At the 2025 Sexual Medicine Society of North America meeting in Grapevine, Texas, urologist Amy Pearlman, MD, spoke with Hans-Jürgen Gruss, MD, chief medical officer of a US- and UK-based biotech company developing a new investigational therapy for premature ejaculation (PE). Gruss explained that his interest in the field stemmed from decades of clinical research focused on quality-of-life disorders in urology. Premature ejaculation, affecting an estimated 6%–8% of men, remains a significant unmet need—particularly in the United States, where no treatment has received Food and Drug Administration approval. Existing strategies, such as topical delay sprays, pelvic-floor therapy, and off-label antidepressants, often yield inconsistent outcomes or undesirable side effects. The company’s candidate, KH-001, is derived from a plant long used in traditional South African medicine. The active alkaloid targets the serotonin transporter, acting through the same molecular pathway as selective serotonin reuptake inhibitors (SSRIs) but with distinct pharmacologic advantages. Preclinical and early clinical findings indicate that KH-001 binds selectively and with high potency to the serotonin receptor without affecting other central nervous system targets, suggesting a potentially improved safety profile. Unlike conventional SSRIs, which require chronic daily use to achieve efficacy, KH-001 has demonstrated rapid absorption and clearance in healthy volunteers, enabling an on-demand dosing approach. Men would take the oral therapy approximately 15 minutes before sexual activity, with no accumulation or prolonged systemic exposure. The goal is to offer a treatment that minimizes long-term adverse effects while delivering consistent, time-specific efficacy. The pathway toward FDA approval presents both opportunities and challenges. Because the United States lacks an approved PE therapy, regulators must first define meaningful clinical endpoints. Gruss emphasized the importance of establishing consensus on outcome measures, such as intravaginal ejaculation latency time and patient-reported satisfaction, as well as refining patient-selection criteria. Internationally, dapoxetine—an SSRI approved in more than 60 countries—provides a regulatory precedent, though it has not been licensed in the US due to efficacy-threshold questions. Both experts noted that defining sexual dysfunction by strict timing thresholds oversimplifies a highly variable experience. Individual expectations, partner dynamics, and situational factors all influence how men perceive their sexual performance. More flexible, patient-centered endpoints may better capture meaningful improvements in intimacy and quality of life. If successful in clinical development, KH-001 could represent a first-in-class, plant-derived, fast-acting oral therapy designed specifically for premature ejaculation. Its introduction would fill a long-standing therapeutic gap and expand the landscape of men’s sexual-health options beyond current behavioral or off-label pharmacologic approaches. References: Kanna Health. Kanna Health announces FDA and MHRA approvals to begin its Phase 1 clinical trial for the development of KH-001 as first FDA-approved treatment for premature ejaculation. BioSpace. Published November 16, 2023. Accessed October 14, 2025. https://www.biospace.com/kanna-health-announces-fda-and-mhra-approvals-to-begin-its-phase-1-clinical-trial-for-the-development-of-kh-001-as-first-fda-approved-treatment-for-premature-ejaculation Martijn Vosbergen. Premature Ejaculation. SMSNA. Published 2025. Accessed October 14, 2025. https://www.smsna.org/patients/conditions/premature-ejaculation

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