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BG9928

Phase 3

Hepatic Impairment | Small molecule | Gastrointestinal |Biogen Inc.|Trials Updated: Sep 11, 2023

BG9928 development status

Highest phase Phase 3 (NCT00709865)
Phase scored for BIIBPhase 1
Registered trials 3 across 1 sponsor since Jul 2008

BG9928 target and mechanism

Molecular targetA1 receptor
Target classReceptor
ModalitySmall molecule

Also known as tonapofylline, Adentri

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment443

FDA Designations

No designations recorded

BG9928 clinical trials

BG9928 · 2 trials · 3 indications

Phase 3 1Phase 1 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 InsufficiencyUnlock trial analytics

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
The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function
1 week post dose
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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
BG9928DRUGOral 75 mg single dose
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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 BG9928

What is BG9928 used for in hepatic impairment?

BG9928 is an investigational small molecule that Biogen Inc. studied in people with hepatic impairment, a condition in which liver function is reduced. It was evaluated in a Phase 1 trial to assess its behavior in subjects with impaired liver function compared with healthy volunteers.

What does BG9928 target?

BG9928 targets the A1 receptor, a receptor class molecular target. By acting at this receptor, the small molecule is designed to interact with adenosine A1 receptor signaling. This receptor activity is the basis for its investigation in hepatic impairment.

Who is developing BG9928?

BG9928 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the clinical program for the drug, including the Phase 1 study conducted in the United States.

What phase is BG9928 in?

BG9928 is in Phase 1 development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of one completed trial, and no trials are currently active.

What clinical trials is BG9928 in?

BG9928 was studied in one Phase 1 trial, NCT00858156, titled "BG9928 in Subjects With Hepatic Impairment." The trial enrolled 23 participants in the United States, included healthy volunteers, and is now completed.

How was the BG9928 hepatic impairment trial designed?

The Phase 1 trial NCT00858156 was an uncontrolled study, meaning it did not use randomization or double blinding. It enrolled 23 participants aged 18 years and older of all sexes, included healthy volunteers, and was conducted in the United States.