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FST-100

Phase 2

Acute Adenoviral Conjunctivitis | Small molecule | Ophthalmology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 25, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment176

FDA Designations

No designations recorded

Clinical trial landscape

FST-100 · 2 trials · 2 indications

Phase 2 2
NCT01461954FST-100 in the Treatment of Acute Viral ConjunctivitisAcute Viral Conjunctivitis
COMPLETED132 Analytics
NCT01470664FST-100 in the Treatment of Acute Adenoviral ConjunctivitisAcute Adenoviral Conjunctivitis
COMPLETED176 Analytics
PHASE2COMPLETED
FST-100 in the Treatment of Acute Viral Conjunctivitis
Acute Viral ConjunctivitisUnlock trial analytics
PHASE2COMPLETED
FST-100 in the Treatment of Acute Adenoviral Conjunctivitis
Acute Adenoviral ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical resolution of acute viral conjunctivitis
6-7 days
Adenoviral eradication and clinical resolution of the infection
6-7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FST-100EXPERIMENTAL -
FST-100 VehiclePLACEBO_COMPARATOR -
FST-100 (Component #1)EXPERIMENTAL -

Interventions

NameTypeDescription
FST-100DRUGFST-100
FST-100 VehicleDRUGFST-100 Vehicle
FST-100 (Component #1)DRUG0.6% PVP-Iodine ophthalmic solution alone
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye Exclusion Criteria: * Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

Countries:United StatesBrazilIndia
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Frequently asked questions about FST-100

What is FST-100 used for?

FST-100 is an investigational small molecule being developed for the treatment of acute adenoviral conjunctivitis and acute viral conjunctivitis, which are eye infections causing inflammation of the conjunctiva. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes FST-100?

FST-100 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the Tokyo Stock Exchange under the ticker TAK. The drug is in Phase 2 clinical trials for acute viral and adenoviral conjunctivitis.

What phase is FST-100 in?

FST-100 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for acute viral conjunctivitis and one for acute adenoviral conjunctivitis. The drug remains investigational and has not received regulatory approval.

What clinical trials is FST-100 in?

FST-100 has been studied in two completed Phase 2 trials: NCT01461954 for acute viral conjunctivitis with 132 participants in the United States and Brazil, and NCT01470664 for acute adenoviral conjunctivitis with 176 participants in the United States and India. Both trials were randomized, double-blind, and placebo-controlled.

How does FST-100 work?

FST-100 is a small molecule designed to treat viral conjunctivitis, but its specific molecular target has not been disclosed. The drug is being evaluated for its ability to reduce the duration and severity of symptoms in patients with acute adenoviral or viral conjunctivitis.