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Viagra

Phase 4FDA approved 1998

Erectile Dysfunction | Small molecule | Other |Viatris Inc.|Trials Updated: Feb 1, 2021

Viagra development status

FDA approval Mar 27, 1998
Approval holderViatris
ApplicationNDA020895
Highest phase Phase 4 (NCT00143221)
Phase scored for VTRSPhase 1
Registered trials 25 across 4 sponsors since Sep 2005

Label indication VIAGRA is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 ) FDA label

Viagra target and mechanism

ModalitySmall molecule

Also known as sildenafil citrate

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment69

FDA Designations

No designations recorded

Viagra clinical trials

Viagra · 2 trials · 2 indications

Phase 1 2
NCT01737203Bioequivalence Study For Orally-Disintegrating Tablet Of SildenafilHealthy
COMPLETED53 Analytics
NCT00950404Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral TabletHealthy Volunteers
COMPLETED16 Analytics
PHASE1COMPLETED
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Healthy
NCT0173720353
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PHASE1COMPLETED
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Healthy Volunteers
NCT0095040416
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Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
AUC0-T and Cmax of sildenafil
1 month

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ViagraACTIVE_COMPARATOROral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions
ODT without waterEXPERIMENTALSildenafil ODT 50 mg without water as a single oral dose under fasted conditions
ODT with waterEXPERIMENTALSildenafil ODT 50 mg with water as a single oral dose under fasted conditions
Viagra 50 mg tablet, administered with water.ACTIVE_COMPARATOR -
Formulation B ODT tablet 50 mg, administered without water.EXPERIMENTAL -
Formulation C ODT tablet 50 mg, administered without water.EXPERIMENTAL -
Formulation D ODT tablet 50 mg, administered without water.EXPERIMENTAL -

Interventions

NameTypeDescription
ViagraDRUG50 mg tablet on Day 1 of each period
sildenafil ODTDRUG50 mg tablet on Day 1 of each period
Viagra 50 mg tabletDRUGCommercial tablet, 50 mg, single dose administered with water
Formulation B ODT tablet 50 mgDRUGOral disintegrating tablet (ODT), 50 mg, single dose administered without water
Formulation C ODT tablet 50 mgDRUGODT, 50 mg, single dose administered without water
Formulation D ODT tablet 50 mgDRUGODT, 50 mg, single dose, administered without water
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Eligibility Criteria

Age Range20 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male subjects between the ages of 20 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Baseline orthostatic hypotension defined as a \>=20 mm Hg reduction in systolic blood pressure ...

Countries:JapanUnited States
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