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tonapofylline

Phase 3

Renal Insufficiency | Small molecule | Cardiovascular |Biogen Inc.|Last Updated: Sep 11, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

tonapofylline · 1 trial · 2 indications

Phase 3 1
NCT00709865Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal InsufficiencyRenal Insufficiency
COMPLETED420 Analytics
PHASE3COMPLETED
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Renal Insufficiency
NCT00709865420
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Study Endpoints

Primary Endpoints

Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
0-60 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL.03 mg/kg
2EXPERIMENTAL.15 mg/kg
3EXPERIMENTAL.3 mg/kg
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
tonapofyllineDRUGIV
PlaceboDRUGIV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites189

Inclusion Criteria: * Previous diagnosis of heart failure. * Must have ADHF, requiring hospitalization, with clinical evidence for volume overload Exclusion Criteria: * History of an allergic reaction to any xanthine-containing substance. * History of seizure * History of stroke * Myocardial infa...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaCzechiaFinlandFranceGermanyIndiaIsraelItalyNetherlandsPolandRomaniaRussiaSweden
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Frequently asked questions about tonapofylline

What is tonapofylline used for?

Tonapofylline is an investigational small molecule being studied for renal insufficiency in patients with acute decompensated heart failure (ADHF). It is administered intravenously and is being developed by Biogen Inc. (NASDAQ: BIIB). The drug is currently in Phase 3 clinical development.

How does tonapofylline work?

Tonapofylline is a small molecule being studied for its effects on renal function in patients with acute decompensated heart failure and renal insufficiency. The specific molecular target of tonapofylline has not been disclosed in the available clinical trial information.

Who is developing tonapofylline?

Tonapofylline is being developed by Biogen Inc., a biotechnology company traded on NASDAQ under the ticker BIIB. The drug is currently in Phase 3 clinical development for renal insufficiency in patients with acute decompensated heart failure.

What phase is tonapofylline in?

Tonapofylline is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its safety and tolerability in subjects with acute decompensated heart failure and renal insufficiency.

What clinical trials has tonapofylline been in?

Tonapofylline has been studied in a completed Phase 3 clinical trial registered as NCT00709865. This randomized, double-blind, placebo-controlled study enrolled 420 participants to assess the safety and tolerability of intravenous tonapofylline in subjects with acute decompensated heart failure and renal insufficiency.

Is tonapofylline the same as any other drug?

Tonapofylline is the drug name used in clinical trials and no alternative names have been reported. It is an investigational small molecule being developed by Biogen Inc. for renal insufficiency in patients with acute decompensated heart failure.