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Stendra (AVANAFIL)

Vivus Llc · FDA-approved approved Small molecule Quality 50/100

Stendra works by inhibiting an enzyme that breaks down a molecule called cyclic GMP, allowing blood vessels to relax and improve blood flow to the penis.

Stendra (Avanafil) is a phosphodiesterase 5 inhibitor, a small molecule developed by VIVUS and currently owned by Vivus LLC. It targets cGMP-specific 3',5'-cyclic phosphodiesterase, which is involved in the regulation of smooth muscle tone in the corpus cavernosum. Stendra is FDA-approved for the treatment of impotence and is available as a generic medication. As an off-patent medication, it is no longer protected by active patents. Key safety considerations include potential interactions with nitrates and caution in patients with cardiovascular disease.

At a glance

Generic nameAVANAFIL
SponsorVivus Llc
Drug classPhosphodiesterase 5 Inhibitor [EPC]
TargetcGMP-specific 3',5'-cyclic phosphodiesterase
ModalitySmall molecule
Therapeutic areaHematology
PhaseFDA-approved
First approval2012

Mechanism of action

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Avanafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.Studies in vitro have shown that avanafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (greater than 100-fold for PDE6; greater than 1,000-fold for PDE4, PDE8 and PDE10; greater than 5,000-fold for PDE2 and PDE7; greater than 10,000-fold for PD

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results