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ADS-8902

Phase 2

Influenza | Small molecule | Infectious Disease |Supernus Pharmaceuticals, Inc.|Last Updated: Apr 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

ADS-8902 · 1 trial · 1 indication

Phase 2 1
NCT00979251Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised SubjectsInfluenza
COMPLETED2 Analytics
PHASE2COMPLETED
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Influenza
NCT009792512
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Study Endpoints

Primary Endpoints

Time to clearing of viral shedding
Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary Endpoints

Time to alleviation of influenza clinical symptoms
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
Baseline, Days 2, 4, 6, 8, 10, 15, 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ADS-8902EXPERIMENTALAmantadine and Ribavirin administered with Oseltamivir phosphate
ComparatorACTIVE_COMPARATOROseltamivir Phosphate

Interventions

NameTypeDescription
Oseltamivir PhosphateDRUGOseltamivir Phosphate, q8h
ADS-8902DRUGAmantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
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Eligibility Criteria

Age Range1 Year to 65 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Confirmed influenza A by rapid antigen testing * Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive * Cl...

Countries:United StatesAustraliaCanadaNetherlandsSingapore
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about ADS-8902

What is ADS-8902 used for?

ADS-8902 is an investigational small molecule being developed for the treatment of influenza. It is currently in Phase 2 clinical development as a potential antiviral therapy for this infectious disease.

Who is developing ADS-8902?

ADS-8902 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN.

What phase is ADS-8902 in?

ADS-8902 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of influenza.

What clinical trials is ADS-8902 in?

ADS-8902 has been studied in a Phase 2 clinical trial with the identifier NCT00979251. This completed trial evaluated oral triple combination antiviral drug therapy for influenza A in immunocompromised subjects.

Is ADS-8902 the same as other antiviral drugs?

ADS-8902 is a distinct investigational small molecule. It has been studied as part of a triple combination antiviral therapy, but it is not the same as other approved influenza treatments.