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: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belarus, Belgium, Bulgaria, China, Hungary, India, Japan, Korea, Poland, Russia, South Africa, Taiwan, Ukraine, United States
Active Clinical Trial Count: 14
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Erectile Dysfunction|Hypertension, Pulmonary|Prostatic Hyperplasia
Phase 1: Alzheimer Disease|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| PLATYPUS | P3 |
Recruiting |
Hypertension, Pulmonary |
2027-01-31 |
32% |
2025-03-27 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments |
| P-002-2020 | P1 |
Not yet recruiting |
Erectile Dysfunction |
2025-08-30 |
50% |
2024-07-23 |
Primary Endpoints |
| DKF-313-P3 | P3 |
Completed |
Prostatic Hyperplasia |
2023-06-12 |
24% |
2023-09-22 |
Primary Endpoints |
| 2006-7041-83/hah | P1 |
Not yet recruiting |
Alzheimer Disease |
2020-05-12 |
|||
| NOPRODPAPUH3001 | P3 |
Recruiting |
Hypertension, Pulmonary |
2027-12-13 |
2025-05-02 |
Treatments |
|
| AUT16661 | P3 |
Recruiting |
Erectile Dysfunction |
2026-01-31 |
15% |
2025-02-26 |
Primary Endpoints|Treatments|Trial Status |
| 2014-004786-25 | P3 |
Completed |
Hypertension, Pulmonary |
2024-09-27 |
30% |
2025-06-08 |
Treatments |
| C1B03967 | P1 |
Completed |
Healthy Volunteers |
2024-06-03 |
2024-08-15 |
Primary Endpoints|Treatments |
|
| C1B03346 | P1 |
Completed |
Healthy Volunteers |
2024-05-31 |
2024-08-15 |
Primary Endpoints|Treatments |
|
| CTR20202557 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
| JapicCTI-132356 | P3 |
Active |
Hypertension, Pulmonary |
None |
|||
| CTR20180385 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
| CTR20170603 | P1 |
Active, not recruiting |
Prostatic Hyperplasia|Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
| CTR20180076 | P1 |
Recruiting |
Erectile Dysfunction |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/16/2025 |
News Article |
Public Advisory - Health Canada warns about unauthorized sexual enhancement products seized from stores in B.C. and Ontario that may pose serious health risks |
|
06/05/2025 |
News Article |
AgelessRx Introduces Tadalafil Daily in Continued Pursuit of Healthspan Innovation |
|
06/02/2025 |
News Article |
Grünenthal announces acquisition of the rights to Cialis® from Lilly in Mexico, Brazil & Colombia |
|
05/22/2025 |
News Article |
Onconetix, Inc. Announces Receipt of Additional Notice from Nasdaq |