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Also known as Alfuzosin (SL770499), SL770499
Alfuzosin · 9 trials · 11 indications
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.
Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point. 'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney. 'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney.
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
| Arm | Type | Description |
|---|---|---|
| Placebo, Then Alfuzosin | PLACEBO_COMPARATOR | Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. |
| Alfuzosin, Then Placebo | EXPERIMENTAL | Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. |
| Alfuzosin solution - 2-7 years | EXPERIMENTAL | Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. |
| Alfuzosin solution - 8-16 years | EXPERIMENTAL | Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight \< 30 kg. |
| Alfuzosin tablet - 8-16 years | EXPERIMENTAL | Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day |
| Alfuzosin 0.1 mg/kg/day | EXPERIMENTAL | - |
| Alfuzosin 0.2 mg/kg/day | EXPERIMENTAL | - |
| 1 | ACTIVE_COMPARATOR | Alfuzosin 10mg |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Alfuzosin-matched One tablet once daily |
| Alfuzosin | DRUG | 10 mg once daily |
| alfuzosin (SL770499) | DRUG | - |
Inclusion Criteria: * Male, 30-69 years of age * Has mild to moderate Erectile Dysfunction with a score \< 25 on EF domain in IIEF * AUA score of less than or equal to 14 * Negative urinalysis with no evidence of a Urinary Tract Infection Exclusion Criteria: * Blood pressure \< 90/50 or \> 170/11...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Medicus Pharma Ltd | MDCX | 1 | PHASE2 | Teverelix DP |
Alfuzosin is a small molecule under development for urology indications including acute urinary retention, benign prostatic hyperplasia, erectile dysfunction, hydronephrosis, neurogenic urinary bladder, and prostatic hyperplasia. It is being developed by Sanofi (ticker SNY) and is currently in Phase 2 development.
Alfuzosin targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D. It acts as an agonist at these receptors. This receptor activity is the basis for its development in urological conditions such as benign prostatic hyperplasia and neurogenic bladder dysfunction.
Alfuzosin is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for the clinical development program of alfuzosin across its urology indications.
Alfuzosin is in Phase 2 of clinical development. It is an investigational small molecule and has not been approved by the FDA for the indications being studied. The development program includes completed Phase 3 trials in specific pediatric and adult populations.
Alfuzosin has been studied in completed trials including NCT00893113 in men with erectile dysfunction and mild lower urinary tract symptoms, NCT00629720 in children and adolescents with elevated detrusor leak point pressure, NCT00576823 in children and adolescents with hydronephrosis, and NCT00549939 in children and adolescents with neurogenic urinary bladder dysfunction.
Yes, alfuzosin is also known by the code name SL770499. Both names refer to the same small molecule developed by Sanofi for urological conditions.