Product Description
Sildenafil is a medication used in the management and treatment of erectile dysfunction and pulmonary arterial hypertension. It is in the phosphodiesterase-5 inhibitor (PDE5-I) class of medications. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK558978/)
Mechanisms of Action: PDE5 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Hypertension | Hypertension, Pulmonary | Hypertension | Hypertension, Pulmonary | Erectile Dysfunction
Known Adverse Events: Insomnia | Erythema | Epistaxis | Rhinitis | Dyspnea | Dyspepsia | Flushing | Headache | Back Pain | Dizziness | Pain Unspecified | Myalgia
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Nigeria, United Kingdom, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Erectile Dysfunction|Hypertension, Pulmonary
Phase 2: Asphyxia Neonatorum|Bronchopulmonary Dysplasia|Cerebral Small Vessel Diseases|Cerebrovascular Disorders|Fetal Distress|Idiopathic Pulmonary Fibrosis
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| UAB-300012809 | P2 |
Not yet recruiting |
Asphyxia Neonatorum|Fetal Distress |
2026-05-31 |
|
| SIL02 | P2 |
Recruiting |
Bronchopulmonary Dysplasia |
2025-02-25 |
|
| 20US-SDF15 | P3 |
Active, not recruiting |
Erectile Dysfunction |
2024-12-01 |
|
| SST-6006-015 | P1 |
Recruiting |
Healthy Volunteers |
2024-04-01 |