Tadalafil: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Tadalafil appears in the FDA drug-label database. Marketed as tadalafil.
- Drug class
- Phosphodiesterase 5 Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Phosphodiesterase 5 Inhibitors (as stated on the FDA label)
FDA-approved use
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. — Preferred Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2023-03-23 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| CGMP Deviations — Northwind Pharmaceuticals LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2023-03-16 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
Phase breakdown
Conditions being studied
Recruiting trials involving Tadalafil
- Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
- COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities
- Comparison of Sequential to Initial Combination Therapy in PAH
- Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Common questions
Is Tadalafil FDA-approved?
Yes, marketed as tadalafil.
How many recruiting trials involve Tadalafil?
4 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.