Tadalafil is named as an intervention in 16 current clinical trials in our Egypt, France, China, Italy, Denmark, Brazil and Australia registers. 15 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Beni-Suef University (3). The most-studied condition is Erectile Dysfunction. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Tadalafil was first approved in the EU on 12 Nov 2002. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Tadalafil. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Prospective, Open-Label, Single-Center Pilot Study on the Efficacy of Daily Tadalafil in Early-Stage Parkinson’s Disease
2025-521819-39-00 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Ongoing | Amsterdam UMC Stichting | Netherlands |
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
31 single-substance products containing Tadalafil on the HPRA medicines list.
No entry for Tadalafil in the EMA, FDA or German BfArM shortage lists we track.
| Condition (as registered) | Trials |
|---|---|
| Erectile Dysfunction | 3 |
| Pulmonary Arterial Hypertension (PAH) | 2 |
| Erectile Dysfunction Following Radical Prostatectomy | 2 |
| Prostate Cancer | 2 |
| Comorbidities | 1 |
| Cardiovascular Disease (CVD) | 1 |
| Pulmonary Hypertension | 1 |
| Chronic Obstructive Pulmonary Disease | 1 |
| Prostate Carcinoma | 1 |
| Erectile Function | 1 |
| Genito Urinary Cancer | 1 |
| Cerebral Small Vessel Diseases | 1 |
| Stroke, Ischemic | 1 |
| Radical Prostatectomy | 1 |
| Urinary Incontinence Following Surgical Procedure | 1 |
| Erectile Dysfunction With Diabetes Mellitus | 1 |
| Kidney Stone | 1 |
| Ureteric Stone | 1 |
| Safety | 1 |
| Efficacy | 1 |
| Tamsulosin | 1 |
| Monotherapy | 1 |
| Vasculogenic Erectile Dysfunction | 1 |
| Tadalafil | 1 |
| IVF | 1 |
| Infertility, Female | 1 |
| Overactive Bladder (OAB) | 1 |
| Overactive Bladder Syndrome | 1 |
| Acute Urinary Retention | 1 |
| Benign Prostatic Hyperplasia | 1 |
| Benign Prostatic Obstruction | 1 |
| Lead sponsor | Trials |
|---|---|
| Beni-Suef University | 3 |
| Assistance Publique - Hôpitaux de Paris | 2 |
| Ain Shams University | 2 |
| Al-Azhar University | 2 |
| Second Affiliated Hospital, Zhejiang University, School of Medicine | 1 |
| Regina Elena Cancer Institute | 1 |
| Christina Kruuse | 1 |
| Biozeus Biopharmaceutical S.A | 1 |
| Surgical Outcomes Research Centre (SOuRCe) | 1 |
| Aswan University Hospital | 1 |
| Mansoura University | 1 |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
16 current trials in our Egypt, France, China, Italy, Denmark, Brazil and Australia registers name Tadalafil as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.
Yes. 15 of the 16 trials are recruiting: 9 with sites in Egypt, 2 with sites in France, 1 with sites in China, 1 with sites in Italy, 1 with sites in Brazil and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Beni-Suef University (3), Assistance Publique - Hôpitaux de Paris (2), Ain Shams University (2) and Al-Azhar University (2), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 31 single-substance products containing Tadalafil, for example Cialis for men 10 mg film-coated tablets (A. Nattermann & Cie. GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Tadalafil has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tadalafil works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tadalafil works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tadalafil (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.