Product Description
Tadalafil (Cialis) is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men. Tadalafil (Adcirca) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow more easily. (Sourced from: https://medlineplus.gov/druginfo/meds/a604008.html)
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 | Prostatic Hyperplasia
Known Adverse Events: Headache | Back Pain | Pain Unspecified | Myalgia | Dyspepsia | Flushing
Company: Eli Lilly
Company Location: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Georgia, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey, United States, Unknown Location
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Erectile Dysfunction|Familial Primary Pulmonary Hypertension|Hypertension, Pulmonary
Phase 2: Colorectal Cancer
Phase 1: Alzheimer Disease|Healthy Volunteers|Prostatic Hyperplasia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| P-002-2020 | P1 |
Not yet recruiting |
Erectile Dysfunction |
2025-08-30 |
21% |
| C1B03967 | P1 |
Completed |
Healthy Volunteers |
2024-06-03 |
|
| C1B03346 | P1 |
Completed |
Healthy Volunteers |
2024-05-31 |
|
| 2014-004786-25 | P3 |
Active, not recruiting |
Hypertension, Pulmonary |
2024-03-05 |