Truphylline

(aminophylline)

ApprovedSmall molecule

Aminophylline is used to treat breathing problems like asthma and chronic obstructive pulmonary disease (COPD) by relaxing the muscles around the airways to make breathing easier.[2] Truphylline is currently approved and in use across 12 indications[4].[1]

Truphylline is one of 367 small molecule programs targeting Asthma. It is currently in Approved.

Indications

Total Trials

Active Trials

366

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AsthmaActive, not recruiting

Airway ObstructionActive, not recruiting

Urinary Bladder CancerApproved

Altitude SicknessApproved

Pulmonary Arterial HypertensionApproved

Kidney TransplantActive, not recruiting

ARTUnknown status

ToxicityNot yet recruiting

Acute Myocardial InfarctionCompleted

Kidney DiseaseCompleted

AsthmaApproved

Active, not recruiting

Airway ObstructionApproved

Active, not recruiting

Urinary Bladder CancerApproved

Approved

Altitude SicknessApproved

Approved

Pulmonary Arterial HypertensionApproved

Approved

Kidney TransplantPreclinical

Active, not recruiting

ARTPreclinical

Unknown status

ToxicityPhase 3

Not yet recruiting

Acute Myocardial InfarctionApproved

Completed

Kidney DiseaseApproved

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Truphylline

TThe Searle Company Limited Pakistan

Approved

2 2

Celexa

AbbVie

Preclinical

1 3

Arcoxia

Novartis

Preclinical

—4

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 5

DUPIXENT

Regeneron

Preclinical

1 6

Paracetamol

GSK

Preclinical

1 7

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 8

Aclidinium Bromide

Atrovent

2 10

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2/3Not yet recruiting

Toxicity

NCT06196853

Clinical

Trials by Indication[1]

Headache2 trials

Postdural Puncture Headache Relief With Aminophylline and SPGB

Completed·—·Phase 4·NCT05552404·75 enrolled

Aminophylline for Patients With Post-Dural Puncture Headache

Completed·TThe First Affiliated Hospital of Zhengzhou University·Phase 3·NCT02522013·126 enrolled

Asthma2 trials

Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma

Unknown status·UUniversity of British Columbia·N/A·NCT03296579·100 enrolled

A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics

Terminated·RRoyal Brompton & Harefield NHS Foundation Trust··NCT02270827·5 enrolled

Acute Kidney Injury2 trials

Preventing Acute Kidney Injury (AKI) in Pediatric Patients

Unknown status·LLe Bonheur Children's Hospital·Phase 3·NCT03897335·80 enrolled

Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Completed·SStanford University·N/A·NCT01245595·144 enrolled

Progesterone1 trial

Progesterone and Aminophylline for the Prevention of Preterm Labour

Unknown status·SSt Stephens Aids Trust·Phase 1·NCT03152942·70 enrolled

Critically Ill1 trial

Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults

Unknown status·UUniversity of Malaya·Phase 2/3·NCT05933642·132 enrolled

17 more indications

Cardiac Arrest1 trial

Aminophylline in Bradyasystolic Cardiac Arrest

Completed·VVancouver General Hospital·Phase 2·NCT00312273·966 enrolled

Myocardial Infarction1 trial

Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients

Withdrawn·NNational Institute of Cardiovascular Diseases, Pakistan·Phase 4·NCT05666219

Kidney Transplant1 trial

Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant

Completed·SStanford University·N/A·NCT01759862·50 enrolled

Bladder Cancer1 trial

Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer

Completed·UUniversity of Virginia·Phase 1·NCT01240824·3 enrolled

Side Effects1 trial

Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

Terminated·RRush University Medical Center·Phase 4·NCT01250496·248 enrolled

Kidney Disease1 trial

Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging

Completed·RRush University Medical Center·Phase 4·NCT01336140·300 enrolled

Target-controlled Infusion1 trial

Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Burst Suppression Occurence

Completed·UUniversity of Padova··NCT06134037·32 enrolled

Toxicity1 trial

Prevention of Cisplatin-induced Nephrotoxicity

Not yet recruiting·MMahidol University·Phase 2/3·NCT06196853·24 enrolled

Oral1 trial

The Safety Evaluation of Aminophylline and Ambrisentan When Administered Orally Alone and in Combination to Healthy Volunteers

Completed·TThies Schroeder·Phase 1·NCT01530464·18 enrolled

Preoperative1 trial

The Effect of Preoperative Aminophylline

Unknown status·—·Phase 1·NCT04151381·45 enrolled

Acute Myocardial Infarction1 trial

Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Completed·OOspedale Misericordia e Dolce·Phase 4·NCT01594489·250 enrolled

Altitude1 trial

A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude

Completed·RRobert J Noveck, M.D.·Phase 1·NCT01794078·92 enrolled

Function1 trial

Effects of Aminophylline on Renal Function and Urine Volume of AKI Patient

Unknown status·SShanghai Jiao Tong University Affiliated Sixth People's Hospital·Phase 1·NCT02983422·60 enrolled

LAM1 trial

Safety Evaluation of Aminophylline and Methazolamide

Completed·PPoudre Valley Health System·Phase 1·NCT01587027·16 enrolled

Hypoxia1 trial

Rapid Acclimatization to Hypoxia at Altitude

Completed·—·Phase 1/2·NCT01702025·41 enrolled

ART1 trial

Adenosine Activity in Producing Venoarteriolar Reflexes

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01280071

Cardiac Surgical Procedures1 trial

Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures

Recruiting·—·N/A·NCT07348510·106 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

AMINOPHYLLIN

NDA NDA002386

Apr 2, 1982

SOMOPHYLLIN

NDA NDA018232

Dec 12, 1984

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

NDA NDA018924

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for aminophylline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Truphylline drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — aminophylline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for aminophylline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018924). U.S. Food & Drug Administration.
[6]
SEC EDGAR — The Searle Company Limited Pakistan company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Truphylline

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Headache2 trials

Asthma2 trials

Acute Kidney Injury2 trials

Progesterone1 trial

Critically Ill1 trial

Cardiac Arrest1 trial

Myocardial Infarction1 trial

Kidney Transplant1 trial

Bladder Cancer1 trial

Side Effects1 trial

Kidney Disease1 trial

Target-controlled Infusion1 trial

Toxicity1 trial

Oral1 trial

Preoperative1 trial

Acute Myocardial Infarction1 trial

Altitude1 trial

Function1 trial

LAM1 trial

Hypoxia1 trial

ART1 trial

Cardiac Surgical Procedures1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News