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balapiravir

Phase 1

Dengue | Small molecule | Infectious Disease |Roche Holding AG|Trials Updated: Nov 2, 2016

balapiravir target and mechanism

ModalitySmall molecule

Also known as balapiravir [RO4588161]

Success Probability

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Market & Valuation

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Trial Design

Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

balapiravir clinical trials

balapiravir · 1 trial · 1 indication

Phase 1 1
NCT01096576A Study of Balapiravir in Patients With Dengue Virus InfectionDengue
COMPLETED64 Analytics
PHASE1COMPLETED
A Study of Balapiravir in Patients With Dengue Virus Infection
DengueUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability: Adverse events, laboratory parameters, vital signs
days 1-7 and on follow-up days 14, 28 and 84

Secondary Endpoints

Viral load
days 1-7 and 14
Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites
multiple sampling days 1 and 5
Body temperature
days 1-7 and on follow-up days 14, 28 and 84
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Study Design & Arms

MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
balapiravir [RO4588161]DRUGsequential cohorts receiving doses orally twice daily for 5 days
placeboDRUGorally twice daily for 5 days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * male patients, 18-65 years of age * dengue virus infection (confirmed by NS1 strip test) with symptom onset \</=48 hours before first study drug administration * patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiv...

Countries:Vietnam
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Competitive Landscape -Dengue 12 trials

Top 2 of 5 competitors

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Frequently asked questions about balapiravir

What is balapiravir?

Balapiravir is an investigational small molecule antiviral developed by Roche Holding AG for dengue virus infection. It has been studied in a single Phase 1 clinical trial conducted in Vietnam. Balapiravir is not an approved medicine and remains in clinical development.

What is balapiravir used for?

Balapiravir was studied for the treatment of dengue virus infection. The only recorded clinical trial of balapiravir enrolled 64 adult male patients with dengue in Vietnam. Because balapiravir is investigational, it is not an approved treatment for dengue or any other condition.

Who makes balapiravir?

Balapiravir is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical research of balapiravir in dengue virus infection.

What phase is balapiravir in?

Balapiravir is in Phase 1 development. The single registered trial, NCT01096576, was a Phase 1 study in patients with dengue virus infection. That trial is completed, and no active trials of balapiravir are currently listed.

What clinical trials is balapiravir in?

Balapiravir has been evaluated in one clinical trial, NCT01096576, titled A Study of Balapiravir in Patients With Dengue Virus Infection. It was a Phase 1, placebo-controlled, double-blind study that enrolled 64 adult male patients in Vietnam and is now completed.

Is balapiravir the same as RO4588161?

Yes, balapiravir is also known as RO4588161, which is Roche's internal compound designation for the same investigational dengue antiviral. Both names refer to the identical small molecule drug candidate developed by Roche Holding AG.