NDAORALFILM
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
VYBRIQUE (sildenafil citrate) by Viatris (2) is pde-5 in the smooth muscle of the pulmonary vasculature, where pde-5 is responsible for degradation of cgmp. First approved in 2025.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYBRIQUE (sildenafil citrate) is an oral phosphodiesterase-5 (PDE-5) inhibitor approved in December 2025 for pulmonary arterial hypertension (PAH). It works by inhibiting PDE-5 in pulmonary vascular smooth muscle, increasing cGMP levels and promoting vasodilation of the pulmonary vascular bed. The drug demonstrates approximately 4,000-fold selectivity for PDE-5 over PDE3, minimizing cardiac contractility effects.
Launch7.5 years to LOE
Very recent launch (Q4 2025) with zero current linked job postings; team building and commercial infrastructure scaling likely underway.
Mechanism of Action
PDE-5 in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form
Started Jan 2021
0Healthy
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
Started Jan 2014
30 enrolled
Healthy
Study of Sildenafil Citrate on Insulin Resistance in African American
Started Apr 2011
46 enrolled
Metabolic SyndromeObesity
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Started Jan 2010
47 enrolled
Erectile Dysfunction
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
Started Sep 2004
76 enrolled
Pre-eclampsia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.