Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)

Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic
effect through stimulation of V2 receptors in the kidney and is being developed for the
treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at
night one or more times to void, is a common condition and shows an age-dependent increase in
both prevalence and severity (number of nocturnal voids). It has a significant detrimental
impact on the quality of life in patients with benign prostatic hyperplasia (BPH).

The purpose of this study is to determine the efficacy and safety of fedovapagon in the
treatment of nocturia with BPH.

Inclusion Criteria:

- Adult males ≥18 years [no upper limit]

- Benign prostatic hyperplasia

- Persistent nocturia despite previous lifestyle modification advice including
appropriate fluid management

- Serum sodium not below lower limit of normal prior to randomization

- Provide signed and dated informed consent before any study-specific procedures are
conducted.

- Able to comply with the requirements of the study.

Exclusion Criteria: