REVATIO (sildenafil citrate) · Viatris
Revatio is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise capacity and delay clinical worsening. It is also indicated for pediatric patients aged 1 to 17 years to improve exercise ability. In pediatric patients too young to perform standardized exercise testing, the drug is indicated to improve pulmonary hemodynamics thought to underlie improvements in exercise.
How REVATIO Works
Sildenafil is a selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE-5), the enzyme responsible for the degradation of cGMP in the pulmonary vasculature. By inhibiting PDE-5, sildenafil increases intracellular cGMP levels, resulting in the relaxation of pulmonary vascular smooth muscle and subsequent vasodilation of the pulmonary vascular bed. It also causes a lesser degree of vasodilation in the systemic circulation. Sildenafil is highly selective for PDE-5 compared to PDE-3 (involved in cardiac contractility), though its lower selectivity for PDE-6 (found in the retina) accounts for potential color vision abnormalities.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2005-06-03
- Patent Cliff
- 2030
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- FOR SUSPENSION, TABLET, SOLUTION
REVATIO Approval History
What REVATIO Treats
1 indicationsREVATIO is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
REVATIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in REVATIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications REVATIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to REVATIO
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05061368 | Pro00108944 | Ph 2 | recruiting | Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD |
| NCT04565925 | 20-0197 | Ph 2 | active not recruiting | Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries |
| NCT06178523 | RES/2024/1 | Ph 4 | completed | Cost-effective Treatment of Unexplained Infertility |
| NCT04898114 | Neb-Mag-2 | Ph 1, Ph 2 | recruiting | Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn |
| NCT01817751 results posted | MCC-14816 HM14816, NCI-2013-00705 | Ph 2 | completed | Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma |
| NCT04169191 SANE-02 | SANE-02 | Ph 1 | completed | Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia |
| NCT00871065 | 0165-08-FB | Ph 2 | withdrawn | Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm |
| NCT05846906 | REC-H-PhBSU-21015 | Ph 2, Ph 3 | completed | Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness |
| NCT03686813 results posted | Pro00100971 | Ph 2 | completed | Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention |
| NCT03417492 | 827103 | Ph 1 | terminated | Cerebrovascular Reactivity in American Football Players |
| NCT02060487 AFFILIATE results posted | A1481324 2013-004362-34, AFFILIATE | Ph 4 | terminated | Effects of Oral Sildenafil on Mortality in Adults With PAH |
| NCT01247805 | A1481293 EudraCT 2010-023521-38 | Ph 1 | completed | A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions |
| NCT01027117 | A1481275 | Ph 1 | completed | A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers |
| NCT01656798 | A1481313 | Ph 1 | completed | Food Effect Study For New Formulation |
| NCT00430716 results posted | A1481244 2006-006748-76 | Ph 4 | terminated | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. |
| NCT03598140 results posted | STU 032018-063 | Ph 2 | terminated | Sildenafil Treatment for Mild TBI |
| NCT02466802 | MCC-13-09812 HM20004297, NCI-2015-01101 | Ph 1 | completed | Study of Regorafenib and Sildenafil for Advanced Solid Tumors |
| NCT03766594 | SURPL | Ph 1 | completed | Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss |
| NCT01950923 | IRB00021729-1 NCI-2013-00988, P30CA012197 | Ph 1 | completed | Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer |
| NCT02620995 | CAAE 17663813.4.0000.5272 | Ph 4 | completed | Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction |
| NCT03431649 | TAshirley | Ph 4 | completed | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children |
| NCT02590536 | SFGR | Ph 3 | completed | A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction |
| NCT02129725 results posted | 110206-substudy | Ph 4 | completed | Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle. |
| NCT02628847 | 53515 | Ph 1 | terminated | Sildenafil and Stroke Recovery |
| NCT01347008 results posted | FAPESP 2011/00012-3 | Ph 3 | completed | Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis |
| NCT00862043 SIOVAC | FIBHGM-SIOVAC 2007-007033-40, EC07-90772 | Ph 4 | completed | Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease |
| NCT02845388 | Ainshams2015Omar | Ph 2 | completed | Sildenafil Citrate in Frozen Embryo Transfer |
| NCT01830790 results posted | Pro00042897 | Ph 2 | terminated | Effects of Sildenafil on Choroidal Thickness in AMD |
| NCT01219023 JADE | Pro00021480 | Ph 1 | completed | Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil |
| NCT01122264 results posted | 13085 H6D-EW-LVIJ | Ph 4 | completed | A Study in Patients With Erectile Dysfunction |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REVATIO FDA Label Details
Indications & Usage
FDA Label (PDF)Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ] . Pediatric Patients (1 to 17 Years Old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies ] . Adul...
REVATIO Patents & Exclusivity
Exclusivity
Track REVATIO with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment