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: *
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: None
Known Adverse Events: None
Company: Eli Lilly
Company Location: Eastern America
Company CEO: David A. Ricks
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belarus, Belgium, Bulgaria, China, Denmark, Hungary, India, Japan, Korea, Poland, Russia, South Africa, Taiwan, Ukraine, United States
Active Clinical Trial Count: 15
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Erectile Dysfunction|Hypertension, Pulmonary|Prostatic Hyperplasia
Phase 2: Cerebral Small Vessel Diseases|Ischemic Stroke
Phase 1: Alzheimer Disease|Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06805513 |
AUT16661 | P3 |
Recruiting |
Erectile Dysfunction |
2026-01-31 |
15% |
2025-02-26 |
Primary Endpoints|Treatments|Trial Status |
NCT04947631 |
DKF-313-P3 | P3 |
Completed |
Prostatic Hyperplasia |
2023-06-12 |
24% |
2023-09-22 |
Primary Endpoints |
NCT05173896 |
ETLAS2 | P2 |
Active, not recruiting |
Cerebral Small Vessel Diseases|Ischemic Stroke |
2024-09-23 |
2024-12-10 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
|
NCT05179876 |
PLATYPUS | P3 |
Recruiting |
Hypertension, Pulmonary |
2027-01-31 |
18% |
2025-03-27 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments |
ACTRN12620000204943p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Alzheimer Disease |
2020-05-12 |
|||
CTR20180385 |
CTR20180385 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
CTR20170603 |
CTR20170603 | P1 |
Active, not recruiting |
Prostatic Hyperplasia|Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
CTR20180076 |
CTR20180076 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
2023-506791-27-00 |
NOPRODPAPUH3001 | P3 |
Recruiting |
Hypertension, Pulmonary |
2027-12-13 |
2025-05-02 |
Treatments |
|
2014-004786-25 |
2014-004786-25 | P3 |
Completed |
Hypertension, Pulmonary |
2024-09-27 |
27% |
2025-07-09 |
Treatments |
JapicCTI-132356 |
JapicCTI-132356 | P3 |
Active |
Hypertension, Pulmonary |
None |
|||
NCT04762082 |
P-002-2020 | P1 |
Not yet recruiting |
Erectile Dysfunction |
2025-08-30 |
50% |
2024-07-23 |
Primary Endpoints |
NCT06553937 |
C1B03967 | P1 |
Completed |
Healthy Volunteers |
2024-06-03 |
2024-08-15 |
Primary Endpoints|Treatments |
|
NCT06553924 |
C1B03346 | P1 |
Completed |
Healthy Volunteers |
2024-05-31 |
2024-08-15 |
Primary Endpoints|Treatments |
|
CTR20202557 |
CTR20202557 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/09/2026 |
News Article |
Public Advisory - Fake Cialis and Viagra seized from Bitco Distribution in Ontario |
|
01/06/2026 |
News Article |
Vella Bioscience Appoints Industry Innovator Joy Allen-Altimare as President, Accelerating a New Era of Femtech, Hormonal Health, and Science-Led Sexual Wellness |
|
12/24/2025 |
News Article |
Public advisory - Unauthorized health products seized from two stores in Maple Ridge, BC may pose serious health risks |
|
12/05/2025 |
News Article |
UPDATE - Public Advisory - Fake Viagra and Cialis seized from Rocky Convenience in Toronto, Ontario |