound With Theophylline Therapeutic Trials

Unknown status·—·Phase 1·NCT04269187·46 enrolled

Syncope1 trial

Theophylline for Low Adenosine Syncope

Completed·CCentro Prevenzione Malattie Cardiovascolari N. e V. Corbella··NCT03803215·77 enrolled

Shortness of Breath1 trial

Theophylline in Treating Cancer Patients With Shortness of Breath

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00003684·3 enrolled

Pregnancy1 trial

NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000578

Anosmia1 trial

The Effect of Oral Theophylline on Traumatic Anosmia

Completed·TTaichung Veterans General Hospital·Phase 4·NCT07171021·158 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01017939·34 enrolled

Treatment1 trial

Sphenopalatine Blockade Versus Clinical Treatment

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT04148846·45 enrolled

Rhinitis1 trial

Theophylline in Rhinitis

Completed·UUniversity of East Anglia·Phase 2·NCT01132781·28 enrolled

Fontan1 trial

Theophylline Effects in the Fontan Circulation

Completed·OOslo University Hospital·Phase 2·NCT05717049·10 enrolled

Pilot Study1 trial

A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial

Completed·UUniversity of California, San Diego·Phase 4·NCT01696214·20 enrolled

Chronic Lymphocytic Leukemia1 trial

Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00003808

Pseudohypoparathyroidism1 trial

Phase 2 Study of Theophylline Treatment for Pseudohypoparathyroidism

Active, not recruiting·VVanderbilt University Medical Center·Phase 2·NCT03029429·29 enrolled

Unspecified3 trials

Helping Olfaction and Nutrition On Renal Replacement

Completed·MMassachusetts General Hospital·Phase 2·NCT02479451·7 enrolled

A Study of LY2216684 and Theophylline in Healthy Subjects

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01263106·21 enrolled

A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline

Terminated·AAHS Cancer Control Alberta·Phase 1·NCT02080078·15 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 26, 1982

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA018649

Nov 7, 1984

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA019083

Nov 7, 1984

THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA019212

Dec 14, 1984

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA019211

Aug 14, 1992

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA019826

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Theophylline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Theo-Dur drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Theophylline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Theophylline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019826). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 4 Inhibitor; Adenosine Receptor Antagonist; Phosphodiesterase 3 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Theo-Dur

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2032

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease5 trials

Asthma4 trials

Interaction3 trials

Efficacy2 trials

COVID-192 trials

Tics2 trials

Function2 trials

Gene Polymorphism2 trials

Hypoparathyroidism2 trials

Bronchiectasis2 trials

Nephropathy2 trials

Age1 trial

Albright hereditary osteodystrophy1 trial

Breast Cancer1 trial

Apnea of Prematurity1 trial

Montelukast1 trial

Non-Small Cell Lung Cancer1 trial

Ultrasound1 trial

Syncope1 trial

Shortness of Breath1 trial

Pregnancy1 trial

Anosmia1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

Treatment1 trial

Rhinitis1 trial

Fontan1 trial

Pilot Study1 trial

Chronic Lymphocytic Leukemia1 trial

Pseudohypoparathyroidism1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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