Chemistry:KH-001

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KH-001 is an atypical serotonin reuptake inhibitor (SRI) and phosphodiesterase (PDE) inhibitor which is under development for the treatment of premature ejaculation.[1][2][3][4][5][6][7] It is taken on-demand orally.[1][3][4][6]

The drug is a purified alkaloid derived from the South African plant Sceletium tortuosum (kanna).[6][4][5] It is said to be selective and to have high potency as a serotonin reuptake inhibitor and phosphodiesterase inhibitor.[3][6] In addition, KH-001 has atypical properties as a serotonin reuptake inhibitor, including a rapid onset of therapeutic effectiveness rather than requiring chronic administration.[3] KH-001 has been found to increase latency to ejaculation in male rats treated acutely with para-chloroamphetamine (PCA) to induce ejaculation.[5][6] The pharmacokinetics of KH-001 in humans have been studied.[6] It showed a rapid onset and a short duration.[6] The drug is described as a potential first-in-class medication.[3]

KH-001 is under development by Kadence Bio (formerly Kanna Health).[1][2] As of November 2024, it is in phase 1 clinical trials.[1][2] Phase 2 trials were planned to begin in 2025.[8] The chemical structure of KH-001 does not yet appear to have been disclosed.[1] However, Kanna Health patented synthetic analogues of mesembrine with activity as serotonin reuptake inhibitors in 2023, with KH-001 being indicated as one of the compounds in the patent.[7][8][9]

See also

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 "KH 001". 5 November 2024. https://adisinsight.springer.com/drugs/800069314. 
  2. ↑ 2.0 2.1 2.2 "Delving into the Latest Updates on KH-001(Kanna Health) with Synapse". 8 May 2025. https://synapse.patsnap.com/drug/e86d6119e0124ac39de6615bd02639ce. 
  3. ↑ 3.0 3.1 3.2 3.3 3.4 "Pearls & Perspectives: Advancing Premature Ejaculation Care With a Novel On-Demand Therapy". 14 October 2025. https://www.urologytimes.com/view/pearls-perspectives-advancing-premature-ejaculation-care-with-a-novel-on-demand-therapy. "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. If successful in clinical development, KH-001 could represent a first-in-class, plant-derived, fast-acting oral therapy designed specifically for premature ejaculation." 
  4. ↑ 4.0 4.1 4.2 "British Society for Sexual Medicine (BSSM) Position Statement on Premature Ejaculation". The World Journal of Men's Health 43 (3): 510–522. July 2025. doi:10.5534/wjmh.240262. PMID 40034027. "Oxytocin antagonists are currently under development for PE as is oral KH-001 a natural alkaloid derived from the Sceletium tortuosum plant also known as Kanna, used for centuries in South Africa for mood and performance enhancement.". 
  5. ↑ 5.0 5.1 5.2 "(52) KH-001 but Not Other Tested Alkaloids Derived From Sceletium Tortuosum Delays Ejaculation in the Rat Para-Chloroamphetamine (Pca) Model". The Journal of Sexual Medicine 20 (Supplement_4). 6 July 2023. doi:10.1093/jsxmed/qdad062.002. ISSN 1743-6095. https://academic.oup.com/jsm/article/doi/10.1093/jsxmed/qdad062.002/7220149. Retrieved 27 January 2026. 
  6. ↑ 6.0 6.1 6.2 6.3 6.4 6.5 6.6 "(059) First-in Human Study Investigating KH-001 Besylate as a Novel On-Demand Treatment for Premature Ejaculation: Pharmacokinetic and Safety Evaluation". The Journal of Sexual Medicine 22 (Supplement_4). 9 December 2025. doi:10.1093/jsxmed/qdaf320.059. ISSN 1743-6095. https://academic.oup.com/jsm/article/doi/10.1093/jsxmed/qdaf320.059/8375008. Retrieved 27 January 2026. 
  7. ↑ 7.0 7.1 "Novel compounds and uses thereof". 22 July 2022. https://patents.google.com/patent/WO2023004428A1/. 
  8. ↑ 8.0 8.1 "Kadence Bio Pioneers Innovative Therapies for Sexual and Mental Health". 10 January 2026. https://www.science-entrepreneur.com/blog-posts/kadence-bio-pioneers-innovative-therapies-for-sexual-and-mental-health. 
  9. ↑ "Kanna Health announces publication of patent application for KH-001 as a treatment for premature ejaculation". 30 June 2022. https://www.prnewswire.com/news-releases/kanna-health-announces-publication-of-patent-application-for-kh-001-as-a-treatment-for-premature-ejaculation-301578852.html. 



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